July 5, 2022: This proposed draft guidance on Fostering Medical Device Improvement aligns closely with the needs of medical device companies, but not with the needs of patients and consumers. NCHR has many concerns about the proposed program.
Read More »Tag: medical device
More efficacy data needed for Levo’s PWS treatment
BioWorld, November 4, 2021: Prader-Willi syndrome (PWS) is a terrible disease. But Levo Therapeutics research evidence for their nasal spray to prevent uncontrollable eating is among the worst we’ve seen at National Center for Health Research.
Read More »NCHR’s Comments to FDA on the Remanufacturing of Medical Devices
September 22, 2021: We agree with the FDA that clarification is needed of whether or not activities performed on medical devices are considered “remanufacturing” or “servicing,” and we support the draft guidance’s clarity on how to correctly classify a procedure.
Read More »