After publishing the proposed regulation nearly two years ago, the FDA has issued its final rule that will make its regulatory framework more closely aligned with the international framework used by many other regulatory...more
A developing line of cases across the nation may have large implications for medical device manufacturers defending against failure-to-warn claims. While a treating physician’s failure to read or rely on the manufacturer’s...more
On March 14, 2022, a bipartisan trio of U.S. Senators introduced a bill (S.3830) that would require manufacturers to provide the tools and documentation necessary for consumers and third parties to repair electronic...more