December 5, 2023: NCHR supports the ATF’s proposed rule that will implement an updated definition of “engaged in business” so that anyone engaged in selling firearms “for profit” will be deemed as sellers required to do background checks on their patrons. This new rule will require trade shows and online retailers to be regulated the same as brick-and-mortar establishments.
Read More »Author: Caroline Bradford
FDA Warned of Overstepping Authority With Lab Test Rule Proposal
Bloomberg Law, December 7: Bloomberg Law news article describes the strong opposition to FDA’s plan to regulate lab-developed tests (LDTs). We explain why patients can’t trust the results of these diagnostic tests unless FDA makes sure they are accurate.
Read More »Patient, Consumer, and Public Health Coalition Comments Regarding the FDA Draft Guidance Recommendations for Evidentiary Expectations for 510(k) Implant Devices
December 6, 2023: In its public comment, members of the Patient, Consumer, Public Health Coalition urged FDA to institute stronger standards to determine clinically meaningful substantial equivalence for 510(k) clearance.
Read More »Patient, Consumer, and Public Health Coalition Comments Regarding the FDA Draft Guidance Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions
December 6, 2023: In its public comment, members of the Patient, Consumer, Public Health Coalition urged FDA to rely more on scientifically credible types of clinical data for 510(k) to ensure patients’ health and safety.
Read More »Patient, Consumer, and Public Health Coalition Comments to FDA on their Guidance for Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission
December 6, 2023: In its public comment, members of the Patient, Consumer, Public Health Coalition told FDA that if a predicate device for 510(k) review does not align with the best practices identified in the FDA guidance, the device should be submitted to De novo or PMA instead.
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