MDR reg effective date extension planned by FDA; baseline reporting changes likely.
This article was originally published in The Gray Sheet
MANUFACTURER MDR ANNUAL CERTIFICATION: EASING OF LANGUAGE is under consideration by FDA and likely will be included in the final version of the annual certification form for manufacturer medical device reporting. Speaking at a Feb. 7 session of a Regulatory Affairs Professionals Society meeting in Bethesda, Maryland, Chester Reynolds, associate director of the device center's Office of Surveillance and Biometrics, said that in response to industry concerns the agency is "discussing modifying the statement on the form" to make it less "absolute," and instead indicate all reportable events were submitted to the agency "to the best of [the manufacturer's] knowledge."
You may also be interested in...
Join us for a brief audio tour around the past week's key developments in the global biopharma industry, in this podcast version of Scrip's Five Must-Know Things.
The company will use the proceeds to fund clinical trials, expand commercialization of its targeted radiation therapy, and file for CE marking in Europe.
Advanced Medical Solutions said it will buy Raleigh Adhesive Coatings for £22m ($29m) in cash to strengthen its overall wound care business.