Feb 06, 2019
What to Expect After You Submit Your 510(k) Application to FDA
FDA does not publish a specific template for the 510(k) application, but they do want you to organize it into 20 specific sections. Sections 14-20 may not be applicable, depending on your device. While there is no specific template to follow, FDA does provide a thorough overview of what is expected in each section here – you should start by reading this page, as it contains links to numerous other guidance documents that pertain to each section.
Sections of a 510(k) Application
|1||Medical Device User Fee Cover Sheet (Form FDA 3601)|
|2||CDRH Premarket Review Submission Cover Sheet|
|3||510(k) Cover Letter|
|4||Indications for Use Statement|
|5||510(k) Summary or 510(k) Statement|
|6||Truthful and Accuracy Statement|
|7||Class III Summary and Certification|
|8||Financial Certification or Disclosure Statement|
|9||Declarations of Conformity and Summary Reports|
|12||Substantial Equivalence Discussion|
|14||Sterilization and Shelf Life|
|17||Electromagnetic Compatibility and Electrical Safety|
As we mentioned before, the average 510(k) submission is 1,200 pages long! These days FDA reviewers spend about twice as much time reviewing each submission as they did 15 years ago, and much of that increased scrutiny is directed at specific testing and clinical results found in sections 14-20. Also, in the past FDA might have assigned one reviewer to a 510(k) but today several reviewers are involved, including specialists in biocompatibility, electrical safety, and risk management.
Be Prepared: Additional Information (AI) Requests Are Common
When you submit your 510(k) to FDA, the first hurdle is to have it accepted for substantive review. If your submission does not pass FDA’s 50+ point checklist, they will kick it back to you. You certainly don’t want that to happen when you’ve spent months preparing your 510(k), double-checking all details, and following all FDA guidance documents.
Theoretically, in less than three months you should have a clearance letter from FDA in hand and a pat on the back from your boss. But don’t uncork the champagne just yet – nearly two-thirds of all premarket notification submissions receive an ego-deflating Additional Information (AI) request from FDA. For minor issues, this could take the form of a simple phone call from the FDA reviewer (Interactive Review), but for more substantial questions an AI letter will be issued. Common issues that spur an AI request include:
- Inadequate device description or discrepancies throughout the application.
- Discrepancies or problems related to indications for use (e.g., your indications don’t match throughout the submission).
- Failure to follow published guidance or standards.
- Missing performance testing or clinical data (rookie mistake: submitting summaries and not full testing reports and protocols).
- Skipped sections. Perhaps your device does not have biocompatibility issues, but you can’t just say “not applicable” and move on – you need to acknowledge the requirement and say why your device does not require biocompatibility testing.
Also, despite the bounty of information published by FDA, sometimes a reviewer asks for information that may not have been published in any FDA guidance document or standard. This does happen and, if it happens to your submission, you will need to deal with it. If an AI request is submitted to your firm, your submission is placed on hold for up to 180 days (just as with the RTA discussed above). If you are unable to supply the requested information within that timeframe, your 510(k) submission may be withdrawn or cancelled, which means you will need to submit again…and pay the review fee again. That’s not a discussion you want to have with your boss.
Typical FDA 510(k) Review Cycle (Calendar Days)
Despite what you may have read, it is unusual to get a 510(k) cleared in less than three months. Plan on six months from the hopeful day you submit until the joyous occasion when you pop the champagne cork and are holding the substantial equivalence letter in your hand. In all fairness, because such a high percentage of companies receive AI requests from FDA, the amount of total time that FDA spends reviewing your submission is only slightly longer than the amount of time companies spend replying to FDA AI requests. The average time to clearance is around five or six months but that also varies by medical specialty.
Why 510(k) Submissions Get Rejected as NSE
It can be the most soul-crushing letter any regulatory professional could receive: the dreaded not substantially equivalent (NSE) letter from FDA. While more than 3,000 submissions get blessed by FDA each year, hundreds don’t make the cut. Even if devices accepted for substantive FDA review and their sponsors reply to AI requests, some of the applications get rejected. Why? Typically, an NSE letter is issued because no matching predicate exists, the device has a different intended use, the device has different technological characteristics, or performance testing does not support safety and efficacy of the device. If a device is rejected because no predicate exists, companies may be able to request a risk-based classification from FDA via a De Novo petition.
In addition to the applications that are rejected, hundreds more are abandoned (withdrawn) because the sponsor of the 510(k) could not produce the necessary testing or data requested in the AI letter.
Your Device Is Substantially Equivalent: The FDA Letter Every Company Wants to Receive
Luckily most companies do not get NSE letters and have the pleasure of cracking open the champagne to toast their hard work and success. The substantially equivalent (SE) letter is not an approval by FDA, but it serves the same purpose because it legally authorizes the holder to market the device in the US. Unlike other countries, no certificate will be issued by FDA but your SE letter will be posted on the FDA website along with your 510(k) summary. Your 510(k) clearance will not expire and is valid until you make changes to the intended use, alter the indications for use, or change technological characteristics. At the time your 510(k) clearance letter is issued, you are expected to be in full compliance with the FDA Quality System Regulation (21 CFR Part 820) when distribution of the device begins in the US.
Getting FDA clearance for a medical device is a lot of work and a huge accomplishment. If you spend time doing your homework, you can be assured that your path to 510(k) success will be shorter, smoother, and more likely to result in you securing the coveted substantially equivalent letter.
Want to Learn More About Preparing a 510(k) Application?
We hope you have enjoyed this series on the 510(k) process. If you are getting ready to start your first 510(k), consider our training class on FDA and European regulatory submissions. It’s held regularly in various US cities. Also, the Oriel STAT A MATRIX team of FDA experts is available to help you with 510(k) strategy, review, or compilation.
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