News: May 23, 2007
Registration of Clinical Trials at ClinicalTrials.gov Sees Considerable Expansion. According to a recent JAMA article, in the past two years the number of medical device trials registered at the government web site has increased from 121 to 1,631. The marked increase, particularly among medical device trial sponsors, is considered to be due in large part to medical journals' policies barring publication without registration via clinicaltrials.gov or a similar public web site. Additional information is available at www.thegraysheet.com (a subscription service).
Electronic Medical Device Reporting Set for Testing. The eMDR program, which aims to improve FDA's ability to identify the more critical adverse events reports from among the hundreds of thousands the agency receives each year, is slated to undergo testing. The program is currently open for voluntary participation, though participation is expected to mandatory in the future. Additional information is available at www.thegraysheet.com (a subscription service).
FDA Releases Two Clinical Trial Guidances. The first, a final guidance on computerized systems used in clinical investigations addresses the use of electronic data collection during a clinical trial and recommendations training, data security and protocols. The second is a draft guidance addressing the protection of human subjects. Additional information is available at www.thegraysheet.com (a subscription service).
Global Harmonization Task Force Issues Guidances to Standardize IVD Regulation. The two guidelines, based on previously released guidelines targeting medical devices generally, are specific to harmonization of in vitro diagnostics internationally. The guidelines propose four classes of devices, A through D, based on risk. Though non-binding, the guidelines may serve as a model for future developments in the regulation of these devices. The documents can be accessed at http://www.ghtf.org/whatsnew.htm.
User Fee Program Reauthorized by Senate. Under the Food & drug Administration Revitalization Act, the medical device user fee program was reauthorized, allowing FDA to collect $287 million in fees through 2012. Key aspects of the reauthorized user fee program are reduced fees for 510(k)s and PMAs, annual registration fees for all manufacturers, and more stringent performance goals. The bill will now go to the House for mark-up. Additional information is available at www.thegraysheet.com (a subscription service).
Comparative-Effectiveness Research Gaining Support. Legislation has been introduced in the House supporting studies comparing medical treatments in an effort to weed out ineffective and inappropriate care delivered in the U.S. and contributing to the current rate of health care spending. However, there is little consensus on how cost-effectiveness research and decisions should be folded into the current system. Additional information is available at www.thegraysheet.com (a subscription service).
First Respirators Intended for Public Use Cleared by FDA. The respirator masks are intended to be work during public medical emergencies to help reduce the user's exposure to airborne germs. The devices are manufactured by 3M and are designed for single-use. Additional information is available at http://www.fda.gov/bbs/topics/NEWS/2007/NEW01630.html.
FDA Classifies Gene Expression Profiling Test Systems for Breast Cancer Prognosis as Class II. The agency concurrently released a special controls guidance document describing compliance with the special controls to ensure the safety and effectiveness of the devices, and recommending validation of performance characteristics and product labeling. The guidance document is available at http://www.fda.gov/cdrh/oivd/guidance/1627.html.
FDA Reopens Comment Period for Proposed Rule to Reclassify Absorbable Hemostatic Devices from Class III to Class II. Comments will now be accepted through June 7. In addition, the agency will be accepting comments on the draft guidance document that would serve as the special control should FDA downclassify these products, which would allow them to be cleared via the 510(k) notification pathway rather than the PMA pathway. Additional information can be accessed at http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-8780.htm.