The manufacturers of 25 medical devices that have been on the market since before 1976 -- including certain pacemakers, defibrillators, spinal screws, and prosthetic hip joints -- will need to demonstrate that their products are still safe and effective, the U.S. Food and Drug Administration announced today.
The medical devices covered under today's FDA announcement hit the market prior to passage of the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976, which gave the FDA the authority to review and regulate new medical devices.
Under that law, according to the New York Times, "Congress instructed the F.D.A. to gradually reclassify these older devices and decide which ones needed extensive testing prior to approval of new versions and which ones did not." The 25 devices that are subject to today's FDA order represent the final batch of "Class III" medical devices that still need review.
According to the FDA, "Class III devices represent the highest level of risk and generally require a showing of safety and effectiveness before they may be marketed," so today's action seeks to complete some unfinished business related to the safety of medical devices that have been around for decades.
Once the manufacturers submit their respective products' safety and effectiveness information to the FDA, the agency will review the data, assess the risk level to patients, and then issue regulations for each device. The review will likely show that either 1) An older device represents an unacceptable risk, so manufacturers will need to re-initiate the medical device approval process under the post-1976 standards, or 2) an older device represents a lower risk and will be re-classified accordingly.
- FDA to Review Medical Devices Marketed Prior to 1976 (FDA.gov)
- FDA's Notice to Medical Device Manufacturers in the Federal Register (FederalRegister.gov)
- N.Y. Times: FDA to Seek New Proof for Old Medical Devices
- Reuters: U.S. FDA Demands Data on Older Medical Devices
- Medical Product and Device Defects (FindLaw)
- Product Safety Cases - Legal Issues (FindLaw)
- Responsible Parties in Medical Malpractice Actions (provided by The Law Offices of J. Neal Rodgers, PLLC)