Bipartisan legislation that would require medical device manufacturers to track the performance of such products after they were approved for sale was introduced in the Senate yesterday, according to a New York Times report.
The bill would allow the FDA to require companies to track implants approved under the agency's 510(k) process that allows implants to be approved without human trials if they are "substantially similar" to previously approved implants. Such devices include hip replacements, which have been in the headlines recently for failing prematurely and leading to corrective surgery.
Although not requiring additional premarket testing of such devices, the bill would increase the FDA's post-approval oversight as well as tighten federal analysis of product recalls.
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The bill would allow the FDA to require companies to track implants approved under the agency's 510(k) process that allows implants to be approved without human trials if they are "substantially similar" to previously approved implants. Such devices include hip replacements, which have been in the headlines recently for failing prematurely and leading to corrective surgery.
Although not requiring additional premarket testing of such devices, the bill would increase the FDA's post-approval oversight as well as tighten federal analysis of product recalls.
Related Articles on the FDA:
FDA: Safety Labeling Changes Made to Prescribing Information for 48 Products in November
FDA Approves Intuitive Surgical's Single-Site Instrumentation for Gallbladder Surgery
FDA Issues Warning Letters to Surgery Centers and 1-800-GET-THIN on Lap-Band Advertising