Medical Devices Law BlogFDA Requires Additional Vaginal Mesh Studies According to a recent article by Businessweek, The U.S. Food and Drug Administration wrote a letter to 33 vaginal mesh manufacturers, including Bard and Johnson & Johnson, requiring that the companies study the potential vaginal mesh complications and rates of organ damage. The agency requested... Read More at the Medical Devices Blog Controversial FDA 501 (k) Approval Process In light of the recent U.S. Food and Drug Administration warnings about vaginal mesh and potential problems associated with other medical devices, the approval process has come under scrutiny. Currently, the FDA 501 (k) approval process clears newly developed or manufactured medical devices with... Read More at the Medical Devices Blog |
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The manufacturing, repackaging, re-labeling and importation of medical devices is regulated by the Center for Devices and Radiological Health (CDRH), a department of the Federal Food and Drug Administration (FDA). All medical devices sold in the United States are classified according to the level of precision required to operate the device safely and effectively. Reports on devices which have malfunctioned or caused death or serious injury are collected by the CDRH and stored in the Medical Device Reporting (MDR) database and the Manufacturer and User Facility Device Experience (MAUDE) database. Please choose a legal issue for more:
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