Senators Call for Medical Device Makers to Disclose Post-Market Safety Monitoring Procedures
U.S. Senators Charles Grassley, Richard Blumenthal and Herb Kohl have introduced the Medical Device Patient Safety Act, designed to give the Food and Drug Administration (FDA) tools to better monitor post-market performance of new medical devices.
Under the Act, if a medical device was approved under the expedited 510(k) process, “which now requires companies only to show their devices are smilar to those already on the market,” the FDA could require post-market studies to determine safety. The FDA could also grant partial device approval for devices approved under the 510(k) process, pending futher saftey studies.
In addition to introducing post-market safety legislation, the Senators have also sent investigative letters to five medical device manufacturers, requesting information on their post-market surveillance of products.
Senator Grassley’s press release states, “Letters were sent to Johnson & Johnson, for its DePuy metal-on-metal hip implant…Medtronic for its Infuse product; Boston Scientific for Guidant’s defibrillators; CR Bard for vaginal and hernia mesh products; and, Zimmer Holdings for its knee replacements.”