The FDA marketing clearance process (never “approval” for a class II or 510(k) device) can be maddeningly ambiguous, time-consuming, expensive, and risky if conducted incorrectly. There are, however, many companies that have a straightforward and relatively easy pre-market notification process. This article in MDDI lists a number of dos and don’ts to help you and your company end up in the latter category.
“Top Ten Pitfalls:”
- Misconceptions about 510(k)’s goals.
- Not knowing the regulatory history of your product in the United States.
- Choosing the wrong comparison (predicate) device.
- Choosing a predicate that is not available to test.
- Choosing a predicate that is not available in the U.S.
- Not understanding (or being able to find) appropriate guidance.
- Not starting validation testing.
- Errors and inconsistencies in the 510(k).
- Inattention to FDA’s instructions.
- Missing and incomplete forms.
My experience is that many people new to the 510(k) process misunderstand the FDA’s goals and role in the 510(k) process:
In the 510(k) review process, devices that meet eligibility requirements are “cleared” as opposed to being “approved” by FDA…The requirements and expectations for a properly completed 510(k) have evolved along with medical technology.
…the documentation must show that the device is “substantially equivalent” to a previously cleared (predicate) device. The device needs to have the same intended use and technical characteristics [as the predicate, but not necessarily the same technology]…The reviewers will also want to see data substantiating that the device’s performance, safety, and effectiveness are equivalent to the predicate.
Here are some of my own recommendations for avoiding FDA pitfalls:
- Hire a regulatory professional, either a consultant or an FTE. Give special consideration to the regulatory professional’s experience and field of expertise. You want someone who has extensive experience with products in the same regulatory classification and preferably the same medical specialty as your products. If you can’t afford to have the regulatory person manage the entire 510(k) process, negotiate to have them help you with planning and to review all part of the submission as well as any communications with FDA.
- Don’t second guess or micro-manage the regulatory professional. You should ask questions and have discussions, intense and challenging if necessary, about schedule, budget, indications, predicate device selection, test requirements and plan, clinical study requirements and plan, and so on. Once you have a recommendation, proceed. Trying to force an answer that is satisfactory to you will almost inevitably result in delays and increased expenses. If you find that you are spending a lot of time questioning your regulatory professional’s decisions, it’s probably not a good fit and you should find a new regulatory person.
- Do not second guess the FDA and do not ignore their questions or recommendations. Also, do not assume that you can rely 100% on their answers to your questions. The FDA will always tell you that their guidance is not a legal opinion and is not binding. As the saying goes, “you pays your money and you takes your chance.”
- On the other hand, don’t be afraid to ask questions of the FDA. This is particularly true if you fall into the “small manufacturer” category. You can get extra help free of charge from FDA staffers. Once again, however, do not rely exclusively on this guidance.
- If you are concerned about risk, timing, and/or expense, consider launching your product in another market first. You can generate much-needed cash flow and perhaps even obtain clinical data for your 510(k) submission in places like the EU or a country in South America.
Takeaways: Regulatory submissions and clearances are among the most important milestones in commercializing a medical device. It would be foolish to leave this important function to amateurs or to ignore important recommendations and guidance.
If you are a medical device startup CEO, marketing manager, or product manager and especially if you are without much regulatory experience, be sure to budget for and recruit a highly regarded regulatory professional with experience and expertise in your market and your regulatory classification. The regulatory clearance process is complicated and can be daunting to novices but it can be successfully navigated by engaging experts and by learning and following the rules.