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

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.
      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.Click on the device name to see the regulatory attributes such as medical specialty, 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.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

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.