This Regulatory Alert discusses:
- The most impactful FDA CDRH guidance documents issued in 2019 including the 5 issued related to the 510(k) Program and the 5 issued, for digital health. We also cover new guidance documents for the De Novo Program, Q-Subs, 513(g) requests, Patient Engagement, Annual Reporting, the Safer Technologies Program, and changes to eCopy submissions.
- Ten things you can do to speed along your 510(k), PMA, or De Novo submission.
- An age-old question: Is FDA guidance binding?—i.e., does it have to be followed?
1. The group of five 510(k) guidances issued in September 2019
We are loathed to give you a big reading assignment, but #1 on our list is not just one guidance - it’s the group of new 510(k) guidances. If you have a 510(k)-cleared product on the market or plan to submit a 510(k) in the future, then you should familiarize yourself with the five new guidance documents FDA released in September 2019 intended to modernize and clarify expectations related to the 510(k) program. See below for details on each guidance.
2. Five Digital Health guidances issued in September 2019
Number two on our list is another bundle of five guidances. FDA issued five guidance documents on September 27, 2019, all related to digital health content, including mobile medical applications and medical device software, to keep pace with the rapid technological advancements in the digital health space. If your current or future products include a digital health component, then you should familiarize yourself with current FDA thinking on how your product is, or is not, regulated. See below for details on each guidance.
3. De Novo Guidance
CDRH’s mysterious De Novo program requirements are fleshed out in this 2019 guidance which provides checklists for what you need to include in your De Novo submission. Because this guidance lays out the “must have” and recommended elements of a De Novo request, it is indispensable for anyone submitting a De Novo. See below for details on the De Novo program and new guidance.
The following are some additional 2019 CDRH guidances that you should know about.
What are 10 things you can do to speed along your 510(k), PMA, or De Novo submission?
- Don’t guess. When in doubt, ask the FDA. Consider a pre-sub or 513(g) Request for Information. Proactive FDA interaction will save you time down the road.
- Know the FDA guidance(s) applicable to your device and submission pathway. Is there a Special Controls guidance?
- Engage an expert to compile and/or review your submission. Writing for the FDA requires a unique skill set.
- Do not promote your investigational device before it is approved—this is not allowed per 21 CFR 812.7. Reviewers often visit company websites to learn about a company and its device.
- Adequately budget and staff your assignment. An inadequately-provisioned ship may only make it half-way across the ocean.
- Establish reasonable timelines to clearance or approval.
- Don’t set out on the 510(k) pathway when your device belongs on the De Novo or PMA pathway. The path to clearance or approval is littered with companies that have chosen the wrong pathway and gone bankrupt as a result.
- Get it right the first time. Mistakes will shake the confidence of your FDA reviewer.
- Consider whether a pre-submission meeting is necessary, e.g., these are often unnecessary for less complex submissions.
- Work collaboratively with the FDA. Be firm when necessary. But remember that the Agency has a job to do. Don’t be combative or unnecessarily escalate disagreements. Use the CDRH Office of the Ombudsman if you have a concern about how your submission is being treated.
FDA guidance documents are not law or regulation. With limited exceptions, they contain “non-binding recommendations.” What does that mean?
To an outsider it means that they are optional recommendations. But those of us that have worked in this industry long enough know a company would be a fool if they failed to recognize FDA guidance for what it is: a true reflection of Agency expectations.
Companies are ill-advised to ignore them. You must stay abreast of FDA guidance documents in order to effectively do your job and meet business objectives, e.g., submit a 510(k) and obtain clearance. Why ignore the regulator? Doing so will only frustrate the FDA and impede your objective—a successful submission and a marketable device.
Failure to get your submission right the first time can delay product launch, prolong burn, and keep enhancements out of the hands of practitioners—which impacts patients.
Gardner Law has an intimate understanding of FDA’s regulations and current guidances related to regulatory submissions. We have summarized some of the recent guidance documents related to the FDA medical device submissions process above.
Drafting regulatory submissions to the FDA requires specialized skills and an intimate knowledge of FDA expectations and requirements. Gardner Law has extensive FDA regulatory submissions experience, including face-to-face and remote interactions with the FDA to discuss and successfully negotiate resolutions to complex submission issues. Our experience and knowledge is based on a hands-on understanding of FDA regulations and guidance documents as well as extensive industry practice.
Amanda Johnston, J.D., is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professional Society (RAPS) and leads the Gardner Law FDA submissions team. We have worked on nearly every kind of FDA regulatory submission for drugs and medical devices: PMAs, IDEs, 510(k)s, De Novos, NDAs, 513(g) Requests for Designation, Small Business Certification Requests, Breakthrough Designation, annual reports, product change submissions/supplements, and pre-submissions (Q-Subs).
Whether you have a brand new product that you are looking to commercialize or need regulatory assistance with a currently-marketed product, we can help with all aspects of FDA regulatory submissions and strategy. Gardner Law also possesses deep knowledge about product advertising and promotion laws, health care fraud and abuse, compliance programs, sunshine transparency laws, quality management systems, clinical research requirements, FDA enforcement actions, and privacy law that enables us to provide full-service counsel to FDA-regulated companies.