FDA 510(k)A 510(k) submission is required in the U.S.to receive clearance to market almost all class II medical devices.  While the 510(k) preparation process is not as onerous as preparing a Premarket Approval (PMA), it has its own challenges and pitfalls. We recently completed a 510(k) submission and I’d like to share some of the wisdom and lessons learned from this experience.

  1. Prepare your regulatory strategy as early as possible

Smaller startup companies are always mindful of the cost of medical device development. A regulatory strategy is often seen as something they don’t really need in the beginning of the development process. However, a lack of regulatory strategy may lead to design decisions that don’t comply with regulatory requirements. Therefore, identifying regulatory requirements early on is important. The regulatory strategy also needs to be regularly updated in case the regulatory landscape changes or new regulations come into place. For our recent project, the initial strategy did not include human factors and usability testing as it was not required when the project started. However, a testing requirement was in place at the time of submission and it had a huge impact on the budget and timeline. The summative testing cost tens of thousands of dollars and required significant time to complete.

  1. Choose a suitable predicate device

A predicate device is a legally marketed device to which equivalence is claimed. Selecting a suitable predicate device can make or break a 510(k) clearance and the foundation of a 510(k) application. Choose a predicate device as early in the medical device development process as possible. The device code and regulation number provide valuable information on indication for use and required regulations. These should be added to the product requirements document. Device labeling and performance also have an important role in predicate selection.  The device should perform as good as. or better than, the chosen predicate.

It is important to fully understand the technological characteristics of the predicate device, the relevant specifications,  and the testing needed to demonstrate substantial equivalence. What specific tests should be performed? Is the substantial equivalence testing feasible and easy to perform? You may find yourself scrambling at the end to figure out how to determine substantial equivalence. This is especially true if you didn’t address it appropriately at the beginning of the design development process.

  1. Begin to write the 510(k) as early as possible

Begin writing the 510(k) as early as possible in the development process. Outline all the testing needed and ensure that Device History File (DHF) documents are clearly written and reviewer friendly. If, for example, your architecture document has a clear and detailed device description section, you can use it to jump start your 510(k) device description. Also, make sure to discuss the 510(k) content periodically with the development team in order to identify any gaps in testing or documentation.

  1. Labelling and claims

Discrepancies in labelling and claims are the most often cited deficiencies in a Refuse to Accept (RTA) response. Small discrepancies in the indication for use and labelling claims throughout the 510(k) will result in an RTA. Careful review and Quality Control of the submission are needed to avoid this common pitfall. If you are providing an instruction manual as part of the device labeling, it is important that the device description be consistent with the 510(k) device description section, otherwise the reviewer may be confused.

  1. Pre- Submission Meeting

The Pre-Sub process is a great opportunity to receive clarification and free advice from the FDA while compiling your 510(k). You can receive clarification and answers to questions or uncertainties about the testing and information you are including in the submission. A Pre-Sub meeting is also a great opportunity to get the FDA familiar with your device prior to the submission. You can start building a relationship with the review team. It is best to submit the draft testing protocols along with a testing summary if you have questions about the testing you are planning to conduct. Without the details provided in the testing protocol, the FDA may not be able to provide specific feedback.

Plan to receive written feedback and a meeting date to occur 75 to 90 days after you submit the meeting request.

  1. Submission clearance will take 6 to 9 months

The timeline for the 510(k) review by the FDA is 90 days if everything in the submission is clear and in good order.  However, it often takes at least a couple of rounds of questions from the FDA before the review is finalized.  Having a realistic 510(k) clearance timeline is important to avoid pressure from investors and management.  Also keep in mind that every time the FDA sends a request for additional information, the review clock stops until the response is provided.

  1. Plan for Additional Questions

Companies often plan a budget, time and resources for the 510(k) submission, but overlook planning resources for additional questions after the 510(k) is submitted. Answering FDA questions can be difficult and time consuming. This activity can sometimes take as much time as the 510(k) preparation itself. The tricky part here is that you can never predict how many questions the FDA will have. This makes planning a challenge.

If the questions are not clear, you can reach out to the reviewer for clarification. Make sure you fully understand all the questions and prepare an action plan for answering them. You may disagree with some of the questions. In this case it is essential to provide a strong justification for your position.

  1. The 510(k) submission must be detailed, clear and thorough

In the past, FDA would accept summaries of testing and results in a 510(k) submission. This has changed in recent years. Now, test plans, protocols and test reports are expected to be submitted for review. In particular, any testing performed to recognized standards (such as electrical safety testing, biocompatibility or sterilization) should be submitted in full.

The information in the 510(k) submission should be detailed, clear and thorough. Simplify the information as much as you can. A good rule of thumb is to use somebody who is not familiar with the project to review the 510(k) content. A fresh pair of eyes can identify gaps and areas that are unclear.

  1. Use the RTA Checklist

When your 510(k) submission arrives at the FDA, the reviewer uses the RTA checklist to ensure all content is present. You can find this list at the FDA website and use it to make sure all required content is included in the 510(k). You can also ask somebody to act as an independent reviewer and use the RTA checklist to review the 510(k). It is a good idea to provide a copy of the completed RTA checklist in your submission to help the reviewers find information and speed up the review.

Keep all of the above in consideration to help make the 510(k) clearance process smoother and improve clearance timelines.

Virginia Anastassova, RAC, is the Regulatory Affairs Manager/ Senior QA Specialist at StarFish Medical. She brings extensive experience in quality management and regulatory affairs to our clients.


Leave a Reply

Your email address will not be published. Required fields are marked *