Blog Tag: PDP

In a speech in Cambridge on December 11, 2014 (which was reported on in an article in the Boston Business Journal), Dr. Bill Maisel– the science chief of the U.S. Food and Drug Administration’s center to oversee approval of medical devices – addressed long-standing complaints that the time to approve trials and new devices was too long.

According to the Boston Business Journal, Maisel spoke before members of MassMEDIC, Boston’s advocacy group for the medical device industry, and his speech was part of a daylong FDA Update event intended to give an overview on hot topics in regulatory approval in 2015.

The article reported that the FDA is on track to “meet or exceed” its own deadlines for approval and has worked in the past 2-3 years to cut half of its backlog of applications.  As for the coming year, Maisel was quoted as stating that his priority is “strengthening the clinical trial enterprise.”

The article also stated that the FDA has cut down the average length of time of the submission of an application to conduct a clinical trial to decision by 75% in the past three years (from an average of 400 days to 2011 to 101 days this year).

According to the article, Maisel also remarked that the FDA was taking other steps to expedite approvals including:

• reviewing categories of devices considered high-risk to see if any of them can be downgraded; and
• the possibility of an “Expedited Access PMA” program – an accelerated approval program for companies developing products designated as high risk but in areas with significant needs.

More information for the FDA’s Monthly PMA (Premarket Approval)/PDP (Product Development Protocol) Decisions and Summary Statistics can be found here.