Medical device reporting
This article was originally published in The Gray Sheet
Medical device distributors that do not import are not required to submit MDR reports or supplemental reports under an FDA final rule effective March 27. Distributors must still maintain device records, such as complaint files, for the expected lifetime of each product or a minimum of two years, despite a recommendation from a congressional conference committee that recordkeeping requirements be limited to six years
You may also be interested in...
Previous businesses FDA warned about COVID-19 claims for chlorine dioxide, a bleach solution, were marketing dietary supplements unlawfully. But Pro Breath MD's oral rinses available under the Dentist Select and OraCare brands are allowed and FDA isn’t asking the firm to discontinue distribution.
The Stark Law ban on self-referrals wouldn’t apply to some physician owners of advanced imaging facilities under a CMS final rule.
Pfizer’s abrocitinib and Biogen/Eisai’s aducanumab are among a host of new investigational products that are under review by the European Medicines Agency.