Originally Published MDDI March 2005
Get It Right the First Time
The need to meet MDUFMA performance goals is one reason why FDA is no longer giving device firms more than one or two shots to fix a deficient 510(k) application.
FDA has been showing less patience with firms that submit incomplete or poorly organized applications. Why? In large part, because it wants to shorten review times to meet Medical Device User Fee and Modernization Act of 2002 (MDUFMA) goals. Therefore, it has never been more imperative for device companies to submit complete, well-written applications the first time around. Failure to do so could be disastrous.
This is especially true for 510(k) submissions, which are not supposed to take very long to review. Before MDUFMA, there were no restrictions on how many review cycles a 510(k) application could have. Now that is no longer the case.
A guidance issued in May 2004 discourages CDRH from extending 510(k) applications past two review cycles. According to the guidance, if unresolved deficiencies exist following FDA's review of a response to a second formal request for additional information (AI), FDA will issue a Not Substantially Equivalent letter. In other words, after the initial 510(k) submission, companies get two shots to fix any deficiencies. If it's still lacking, the application is likely to be rejected outright, regardless of the merits of the product.
This provision is designed to help CDRH meet its MDUFMA goals of 75% of 510(k)s receiving a decision within 90 days, 70% receiving a first AI request within 75 days, and 70% receiving a second AI request within 60 days of a response to the first one.
In some cases, however, companies may be getting only one shot to fix deficiencies. More than ever, industry simply cannot afford to submit sloppy or incomplete applications.
“It's not an official policy, but I've been told by reviewers that they will only send one letter requesting additional information, and then, if it's still not right, it gets an NSE decision. This is a fairly recent development,” says Sheila Hemeon-Heyer, director of regulatory services for consulting firm MDCI (North Attleboro, MA). “That means you really have to put the time in and make the submission as good as possible up front. A lot of companies say ‘not all the information is there, but let's submit the application anyway.' FDA does not accept that anymore.”
A firm can do several things to alleviate the problem. One is to hire a consultant who has experience putting 510(k) applications together and who understands how they should be organized and what must be included.
Another is to submit the application to a third-party reviewer instead of directly to CDRH. Third-party reviewers are also unlikely to look favorably upon poorly constructed applications, but they are not bound by MDUFMA's review-time goals. They may be more patient with firms that send in deficient submissions.
Third, if a 510(k) has clinical data, the firm should meet with FDA before submitting the application, says Robert Gatling, director of the program operations staff for CDRH's Office of Device Evaluation. “We may be able to tell you if we think your data won't be sufficient to support the claims in your application,” he says.
And, most basically but most importantly, firms need to read all the laws, regulations, and guidances concerning 510(k) applications. Gatling says it's shocking how many don't. (The list of information required for a 510(k) can be found in 21 CFR 807.87.)
All of these solutions may add time or expense to the process. But that is far preferable to the alternative—a worthwhile product that never sees the market only because its sponsor put the 510(k) application together so poorly.
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