REAGENTS GUIDANCE EASES 510(k) RULES FOR OEM REAGENTS USED WITH MODIFIED ANALYZERS, SECONDARY REAGENTS FOR MULTIPLE SYSTEMS; EFFECTIVE DATE JUNE 17
This article was originally published in The Gray Sheet
Executive Summary
Premarket notification submission requirements for many in vitro diagnostic reagent manufacturers will be considerably reduced under an FDA guidance that goes into effect June 17. The document, called "Data for Commercialization of Original Equipment Manufacturer, Secondary and Generic Reagents for Automated Analyzers," was released June 10.
You may also be interested in...
Alvotech Highlights Lack Of Simponi Rivals As It Delivers Golimumab Results
Alvotech has just become the first company to announce positive topline results from a confirmatory clinical study for a proposed golimumab rival to Simponi and Simponi Aria – and moreover, the firm sees limited competition from other biosimilars on the horizon.
Xbrane Assembles The Troops As FDA Says No To Lucentis Biosimilar
Xbrane Biopharma was riding the crest of a wave with the EU launch of its biosimilar to Lucentis, following years of toil and investment. However, plans to roll out the product in the US will have to be pushed back – likely – into the middle of 2025, following a US FDA complete response letter.
UK MHRA Updates Assistive Tech And Borderline Regulations
Device classification themes were uppermost in April for the UK regulator, which issued key guidance in two areas prone to complexities. It also contributed to the MedTech Directorate’s one-year progress report.