Full article reprinted from "The Gray Sheet" - January 25, 2009
CDRH launched an ambitious 2010 agenda Jan. 20 that includes changes to the 510(k) and PMA pre-market programs by this fall, harmonized international inspection activities by 2011 and unique device identifiers by 2013. Read more...
Shuren's CDRH Sets Ambitious 2010 Agenda: 510(k), PMA Changes Planned
Full article reprinted from "The Gray Sheet" - January 25, 2009
CDRH launched an ambitious 2010 agenda Jan. 20 that includes changes to the 510(k) and PMA pre-market programs by this fall, harmonized international inspection activities by 2011 and unique device identifiers by 2013.
The Center for Devices and Radiological Health released its FY 2010 "strategic priorities" report in conjunction with Jeffrey Shuren's ascension from acting to permanent CDRH director.
The CDRH report identifies four priority areas for the coming year: to fully implement a "total product life cycle" approach; to enhance communication and transparency; to strengthen the CDRH workforce and workplace; and to spur innovation and address unmet public health needs.
Within the four priority areas, CDRH set several goals with specific 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 working group that is charged with strengthening the 510(k) program (The Gray Sheet' Oct. 5, 2009).
Spotlight On 510(k) And PMA Improvements
The agency has conceded that the 510(k) program needs improving and has already taken steps in that direction, including forming the working group and contracting with the Institute of Medicine to perform an independent assessment of the program.
To finalize its 510(k) recommendations, the internal working group will first seek input through a public meeting and comments docket on Feb. 18, and from an all-hands CDRH staff meeting by March 31.
Also by the end of March, the center plans to update its 510(k) quarterly quality review program so it can assess the impact of reforms to the 510(k) paradigm.
The 510(k) working group will send recommendations to Shuren at the end of May, and set an implementation plan by the end of July, the report says.
Further, CDRH plans to complete its evaluation of the IOM report, due in March 2011, by June 2011.
In 2010, the center also plans to address the issue of Class III device types that currently enter the market via the 510(k) process. CDRH has already taken steps to close the regulatory loophole that has exempted certain device categories from PMA requirements for the past 30 years without full assessment of the appropriate oversight for the products (The Gray Sheet' Aug. 17, 2009).
In large part, the goals set out in the strategic report address a laundry list of recent criticisms of CDRH operations.
In addition to concerns about the rigor of the 510(k) process, recent reports in medical journals have also raised questions about the quality of the clinical data that FDA accepts to support PMA approval (The Gray Sheet' Jan. 18, 2010).
In the strategic report, CDRH says it will improve the quality of clinical data submitted in PMAs through draft guidance on PMA study designs and other measures. The center intends to begin taking action steps by the end of November.
Big Goals: UDI, Transparency, Dispute Resolution
The report outlines more than 25 "total product lifecycle" goals, including hiring deputy center directors for science and for policy by March 31 (The Gray Sheet' Dec. 21, 2009); improving adverse event reporting processes; better harmonizing regulatory practices with other countries; improving guidance and regulation development; and moving closer toward a mandatory unique device identifier program.
CDRH says it will complete a new phase in its UDI database pilot project by this September, and will implement the full UDI system by the fall of 2013.
The center also says it will create a center-wide strategic risk communication plan by this fall and launch a transparency Web site at the end of January. FDA already has an agency-wide blog and public docket for transparency issues.
CDRH also plans to issue revised draft guidance on resolving differences of opinion between outside parties and CDRH, according to the strategic report.
On the innovation front, CDRH says it will work with other federal agencies to identify the five most important unmet public health needs and facilitate development of devices to meet those needs.
By July, the center will hire a dedicated "medical device innovation coordinator," as well as allow other key agency staff to devote part of their time to focusing on device innovation.
The center also plans to identify two device types that have been associated with repeated safety problems, and this fall will announce ways to address the problems through device design improvements, the report says.
- Jessica Bylander
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