CDRH Publishes Strategic Priorities for 2010

CDRH has published its 2010 Strategic Priorities. The four major identified priorities of CDRH include: fully implementing a total product life cycle approach, enhancing communication and transparency, strengthening the workforce and workplace, and facilitating innovation and addressing unmet public health needs. Within these priorities, CDRH has set forth a timeline, in which it states that it intends to begin implementation of the recommendations of the 510(k) Working Group by September 30, 2010. Director Jeffrey Shuren has indicated that he plans to review public comments from a meeting this month and the findings of an internal review, to be completed this summer, before making any proposals. In its notice announcing this month’s meeting on the 510(k) process, the FDA stated that it is seeking comments pertaining to four areas: predicate devices; new technologies and scientific evidence; practices for managing the high volume of 510(k) submissions; and post-market surveillance.

CDRH has also announced that it intends to launch a “Unique Device Identification” (UDI) system by Sept. 30, 2013.

FDA Moves Radiological Devices Branch to OIVD

FDA Commissioner Margaret Hamburg has signed orders to officially move the Radiological Devices Branch to the Office of In Vitro Diagnostic Device Evaluation and Safety, a result of long-term discrepancies between how in vitro and in vivo diagnostics have been regulated by FDA. OIVD will now house four product divisions – the division of chemistry and toxicology devices; immunology and hematology devices; microbiology devices; and radiological devices.

FDA Enforcement Letters on Marketing Campaigns Doubled in 2009

An FDA official has stated that the agency sent 41 enforcement letters in 2009 related to questionable drug-marketing campaigns, almost twice as many as it issued in 2008.

Mark Mansour is a partner in the firm, Bryan Cave, LLP