In the evolving universe of multidistrict litigation, begun in the antitrust cases against major electronics manufacturers in the 1960s, federal courts have developed varying approaches to fulfilling their responsibilities to achieve efficiency and reduce costs. This process continues today almost 60 years since the creation of the first MDL. Read the Law360 article by Alan Klein and William R. Heaston on the Duane Morris website.
FDA Releases New Draft Guidance Documents to Modernize the 510(k) Process
On September 6, 2023, the FDA released three draft guidance documents that seek to “modernize” the 510(k) premarket notification process. Ever since the FDA first proposed “transformative new steps” to the program in 2018, the agency has promised to further update the 510(k) clearance pathway in an effort to better balance technological innovation and patient safety. In issuing these draft guidance documents, the FDA has followed through on that promise.
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