Post-Approval Device Studies are investigations of safety and effectiveness of a particular medical device after it has been approved by the FDA, and after it has entered the clinical environment. To improve public access to this data, the FDA has just introduced the Post Approval Studies web page.
From the press release:
Modern devices provide significant health benefits, but 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. 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 of time.
Generally, 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.
FDA’s new Web page includes information on all post-approval device studies ordered by FDA since Jan. 1, 2005. Each listing includes the company’s name, the product’s 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. There are currently more than 40 listings on the Web page.
Press release: FDA Provides Web Access to Information on Post-Approval Device Studies …