FDA 510(k) EXEMPTION OF 62 CLASS II DEVICES ON JAN. 21 BRINGS TOTAL TO 636; RULE INCLUDES 30 IVDs, BUT DOES NOT APPLY TO POINT-OF-CARE TEST SYSTEMS
This article was originally published in The Gray Sheet
Executive Summary
FDA exemption of 62 Class II devices from 510(k) review in a Jan. 21 final rule brings to 636 the total number of products that no longer require premarket evaluation. The final rule was published two days after the 60-day deadline stipulated in the FDA Modernization Act, which was signed into law Nov. 21.
You may also be interested in...
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.
Vivalink Partners With Rett Syndrome Research Trust To Accelerate Research In Rare Disease
Vivalink will provide ECG wearable technology to monitor patients in RSRT’s Vibrant study, which is aimed at assessing autonomic dysfunction in children with Rett syndrome.
Cidara Offloads Rezzayo, Will Focus On Universal Flu Preventative
Cidara conferred global rights to its novel antifungal to marketing partner, Mundipharma, while reacquiring a flu prophylaxis it licensed to J&J in 2021 and gaining $240m in new funding to back development.