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The F.D.A.’s Medical Device Problem
The Food and Drug Administration (FDA) has been regulating the approval of medical devices since 1976, but its regulatory oversight has not kept pace with the increasing complexity of this technology. Many high-risk medical devices today are approved on the basis of just one clinical trial (as opposed to new medications, which usually require two trials). And only a small minority of clinical studies of medical devices are randomized, controlled and blinded — the gold standard for reliable evidence (and the benchmark to which studies of drugs are held).
As a result, there have been many warnings about, and recalls and withdrawals of, medical devices that were found to be dangerous only after they were on the market.
Incredibly, legislation that the House of Representatives passed in July 2015 would severely weaken, not strengthen, the F.D.A.’s already ineffective regulatory scheme for medical devices. The legislation, disingenuously titled the 21st Century Cures Act, would make it possible for companies that produce high-risk medical devices to submit evidence of safety and efficacy based on sources other than clinical trials, including case histories (i.e., the experiences of individual patients). Read more here.
Last modified: Wed, 05 Aug 2015 13:00:52 BST