It has been highly anticipated that FDA was planning to issue a new proposed rule on laboratory developed tests (LDTs) with suggestions that a proposed rule could come in by the end of this week. The expectation clearly…Read More
September 29, 2023
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Month: September 2023
September 28, 2023
FDA Transition Plan in Action as Demonstrated by Akili EndeavorOTC Product
In March 2023, the FDA released a final guidance titled “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency“, which at high level set out a timeline…Read More
September 22, 2023
Commentary on Draft FDA Guidance titled “Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission”
On September 6th, 2023, the FDA released three draft guidances with the stated of goal of “…Part of Ongoing Efforts to Modernize the Premarket Notification [510(k)] Program”. I can not encourage industry and regulatory professionals enough to review…Read More
