New FDA ‘guidance’ offers little of it

November 21, 2014

ShapiroMedical device law specialist Jeffrey K. Shapiro of Hyman, Phelps & McNamara says the FDA’s recently released standards on medical device recalls vs. medical device enhancements didn’t point the industry in a definite direction.

There are many ways device performance issues can arise, and the FDA didn’t address them.

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Shapiro finds it troubling that the agency’s final guidance definition of “device enhancement” does not explicitly state whether those modifications cover devices already in the field or confined to future production.

“A guidance is supposed to clarify regulatory requirements, not introduce new uncertainties,” he says.

Jeffrey K. Shapiro is a director at Hyman, Phelps & McNamara in Washington.  He has specialized in medical device law, advising and representing companies before the Food and Drug Administration for more than 20 years.  He has experience in FDA regulation of medical devices, including product clearances and approvals, labeling and advertising, and recalls.  This commentary originally appeared Oct. 23 on the firm’s FDA Law Blog, www.fdalawblog.net.  Reprinted with permission.