The FDA is responsible for the safety of drugs, medical devices, food and cosmetics and has struggled to live up to the job over the last decade, especially in drugs and medical devices.
The GAO released a report (pdf) yesterday on FDA efforts to improve medical device safety. Ideally, device makers present evidence to the FDA that the product they want to sell is safe. Instead, many exploit the easier process for bringing devices to market by claiming the product they want to sell is “substantially equivalent” to one already on the market. The GAO has identified in recent years multiple FDA shortcomings in this area and has added FDA’s oversight of medical devices to its list of high-risk issues for the agency.
The new report finds that high-risk devices like artificial external defibrillators and implantable hip joints can still go to market through the less stringent oversight process, known as the “510(k)” process. Since 2009, “FDA has cleared at least 67 510(k) submissions that fall within these high-risk device types” the report says. The GAO also found that when device makers voluntarily recall their products, the FDA often has little idea whether the recalls are complete or sufficient.
Concludes the GAO: “Taken together, GAO’s preliminary work suggests that the combined effect of these gaps may increase the risk that unsafe medical devices could remain on the market.”