Washington Legal Foundation Joins Minnesota Medical Device Alliance in Bashing 510(k) Process

By Jim Dickinson

The Washington Legal Foundation (WLF) has sent comments to FDA supporting a January 2, 2013, Minnesota Medical Device Alliance petition claiming that through a combination of guidance documents and regulatory actions, FDA has transformed the 510(k) process from one that encouraged development of new and innovative medical devices into one in which caution has become the overriding consideration. WLF notes that over the past four decades, the vast majority of new medical devices have reached the market through the 510(k) process.

“The success of the 510(k) process is being threatened, however, by recent changes in the manner in which FDA is administering the process,” asserts the WLF, a nonprofit legal organization that champions free enterprise and individual rights.

“The review procedure is being transformed into one whereby, instead of determining whether a new device is as safe as existing devices, FDA is evaluating whether the device meets some absolute level of safety. Importantly, this transformation is taking place without encouragement from Congress.”

The WLF comment letter says the results of the agency’s policy change “have been devastating: many smaller device companies are facing financial ruin, and product clearance or approval can take so long that American consumers often do not gain access to innovative products until several years later than their European counterparts.”

According to WLF, a significant share of the blame for the situation is attributable to inadequate supervision of FDA medical device reviewers, who are not receiving clear instructions that absolute assurance of safety is rarely attainable and that clearance is warranted under federal law whenever a new device is shown to be as effective as the predicate device. The advocacy group also blames FDA guidance documents that it says have shifted the 510(k) process away from the streamlined process intended by Congress. It particularly joins in calls for FDA to withdraw its December 27, 2011, draft guidance on evaluating substantial equivalence in 510(k)s.

Finally, the group says that even if FDA were correct in its interpretation of the laws applying to the 510(k) process, it is required by law to use formal notice-and-comment rulemaking rather than guidance documents.

Jim Dickinson is a contributing author to MD+DI. 

[stock image courtesy of KIBSRI/FREEDIGITALPHOTOS.NET]