The Center for Devices and Radiological Health (CDRH) recently released an update on its 2014-2015 Strategic Priorities. This document summarizes the areas that CDRH is focusing on to ensure patients in the US have access to high-quality, safe, and effective medical devices. The current strategic priorities are: to strengthen the clinical trial enterprise, to strike the right balance between premarket and postmarket data collection, and to provide excellent customer service.

The FDA’s device center (CDRH) has established time based performance standards to help ensure draft guidance documents do not remain in an unresolved state for too long.  The following draft performance goals have been outlined:

We ran across an interview with Owen Faris in The Gray Sheet, acting clinical trials director for CDRH.  The position was established to help implement the several CDRH strategic priorities in 2014-15 that were announced in February focusing on speeding up the IDE review process and encouraging more IDE trials in the U.S.

Why in 2013 was there a record number of product recalls in the medical device industry?  The FDA claims the increase is due to manufacturers over-reporting and the increasing sensitivity to media reports about product problems, not due to because an increase in medical device problems.

Recently on November 14th, 2013, the FDA released a new draft guidance regarding medical device development tools.  Per the FDA release statement, the purpose of this new guidance is to “support the development and timely evaluation of innovative medical devices”.

One of the results from the recent two-week government shutdown is a backlog of government submissions.  Although during the shutdown, the FDA continued to review device submissions that were submitted prior to October 1st, the agency was prevented from accepting any new fiscal year 2014 user-fee funded device submissions, including PMAs and 510(k)s.

It is critical that the group of patients enrolled in a study represent the population that may receive the device once it is on the market. Certain medical devices could elicit different responses depending on gender, according to the federal watchdog agency. Basic differences such as genetics, hormones, body size, diet and socio-cultural issues may play a role in the efficacy of medical devices in patients, according to FDA.

Just released on FDA’s website concerning The Center for Devices and Radiological Health (CDRH) is a posting that reads “Data Standards and Terminology Standards for Information Submitted to CDRH” which is intended to benefit device manufacturers, hospitals, and clinical investigators. But what exactly are the benefits to data and terminology standards?

For quite some time we’ve watched the blame for slow review times pass between industry and FDA. One side claims the pathway to approval lacks transparency and predictability, the other claims the submissions are of poor quality. But could this coming year be the start of a new relationship between FDA and industry?

With this year coming to an end it’s time to look back and review the past year and start making the “to-do” list for the upcoming year. FDA has already taken this initiative and recently posted their Strategic Priorities for 2013. We’ve summarized the priorities and the planned steps to complete these proposals.