Breaking news alert reprinted from "The Gray Sheet" - January 20, 2010
CDRH Taps Shuren As Permanent Head, Sets Ambitious 2010 Agenda
FDA named Jeffrey Shuren as permanent device center director today, while launching an ambitious 2010 agenda that includes changes to the 510(k) and PMA pre-market programs by this fall, harmonized international inspection activities by 2011 and unique device identification by 2013.
The Center for Devices and Radiological Health released its FY 2010 "strategic priorities" report on Jan. 20, and also appointed acting director Shuren as official CDRH director.
Shuren, the former associate commissioner for policy and planning in FDA Commissioner Margaret Hamburg's office, was appointed interim director Sept. 2 after former center head Dan Schultz resigned.
The CDRH report identifies four priority areas for the coming year: fully implement a total product life cycle approach; enhance communication and transparency; strengthen the CDRH workforce and workplace; and spur innovation and address unmet public health needs.
Within these, CDRH set several goals with clear and aggressive deadlines; the center says it will be able to accomplish many of them this fiscal year.
Chief among these will be implementing, by Sept. 30, the recommendations of an internal 510(k) working group that was charged with strengthening the 510(k) program.
CDRH also says it will begin taking action steps at the end of November to improve the quality of clinical data submitted as part of PMA applications through draft guidance and other measures. Recent reports published in medical journals raised questions about the quality of the clinical data that FDA accepts to support PMA approval.
- Jessica Bylander ([email protected])
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