Bradley Merrill Thompson Quoted in Article "Off-Label Promotion, Enforcement, 510(k) Revisions Are Key Issues for Industry in 2013"

Following is an excerpt:

Board member Bradley Merrill Thompson, with Epstein Becker Green in Washington, said that ''FDA has already published a draft guidance on mobile medical apps, but the other shoe to drop will be a policy on clinical decision support software.'' He said both of these guidances ''will have significant implications for companies outside of the traditional medical device industry.'' In addition, Thompson said that the ''digital revolution is finally disrupting healthcare, but the question is whether the information technology industry and FDA are ready for each other.'' ...

Thompson said that clarifying the rules for combination products is necessary. ''Every year I predict that FDA will release new rules on [good manufacturing practices] and adverse events for combination products, and I think this year I might actually be right,'' he said. ''In some ways these rules will reduce regulatory burden by reducing duplication. That's certainly a good thing. Unfortunately, they will require some effort to implement.'' ...

"Clinical labs and IVD [in vitro diagnostic] manufacturers have been tussling for years to establish an equal system of FDA regulation,'' Thompson said. ''FDA has been suggesting most recently that it plans to begin the process of tackling the high risk lab developed tests.'' '

"Congress has put obstacles in front of the agency, but at some point FDA is going to have to tackle the issue,'' he said. ''This might be the year.''

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