On Health Policy Archives

Public Comment of the National Center for Health Research on USDA Proposed Rule on New Program on Natural Grass and Sod Products, Docket AMS-LP-21-0028

December 15, 2023: In response to a request for public comment, NCHR submitted a comment in support of the USDA proposed rule to establish a promotion, research, and information program for natural grass sod products. We believe this will provide important information that will help reduce the proliferation of artificial turf, which endangers the health of children and adults as well as harming the environment.

NCHR’s Comment on the ATF’s Proposed Rule on the Definition of “Engaged in the business”

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.

Patient, Consumer, and Public Health Coalition Comments Regarding the FDA Draft Guidance Recommendations for Evidentiary Expectations for 510(k) Implant Devices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.

Patient, Consumer, and Public Health Coalition Comments Regarding the FDA Draft Guidance Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions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.

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.