Schultz discussed the agency’s “total product lifecycle vision,” which—as the device industry is keenly aware—increasingly has begun to include post-market review and compliance initiatives during the past few years.

Though news about a final agreement among stakeholders on a reauthorized device user-fee program is expected any day now (though unavailable at press time), it remains unclear as to how post-market surveillance activities will be supported—if at all—by the renegotiated program. Despite this, the FDA has dedicated more resources to post-market surveillance.

As part of that effort, the FDA unveiled a new Web page in early April that will be updated monthly to keep the public and industry informed about the status of patient studies for certain recently approved medical devices. The site is a result of recommendations from the FDA’s Post-Market Device Transformation Leadership Team.

“Electronic access will give the public an opportunity to see progress being made on a company’s post-market commitments,” Schultz said following the Web site’s introduction.

According to the CDRH, “experience has shown that the full magnitude of some potential risks doesn’t always emerge during the mandatory clinical trials that are required for approval.” The FDA sometimes orders post-approval studies to address remaining issues such as the product’s performance once it becomes more widely available or is used over a longer period. Companies must submit interim post-approval study status reports every six months for the first two years of the study and annually thereafter until the final report has been submitted.

The Web page currently has more than 40 listings, and orthopedic devices currently under review include products from Biomet, DePuy, Kyphon, Smith & Nephew, Synthes and Zimmer.
The site includes information on all post-approval device studies ordered by the FDA since Jan. 1, 2005. Each listing includes the company’s name, product name, the approval number and date, and describes the study and whether it is meeting its reporting deadlines. No information on clinical data is available because the studies may be ongoing and include personal and confidential information. Industry trade groups have urged that no proprietary information on product intellectual property be made available.  

The Web site can be accessed via: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm.
    

Christopher Delporte
Group Editor