Bill Would Require More Monitoring of Implants (NY Times)
Amid growing problems with artificial hips and other medical implants, bipartisan legislation was introduced in the Senate on Wednesday that would force manufacturers to track the performance of such products after they were approved for sale.
The bill would allow the Food and Drug Administration to compel companies to track implants, such as replacement hips, that belong to a category of products that do not require human testing for approval.
The proposal is an effort to address longstanding complaints by patient advocates and others like the Institute of Medicine about a system known as the 510(k) process that the F.D.A. uses to clear the sale of certain implants like artificial joints. To sell a new product under that system, a producer need only show that it is “substantially similar” to a product already on the market.
Thousands of the all-metal hips that are now failing prematurely in patients were approved through the 510(k) system. The new proposal would not require added premarket testing of such implants but would broaden the F.D.A’s postapproval oversight by giving it the authority to mandate that compa...
