How to make 510(k)s more okay

The U.S. Food and Drug Administration announced in mid-January that it was going to embark on a large, multifaceted set of steps aimed at improving the 510(k) process for clearing new medical devices for marketing.

Nowadays, many categories of medical devices are completely exempt from having to file any kind of premarket notice or application with the FDA before entering the market. Among those that do have to file something, the vast majority file notifications under the 510(k) program, which is easy to explain and harder to practice. The easy explanation is that it involves simply a demonstration to FDA that a company’s medical device is “substantially equivalent” to a preexisting medical device that is legally on the market.

This is a process that has been amplified and improved over the years, but is still fraught with uncertainty and inconsistency for device makers and packagers. Making the process more efficient and predictable would be welcome. Packagers of new medical devices often find themselves struggling with questions about exactly whether their particular medical device is or isn’t exempt from having to file a 510(k), and if not exempt, what exactly they are required to file.

Although the conventional wisdom is that a 510(k) rarely if ever requires clinical studies (controlled experiments in people), sometimes they do, and knowing clearly in advance whether you do or don’t could make the difference between pursuing a new product or not doing so because it is too expensive.

So now come these recommended actions, and they have been divided into these categories: Industry guidance; internal and administrative manners; programmatic and regulatory matters; and issues to be referred to the Institute of Medicine. Among the guidance aimed at helping the industry understand the process will be some that clarify when changes do or do not warrant a submission of a new 510(k), and providing great clarity about when clinical trials are necessary.

The FDA got together two working groups that came up with 55 recommendations last August, which have now been translated into 25 separate actions.

Significantly, the FDA is not afraid to put in writing its commitment to these 25 steps, even including dates for completion for each of the 25, all of which are in 2011. The one working group was supposed to evaluate the 510(k) program to explore ways to improve FDA’s decision-making under it, and the other was supposed to make recommendations on how to “quickly incorporate new science--including evolving information, novel technologies, and new scientific methods--into its decision-making in as predictable a manner as practical.”

One of the issues FDA is referring to the Institute of Medicine is to look into adding a whole new class of devices called Class IIb, sort of a higher-end Class II to add to the existing Classes I, II, and III. The concept of Class IIb devices would be those “for which clinical information, manufacturing information or, potentially additional evaluation in the post-market setting would typically be necessary to support a substantial equivalence determination.”

FDA assures the industry that there are still plenty of opportunities to give input and shape the final form of a lot of these recommendations. They are talking about having a public meeting in April to get additional feedback on some recommendations. In short, stay tuned for further developments.

Eric Greenberg can be reached at greenberg@efg-law.com, and visit his firm’s Web site.