Author: Soumya Mahapatra

GSPR for EU MDR and EU IVDR

What is GSPR (General Safety And Performance Requirements) for EU MDR and EU IVDR?

Posted on | by Soumya Mahapatra
Manage GSPR (General Safety And Performance Requirements) in Essenvia

What is GSPR?

The GSPR stands for General Safety and Performance Requirements as listed in Annex I of EU MDR 2017/745 and EU IVDR 2017/746. These requirements are similar to the Essential Requirements under MDD 93/42/EEC.

The GSPR has 23 requirements under EU MDR and 20 requirements under EU IVDR. The manufacturers who wish to get CE mark for their device have to establish conformity with these requirements and should provide sufficient evidence to demonstrate compliance with GSPR. GSPR is a core element to navigate CE marking for a device.

GSPR Chapters and Requirements Guide:

EU MDR 2017/745EU IVDR 2017/746
Chapter 1 – General requirements (1 to 9)Chapter 1 – General requirements (from 1 to 8)
Chapter 2 -Design and Manuf. (from 10 to 22)Chapter 2 – Performance, Design and Manuf. (from 9 to 19)
Chapter 3 –Labels and IFU (23)Chapter 3 – Labels and IFU (20)

Essential Requirements for EU MDD and EU IVDD

The Medical Device Directive (MDD) defines the “Essential Requirements”, as the requirements that every medical product has to fulfill, according to the scope they belong to. These essential requirements are described by Directive in Annex I, 93/42/EEC for EU MDD and 98/79/EEC for EU IVDD, and there are in total 13 requirements.

Essential Requirements Chapters and Requirements Guide:

EU MDD 93/42/EECEU IVDD 98/79/EEC
Chapter 1 – General requirements (1 to 6)Chapter 1 –General requirements (from 1 to 5)
Chapter 2 -Design and Manuf. (from 7 to 13)Chapter 2 -Performance, Design and Manuf. (from 1 to 8)

Layout and Structure of the GSPR

The General Safety and Performance Requirements (GSPR) are divided into the following 3 chapters:

1. General requirements

  1. Intended purpose, safety of patients, users and other persons
  2. Reduction of risks
  3. Risk management system
  4. Risk control measures
  5. Risks related to use error
  6. Device performance shall not be adversely affected
  7. Device design, manufacture, packaging
  8. Risk reduction, acceptable risk-benefit ratio
  9. General safety requirements for devices without an intended medical purpose as described in in annex XVI

2. Requirements regarding design and manufacture

  1. Chemical, physical and biological properties
  2. Infection and microbial contamination
  3. Devices incorporating a substance considered to be a medicinal product and devices that are composed of substances/substance combinations that are absorbed by or locally dispersed in the human body
  4. Devices incorporating materials of biological origin
  5. Construction of devices and interaction with their environment
  6. Devices with a diagnostic and measuring function
  7. Protection against radiation
  8. Electronic programmable systems – devices that incorporate electronic programmable systems and software that are devices in themselves
  9. Active devices and devices connected to them
  10. Particular requirements for active implantable devices
  11. Protection against mechanical and thermal risks
  12. Protection against the risks posed to the patient or user by devices supplying energy or substances
  13. Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons

3. Requirements regarding the information supplied with the device

  1. Label and instructions for use

Essential Requirements vs GSPR

EU MDR and EU IVDR replace the EU MDD and EU IVDD for CE Mark in Europe. As shown in the table above, the Essential Requirements of the MDD are divided into 2 chapters with 13 items while MDR has 3 chapters with 23 items. This means that the changes from MDD have not only shifted quite a bit, but the scope of the details in requirements has also increased considerably with MDR.

To understand the extent of changes, items covering “Information provided by the manufacturer” from Chapter 2 in Essential Requirements have now been reorganized and incorporated into a new chapter 3 in GSPR.

Additional requirements and some administrative simplification for MDR come from the fact that the MDD has been combined with AIMDD (Active Implantable Medical Device Directive ER) and is now covered within GSPR Item 19. Further, in MDR’s GSPR a number of topics have been given greater emphasis or have been dealt with in more detail.

Besides expanding on some key aspects, several topics are newly incorporated in the requirements list of the GSPR. These include but are not limited to:

  • Requirements for devices that administer (GSPR 10.3/4) or contain drugs (GSPR Item 12)
  • Specific requirements for devices that contain tissues of human or animal origin (GSPR 13)
  • Requirements for disposal (GSPR 14.7/23.4)
  • Requirements for IT safety (GSPR 17.4)
  • Requirements for devices for use by lay persons (GSPR 22)
  • General requirements for labelling (GSPR 23)

Chapter 1 of GSPR

Chapter 1 in GSPR has many similarities with the MDD. However, there is a higher emphasis on usability and dependability along the product life cycle and the state of the art. Paragraphs 2 – 5 of Chapter 1 stress on risk management and the importance of medical devices. While paragraph 9 of Chapter 1 addresses devices without an intended medical purpose, the other paragraphs are very similar to the MDD and depict the “standard” requirements for every medical device.

Chapter 2 of GSPR

Key highlights as it pertains to changes from chapter 2 of GSPR are outlined below:

  • Paragraph 10 provides more details for the chemical, physical and biological properties, especially as it relates to handling of toxicity and specific substances
  • Paragraph 11 addresses requirements on infection and microbial contamination
  • The scope in paragraph 12 is extended to include substances absorbed or locally dispersed by the human body
  • Paragraph 13 now includes non-viable human tissue in the biological tissue category
  • New regulations have also been added for the interaction of medical devices with the environment (paragraph 14) and the compatibility with other devices
  • Network and cybersecurity has grown in importance within the global medical device diaspora and as such they are given high importance in the GSPR
  • Regulations for mechanical and thermal risks as well as risk reduction have also become more detailed

Chapter 3 of GSPR

In chapter 3 of GSPR, paragraph 23 “label and instructions for use” is covered in detail. In general, this chapter handles significantly more requirements, such as the format of the instructions for use, readability, comprehensibility, availability, and how this relates with laypersons in addition to professionals. This chapter also covers additional requirements that must be fulfilled for UDI labeling as well as devices containing human or animal tissue. The same applies to the labeling of sterile packaging or the indication of Carcinogenic Mutagenic and toxic to Reproduction (CMR) substances.

Transitioning from MDD to MDR and from IVDD to IVDR

From 26th May 2020 to 25th May 2024, CE mark certificates issued under the MDD, before the MDR fully applies, will be valid for up to 4 years. From 25th May 2022 to 25th May 2024, CE mark certificates issued under the IVDD before the IVDR fully applies may remain valid for up to 2 additional years. From 26th May 2024, all devices placed on the market must be in conformity with the MDR or IVDR.

Below is an infographic showing the transition timeline for medical device manufacturers in Europe:

MDR and IVDR Transition Timeline - GSPR (Essenvia)
MDR and IVDR Transition Timeline

Challenges of Maintaining GSPR

From a regulatory point of view, there has been no fundamental shift with the introduction of GSPR. It is still crucial that the safety and performance of medical devices are proven. This must be acceptable within the given clinical context and the manufacturer needs to ensure that the two components do not change significantly during the entire life cycle of the medical device. That is why a systematic risk management process is required, which must be updated constantly, even after the device is in the market.

Yet another challenge with the GSPR lies with the fact that many state-of-the-art requirements from harmonized standards have been incorporated directly into the MDR. However, no annex from the harmonized standards refers to the GSPR in the MDR currently. Meaning, manufacturers will still need to perform a careful gap analysis in order to establish the relation until no uniformity exists between the two.

The objective evidence that the GSPR is fulfilled is part of the Technical File. Also, during the selected conformity assessment procedure, it must be proven that the requirements in GSPR are fulfilled.

Best Practices to Streamline GSPR For your Medical Devices

GSPR as such is not just another document to be updated, but rather a critical artifact that guides the development process and decisions from the outset for a manufacturer. Therefore, medical device manufacturers should promptly prepare a new checklist for the General Safety and Performance Requirements (GSPR) according to Annex I of MDR and IVDR to ensure the new GSPR is implemented and complied timely.

Using the GSPR checklist is practical and ensures traceability and completeness, but the number of items and the ongoing process of adding references to evidence and methods of conformity in the form of searching and linking 100s of standards, evidence documents, or procedures especially as they change and evolve requires the constant upkeep and maintenance of GSPR for products.

Essenvia’s Regulatory Management tool allows you to easily maintain GSPR for your products and variants. It serves as a single source of truth that links to standards databases and evidence documents and reports within the platform, helping you easily cross-reference methods of conformity whether these are harmonized standards, procedures from your quality system, or testing reports. Easily create, publish and link new versions of the GSPR with the Technical File to maintain compliance with Annex I requirements for the MDR. Start a free trial today to get started or schedule a demo with the Essenvia team.

Posted in EU

What do Regulatory Specialists need to know about searching the FDA 510(k) Database for Regulatory Strategy

Posted on | by Soumya Mahapatra

Overview

Medical device manufacturers who intend to introduce a device into commercial distribution in the United States must submit a premarket notification – 510(k) or PMN to the FDA.This rule is applicable whether you are introducing a device for the first time, or planning a reintroduction with significant modifications. To ensure this rule is followed, you must leverage the information found in the FDA 510 (k) database.

This regulatory submission allows the FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. These categories include: Class I or Class II- with or without exemptions or Class III Premarket Approval (PMA).

If your device is classified as Class I or II, and if it is not exempt, a 510(k) will be required for marketing.

510(k) Submission Pathway:

A 510(k) is a premarket submission that needs to be sent to the FDA to demonstrate that the device to be marketed is safe and effective. It will also prove the device is substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

Once the device is determined to be substantially equivalent and cleared by FDA it can then be marketed in the U.S. The substantially equivalent determination is usually made within 90 days. This determination is based on the information submitted by medical device company seeking the clearance.

However, before you decide whether your device is eligible for the 510(k) pathway it is critical that you understand the regulatory strategy for your device.

The important elements of a regulatory strategy include:

  • FDA Product Code
  • Regulation Number
  • Proposed Indications For Use
  • Testing requirements
  • Product and device-specific guidance documents

In the paragraphs to follow we explain how the FDA 510(k) database is the ideal resource for medical device manufacturers to assess and determine their regulatory strategy to market.

How to use the FDA 510(k) Database to assess your regulatory strategy:

FDA maintains a database of previously cleared 510(k)s on its website. Typically, they will add new devices around the 5th of each month for devices cleared in the prior month. Users can search for previously cleared 510(k) submissions from this database using search criteria such as but not limited to:

  • 510(k) Number
  • Applicant Name
  • Product Code
  • Device name

Steps to performing an efficient 510(k) database search:

The following steps outline how to use the FDA 510(k) database to create your regulatory strategy and manage ongoing updates:

  1. Prepare your 510(k) search criteria:

    1. For creating an effective regulatory strategy it is extremely important to take a methodical approach. The first step, therefore, is to document the technological characteristics, the intended use, and the desired indications of use for your device. Also, identify intended users of your product. This may include patients, caregivers, or healthcare professionals.
    2. Build your initial keywords list based on the important attributes describe the technology (for example a needle, a catheter, etc.). This key word list also includes the indications and mode of action for the device. These keywords are attributes that when combined represent your device.
    3. Identify and list your competitors and the devices they have marketed or received approval for. We will talk about how to use this information later in this article.

  2. Perform a search of the 510(k) database

    1. There are two ways to run an efficient search on the FDA 510(k) database: (1) Quick search and (2) Advanced search. We will discuss how to leverage each of these search methods to optimize this FDA resource.A quick search on the 510(k) database with your keywords is helpful to identify a list of devices that match your device category.Below is an example of how this search works using an apnea monitor as the device
    2. Click search to view the list of devices that have a name apnea on them. This lists the devices with the keyword Apnea in them with decision dates and applicant information, all of which is valuable information that you can use for your own application.
    3. Click on the device name to see the regulatory attributes such as medical speciality, common name, and regulation number, and text. Scan the list and note down the products and regulatory attributes that look relevant. Also, click on the 510(k) Number and note down additional details for further use in the advanced search.
    4. The advanced search screen (shown below) is helpful when you already have key data on your competitors such as their 510(k) number or three letter product code. It is also helpful if are already confident the device in questions is similar to yours.

  3. Assimilate results, compare relevant attributes, and rank order search results

    Now that you have collected product code, regulations, and summary documents of possible similar devices, it is time to compare them with your technology, indications, mode of action and components. As well as, identifying the one that is closest to your device.This will then help you identify the applicable tests and guidance documents relevant to your device. This will inform your broader regulatory strategy and therefore your budget and timelines to go to market.

  4. Managing Regulatory strategy and ongoing regulatory Intelligence

    Regulatory assessment is a task that medical device companies must complete regularly in order to stay current with the latest regulatory changes. It is paramount that regulatory teams maintain a proactive approach to understand and assess the impact of changes to regulations, standards, and new guidance documents published by FDA, as well as device recalls of similar devices or changes in the product category.

    Methods used today include manually searching in guidance documents, standards databases, recalls and MAUDE reports databases that FDA has made available for public search. A slightly more sophisticated approach is subscribing to a plethora of industry journals, attending conferences, subscribing to FDA newsletters and notifications to stay up-to-date.

    The problem with this approach is regulatory affairs specialists and leaders end up consuming a lot of data from disparate data sources and struggle to make sense out of it all. This requires an audit of these sources to narrow down the information relevant to your device. Then, you need to assess what you just learned and recommend a course of action. With the number of rapid changes occurring every day, these approaches quickly become unmanageable.

Limitations of the current process to search in FDA 510(k) Database:

Whether you are using keywords-based search or competitor data for regulatory strategy, these searches can take hours. You also risk the possibility of omission due to the time the number of records that need to be reviewed.

Evaluating competitor technology could be helpful. However, elements such as technological characteristics, materials, and mode of action do not always equal a device that you can use to show substantial equivalence.

Therefore, finding the right substantially equivalent device seldom involves a straightforward strategy. Instead, it is the result of hours of careful preparation of a combination of keywords. This list that can identify a list of devices already in the market and then doing a couple of passes to compile a list of devices and technology.

The siloed process of passively managing regulatory attributes, strategy, and search criteria while spending hours scouring the internet is time-consuming and prone to error. Reviewing the regulatory attributes alongside the technology profile will help you identify the ideal devices to use to establish substantial equivalence.

A better way to manage regulatory search and intelligence

What if there is a way to combine all the steps mentioned above and streamline the entire process? A tool that can allow you to preview and analyze critical regulatory attributes for specific devices that are ranked by relevance based on your list of keywords.

What if you were are able to pull the documents from previous searches? What if your team could leverage a system that understands important attributes and can also notify you when changes occur.

As busy regulatory specialists, leads, and executives in medical device companies, your strength lies in your ability to make great decisions substantiated by data points. Therefore access to relevant regulatory information curated without noise can save hours and sometimes days and it can be a long-term competitive driver of medical device innovation.

How Medical Device Companies Can Gain A Competitive Advantage By Transforming Their Regulatory Affairs Operations

Posted on | by Soumya Mahapatra | Leave a Comment on How Medical Device Companies Can Gain A Competitive Advantage By Transforming Their Regulatory Affairs Operations

When you are in the early stages of developing a medical device, over half of your activities are regulatory-related. Therefore, having an optimized and efficient regulatory affairs operations is critical. It will be the difference between getting your device to market on time or suffering a crippling setback.

Automation is one of several key factors that allow you to optimize your entire regulatory affairs process. Without it, you leave yourself wide open to an array of potential mistakes. For example, manually compiling over 1,100 pages of content can lead to an accident such as omissions an discrepancies.

These critical errors can cause delays that cost your company thousands, if not millions of dollars. Depending on your current financial situation, that might be a type of loss your company cannot recover from. This type of financial setback can turn those avoidable missteps into fatal ones.

However, the right automation tool can transform your regulatory operations and make sure this never happens. The key is to invest in a platform that provides you with crucial submission insight. This includes a complete go-to-market strategy, understanding the required testing your device needs to complete, and more. Leveraging the power of automation is a choice you cannot afford not to make.

The Rapid Evolution of Regulatory Policies

Regulatory rules and policies change and shift at a rapid rate. Medical device companies are constantly facing the challenge of balancing these regulatory requirements with the commercial viability of the device they are bringing to market. Failing to strike the right balance in this area can be the difference between your device getting to market and watching it die before it even has a chance to succeed. It is up to a companies regulatory affairs team to balance these competing priorities.

However, a team is only as effective as the operational process they implement and follow. It’s important to understand the importance of an optimized regulatory process. To do this we must better understand the complexity and magnitude of the rapidly evolving library of regulatory requirements. Only then can we truly grasp the workflow required to manage the widening range of medical technologies.

The Role of Regulatory Affairs

The sheer number of relevant guidance documents, testing protocols, and submission checklists a regulatory affairs team must include in their submission presents a massive challenge. This high volume of data and information presents several potential areas for mistakes. If you are not careful, your chances for a successful pre-market application in jeopardy.

Not to mention, submitting regulatory submissions is only part of the job description for regulatory affairs specialists.. They also contribute to the regulatory strategy by gathering competitive intel using the FDA 510k database and coordinating with cross-functional teams.

They also must consistently monitor changes to product codes, guidance documents, and standards. This issue can be seen on full display when looking at the FDA’s refuse-to-accept rate when it comes to reviewing regulatory clearance applications.

A surprising 31.3% of applications get rejected before even initiating the review process and are forced to withdraw due to errors. This requires your team to go back into the 1,100+ page document, find and correct the mistakes, and start the process again. This delay in getting your device to market can cost your company millions of dollars.

Managing Your Cross-Functional Teams

It takes a village to manage the regulatory process for a medical device. While one person may run point on the entire project, they rely on significant help from their cross-functional teams. This includes design, labeling, sterilization, clinical and quality departments. For this type of collaboration to work, all relationships must be built on the following four pillars:

  1. Ensuring everyone has access to the latest regulations, guidances, forms, and templates required by the regulatory authorities you are submitting into.

  2. Following project management procedures that create a seamless workflow amongst all cross-functional teams.

  3. Identify and eliminate/reduce repetitive manual tasks that only serve to delay progress and cause errors.

  4. Establishing a relationship with a regulatory affairs expert who can provide specific guidance based on your device based and the regulatory testing required by the region you are launching in.

Setting up these pillars at the start of your regulatory pathway is vital. Once your initial regulatory strategy is set up, the cross-functional teams listed above will be responsible for supplying various types of documentation for your submission. The data and content will be based on several factors, including the type of device, applicable regulations, changes to the device, manufacturing site, materials, and more.

Having Access To The Latest Regulations Guidance Documents That Impact Your Device

The average length of a 510(k) submission has reached 1,185 pages. This is a staggering 150% increase since 2009 and a direct result CDRH’s actions to clarify and strengthen 510(k) submission expectations. The FDA and European Commission (EC) have issued hundreds combined new guidance documents with 50% of them being released in just the last two years alone.

These new guidance documents can have a significant impact in the trajectory of your device. Furthermore, these consistent updates force your regulatory team to spend 4-6 hours a week keeping up with the latest developments. This is a time that can be much better spent working with cross-functional teams to collect and review all content before it is added to the submission.

Guidance documents are crucial to the regulatory lifecycle of your device because they identify several key changes. This includes, but is not limited to: UDI Management, device registration, and listing management. Failure to stay up to date on these changes can result in the aforementioned fatal mistakes we mention earlier.

Eliminating Costly Mistakes and Expediting Time To Market

One of the most time-consuming parts of compiling a regulatory submission is collecting, organizing, and revising key content such as tables and graphs. In addition, once all of your tables and graphs are uploaded, you must make sure they are correctly numbered.

However, what happens when a team member sends you a new table or graph that needs to be placed amongst the assets you already have in place? This often results in having to go through and re-number the majority of the list. These types of manual tasks only serve to waste time and increase your chances of making a costly mistake.

Asset numbering is just one of several types of administrative tasks your team is responsible for executing. This type of extended manual labor increases the odds of making a crucial mistake. Furthermore, once everything has been double-checked, it is then time to publish your 1,100+ page submission into a format that the regulatory body will accept.

This administrative burden will add weeks to your regulatory submission timeline. Optimizing your process by using automation tools makes sure that does not happen. The right tool will re-number your remaining assets after an addition has been completed. Automation tools go through a complete checklist to ensure you have included every step you need to complete.

No matter how long you have been working on regulatory submissions, it’s unreasonable to think you can learn everything. This is because of how rapidly things change in the medical device regulatory industry. With everything else going on, you do not have time to keep on top of everything. Leveraging an automation tools makes sure every box is checked, every document is formatted correctly, and you end up with rejection-proof and regulatory body-abiding submission.

Having Access To An Expert That Understand The Regulatory Requirements For Your Device

While your team may be excellent at creating and organizing content and data, they will undoubtedly run into an issue they cannot solve independently. The regulatory requirements for each device vary based on several factors, and it can be challenging to understand which applies to your device. Optimizing your regulatory process becomes meaningless if you don’t understand which steps you need to take.

Regulatory consultants are external experts who have the knowledge and experience to help you understand the regulatory landscape for your specific device. They can also be beneficial depending on the location you are seeking clearance in. For example, if you seek clearance outside your primary country, you must work with an authorized representative in-country. The right regulatory expert can walk you through this entire complex process.

Let’s Recap

Optimizing your regulatory operations saves serious time and money. The regulatory lifecycle of your medical device is long and complex. Without automation, you are forced to perform tedious administrative tasks that open you to all types of errors and delays. The right automation tool takes all of this off your plate and provides the peace of mind you need to move forward to compile an accurate regulatory submission on time and under budget.

About Essenvia

Essenvia is a regulatory lifecycle management tool designed to help you automate the entire regulatory operation process. Our solutions include an innovative approach to building both your 510(k) and MDR submissions. Our software is designed to reduce errors, streamline processes, and guarantee faster regulatory clearance for your medical device.

To try out our automation tool for free, please click here.

To better understand how your tool can benefit you, please schedule your free demo.

Essenvia Spaces: All Your Medical Device Data In One Place

Posted on | by Soumya Mahapatra | Leave a Comment on Essenvia Spaces: All Your Medical Device Data In One Place

Being in charge of a device’s regulatory information is complicated enough. Being tasked with managing this type of data for various devices can be overwhelming. Even if you are only working on one device, you deserve the ability to organize and manage files, processes, and projects related to regulatory submissions.

Essenvia was born out of a need to streamline the regulatory process throughout the entire lifecycle of a medical device. Spaces is the latest step in that journey.

What is ‘Spaces’?

Currently, on the Essenvia platform, every project created for a specific medical device operates in its own silo. In other words, if a piece of your device’s master information changes in one project, you must manually make this change in the other projects. Spaces solves this tedious and time-consuming issue.

‘Spaces’ is shorthand for ‘Device Workspace,’ and it’s our solution to help you manage all the regulatory submissions related to a particular medical device. As an account administrator or space owner, you can create a ‘Space’ for each device you are working on.

Then, you create all projects associated with the device in its own dedicated space. This way, you only need to fill in the Master Information once. Then, it will be automatically cascaded into all projects related to the device. This removes the need to re-enter the exact details repeatedly for each submission.

A Must Have For Managing Multiple Devices

Spaces are vital in efficiently managing multiple projects and documents for the same medical device. It is also the ideal solution for regulatory managers in charge of managing a portfolio of devices. Regulatory consultants who support multiple projects and clients simultaneously can take advantage of the advanced permissions features. It is now easier for consultants to manage permissions for their customer’s regulatory projects, files, and devices.

Spaces was designed to optimize how a device’s regulatory management as it moves from stage to stage. Our tool ensures crucial information, files, and data stay consistent. It also allows sharing and collaboration to be easily managed. This is a key component when creating an expedited and accurate regulatory submission.

Aligning On Your Device’s Key Information And Other Medical Device Data

A core function of the Essenvia platform is to capture your Master Information at the beginning. This includes all of your applicant, device, and regulatory details. Spaces ensures that the vital information you entered at the start is shared across all the projects (submissions) within the space. If that information suddenly changes, those changes are then automatically cascaded across all submissions.

Spaces ensure that the data we collect is shared with every member of your team. When everyone is working off the correct information, the likelihood of errors and delays drops significantly.

If a piece of your master information changes, your entire team must be notified. Otherwise, you have team members creating documents with outdated data. That type of mistake can force you to waste time fixing errors. Even worse, if it is not caught in time, it could cause your regulatory authority to reject your submission entirely.

Tracking Your Team’s Access and Permissions

Pushing a device through critical regulatory milestones requires plenty of help from your functional teams. Spaces are perfect for providing a central location to make their contributions. However, we are fully aware that some contributors require more access than others. Plus, your internal team members will likely need greater access than external vendors

Spaces allows you to keep complete control over who has access to your space and how much they can do and see. In addition, our varying permission levels will enable you to grant access based on need. For example, a design agency creating your images does not need the same level of access as a research specialist or project manager.

Track All Key Aspects Of Your Space and Medical Device Data

A medical device will encounter hundreds of changes throughout its regulatory lifecycle. This will include new submissions, key information updates, tables, reports, files, etc. Spaces allow you to track all the activity within the space so that you have an activity log that captures all the updates or changes as required by the regulatory authorities

How To Learn More About Spaces

Spaces was created to optimize the regulatory process across the entire lifecycle of your medical devices. Our latest feature is ready to help streamline managing different submissions for each device, reducing repetitive work and errors, and manage all aspects of your device’s regulatory life cycle.

Sign up for a free trial, CLICK HERE.

If you are interested in scheduling a demo session, CLICK HERE.

To learn more about Essenvia and the features we offer, CLICK HERE.

5 Reasons You Shouldn’t Submit Your 510(k) Submission Alone

Posted on | by Soumya Mahapatra | Leave a Comment on 5 Reasons You Shouldn’t Submit Your 510(k) Submission Alone

First, you conceptualize your idea for a new medical device. Your team has determined what medical issue it is going to resolve and how it will be used. Then, you research the current state of the market to understand the level of need and how to best position it. Your cross-functional teams spend time designing your device and ensuring it is easy to use. Finally, you are ready build your 510(k) submission to submit your device for FDA clearance.

 Obtaining FDA clearance for your device involves submitting a 510(k) application. This application is normally over 1,100 pages and requires a plethora of information. The sheer size of this application will leave you open to all types of mistakes. Theses mistakes can lead to your application being rejected.

The FDA will provide general guidance regarding what needs to be included in a 510(k) application. However, they provide little else in terms of document organization or project management. This often leaves submitters alone with a checklist and blank Microsoft word document. Then forced to wrangle hundreds of pages of information such as packaging labels, clinical trial reports and more.

In this post, we cover the top 5 reasons why you should not go it alone when submitting your 510(k) application.

#1 – You Need To Have The Most Up To Date FDA Documents

Your 510(k) application, you will include several places that require FDA documents. The FDA will supply these documents as they are necessary for submitting a complete application. However, documents and forms such as your Cover Sheet, Indication of Use, and Declaration of Conformity to a Recognized standard change often. It can be difficult to know if you are using the most up-to-date version. The last thing you want is to learn you are not compliant by having your application rejected.

These types of requirements can lead to errors among those who are doing this on their own. However, using a 510(k) application builder tool like ours ensures you always have to right templates. We automatically populate your application with the most up-to-date FDA templates. All you need to do is fill in the necessary information.

For example, the FDA requires a specific form for your device’s Indication of Use statement. This document explains what you plan to use your device for after receiving clearance. This is also a document that the FDA tends to update regularly. As anyone who has used the FDA website will tell you, these documents are not easily accessible. Our 510(k) builder always provides the most up-to-date form and automatically inserts it into your application.

#2 – Discrepancies and Errors Will Lead To Rejection Of Your 510(k) Submission

A key reason automation has become so popular in today’s society is it cuts down on both time and errors. Brands no longer require their sales reps to manually type out their outreach emails because it is highly likely there will be a typo or incorrect statement. The pitfalls of manual data entry are just as evident when it comes to 510(k) applications.

The application will require you to repeat the same key information such as indications for us and device descriptions in several places. For example, your indication of use statement is a key point that the FDA will review. Even if you are clear on what that statement is, it’s possible it can be phrased in several different ways.

If the reviewer feels this statement is inconsistent, they will reject your application. In our application builder, we ensure this type of content is consistent throughout your entire application. All you need to do is type it once and our Changelock™ function ensures your information cascades to all relevant sections throughout your application.

#3 – You Have A Lot Of People You Need To Communicate With

As the saying goes: If you want something done right, do it yourself. Regardless if you agree, one undeniably true fact is that you cannot compile the data and information you need for a 510(k) by yourself. As the project lead, you are required to communicate with several people both inside and outside your organization. This requires countless emails, dropbox folders, JIRA tickets, and anything else that delivers the content you require.

Ongoing communication amongst this many parties is ripe for confusion and errors. This is due in large part to your teammates not being well versed in regulatory terminology. They are also not nearly as knowledgeable as you are about the various requirements set by the FDA. Therefore, it is your responsibility to translate their work into content that follows the proper terminology and requirements.

A system must be put in place on day one. A process that allows you to get a handle on the various documents that are floating in your direction. You will benefit greatly from a program that helps collect this information and store it in an organized manner. This will relieve your stress and allow you to confidently move forward knowing you have the most up-to-date and accurate versions of everything you need.

#4 – The Fear and Anxiousness Of Getting You 510(k) Submission Wrong

Gaining FDA approval is a daunting and pressure-packed task. This is the major hurdle stopping your device from hitting the market and turning a profit for your organization. Key stakeholders including executives, shareholders, investors, and team members are looking for you to deliver. Messing up could mean a loss in revenue, decreased profits, and possibly even losing key investments. That scenario is enough to paralyze anyone with fear and anxiety.

While you cannot minimize the importance of a 510(k) application or decrease its size, you can determine the best way to approach it. This includes setting up a process that safeguards against errors, discrepancies, and the use of outdated documents. When you leverage the power of our app builder, you no longer fear making a crucial mistake such as using the wrong template or forgetting to update a section of your application. Your anxiety will significantly lessen knowing you took the necessary steps to produce an error-free and rejection-proof application.

#5 – Your Time Is Better Spent On Other Sections Of Your 510(k) Submission

The truth of the matter is your time is precious and better served working on other things. While putting together this submission may be your top priority, that does mean you have time to waste hunting down the latest FDA documents and ensuring the information people are sending you is up to date. Furthermore, it should not be your responsibility to then take these thousands of pages and attempt to use Microsoft Word to comply with the FDA’s mandated e-copy format.

On the topic of time-consuming tasks, it is worth talking about the RTA checklist that is required at the end of each submission. This is a time-consuming document that appears after you just spent countless hours compiling and formatting your entire application. Our software will automatically tell you which parts of this checklist apply to your device. Then, it provides a convenient function that allows you to answer the questions as you complete the section instead of at the end of the process.

We can’t perform most of the leg work for you but we will make it easier to compile and organize what you do collect. We also make sure you are not wasting your time worrying whether or not what you are submitting will be rejected by the FDA. The time we save you can be better spent tending to your other tasks and responsibilities.

Conclusion

Submitting a 510(k) application is a complex process that requires the help of an experienced expert. The sheer size of this project leaves most people open to errors and mistakes that result in being rejected. Our program has identified these common areas of mistake and provides solutions to ensure that they do not happen to you. Together, we can submit a 510(k) application that you can feel confident will be approved by the FDA.

About Essenvia

Essenvia is an online software to streamline pre and post-market workflow for medical device companies by streamlining plans or activities to market, improving cross-functional collaboration, and automating steps to manage initial and subsequent device modifications.

Our tool is designed to help drastically reduce submission errors, streamline data and information gathering, save time, and help you submit a close to rejection proof as possible 510(k) submission.

510(k) submission

The Top 5 Reasons The FDA Rejects A 510(k) Submission

Posted on | by Soumya Mahapatra | Leave a Comment on The Top 5 Reasons The FDA Rejects A 510(k) Submission

If you have ever put together a 510(k) submission, you know exactly how massive of an undertaking this project becomes. You spend hours and hours collecting data and documents from various departments. You then spend more time finding the right templates and trying to understand the FDA’s guidelines. Plus, you have to search for the most up-to-date templates to use. After all of this hard work, the last thing you want is to discover the FDA has rejected your application.

Unfortunately, this is what happens to over 64% of 510(k) applications submitted for FDA clearance. Over 30% of these applications are not even accepted for initial review. Having a worthy device and the content to back it up is not enough to achieve FDA clearance. In this post, we cover the 5 most common reasons a 510(k) gets flagged and to avoid it.

#1 – Using Incorrect Or Out of Date FDA Templates

There are several sections throughout your 510(k) submission that require you to use some type of FDA-issued form. These sections include your Medical Device User Fee Cover Sheet (From FDA 3601), CDRH Premarket Coversheet (Form 3514), Cover Letter, and Indications for Use (Form 3381). Each section requires you to use the latest FDA-approved template when submitting your application.

The FDA is regularly updating these templates which makes it increasingly difficult to keep yup. While using the wrong template may not result in an outright rejection, it does put your application at risk of leaving out key information. Essenvia’s 510k application builder will always supply you with the most up-to-date templates. This helps avoid wasting hours scouring the internet and hoping you found the right templates. Furthermore, you can submit your application in confidence and no longer worry about submitting an out-of-date template and missing key information.

#2 – Discrepancies In Information That Appears More Than Once

As we mentioned above, the quality of your device and the content you provide are only part of this complex process. The FDA is quite strict when it comes to consistency in the information you provide. For example, your Indication for Use Statement appears over 20 times in your application and the FDA requires it remains the same throughout. Even if the intent remains unchanged, your application will be flagged, paused, and possibly even rejected if the wording does not match up.

It may seem simple enough to pay extra special attention when repeating information throughout your application. However, what happens when something changes towards the end of your process? You are now forced to scan your entire document and manually make this change each time. With Essenvia, this tedious type of work is done for you. With our Changelock™ feature, once you make this change on one page, it cascades throughout your entire document. You no longer have to worry if you missed a section during your review.

#3 – Not Following The 510(k) Submission Refusal To Accept Checklist

As we mentioned earlier, over 30% of submissions are rejected before they are even reviewed by a real person. This is due to their failure to comply with the Refusal To Accept checklist. In simple terms, the RTA checklist is what the FDA uses to determine if your device meets the minimum threshold for review. This document proves that you are worthy of the FDA’s time and have a realistic shot of gaining clearance.

This checklist consists of 56 questions all about the content and information in each section of your application. If you want until the end to fill it out, you risk providing answers that are not consistent with what you provided earlier. It’s important to note that not every question applies to your device. Our application builder not only shows you which questions are applicable but allows you to answer them as you are putting your sections together.

#4 – Choosing The Incorrect Predicate Device For Your 510(k) Submission

As you may already be aware, the FDA requires all submissions to list a predicate device on their application. Essentially, it is your responsibility to select a device already on the market that is substantially equivalent to the device you are seeking approval for. This is one key way the FDA can determine if your device is safe and effective. You can review current devices and their information by searching the FDA’s medical device databases.

Your Indication of Use Statement must align with the predicate device you have chosen. Whatever you decide your device is going to do it must match up with what your predicate device already does. It is equally important that your device’s technological characteristics are similar to those of the predicate device you have chosen. To increase your chances of clearance, you can include a side-by-side comparison for the reviewer to examine.

#5 – Skipping Not Applicable Sections In Your 510(k) Submission

While a traditional 510(k) includes 20 sections, not every single one of them will apply to your device. This includes sections such as Class 3 Summary and Certification, Financial Certification or Disclosure Statement, Performance Testing (Bench and Clinical) Proposed Labeling, Biocompatibility, Sterilization, and Shelf Life, and Electromagnetic Compatibility and Electrical Safety. A common mistake made by first-time submitters is leaving these sections blank instead of using a standard not applicable statement.

Even if the section does not apply to you, you are still required to state that in writing. Our application builder software will auto-populate these sections with pre-approved statements. This allows you to move past these parts of the application and focus on those that are applicable and important.

Conclusion

As you can see, compiling the content and data is only half the battle. The FDA expects and requires you to follow various guidelines and procedures. These requirements are why investing in a support program like Essenvia will return a high ROI. Together, we can make sure you submit a rejection proof 510(k) application and that all of your hard work will be worth it.

About Essenvia

Essenvia is an online software to streamline pre and post-market workflow for medical device companies by streamlining plans or activities to market, improving cross-functional collaboration, and automating steps to manage initial and subsequent device modifications.

Our tool is designed to help drastically reduce submission errors, streamline data and information gathering, save time, and help you submit a close to rejection proof as possible 510k submission.