US FDA pilot aims for 30-day review of 510(k)s submissions for IVDs, radiology devices
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration has launched a six-month pilot programme under which it will aim to issue decisions on certain "good quality" pre-market notification (510(k)) submissions within 30 days, rather than its current standard of 90 days1.
You may also be interested in...
'Quik' Review Program Builds On US FDA eSubmission Efforts
The agency says 510(k)s submitted via an electronic template for any of about 40 product types might get a speedier review under a new pilot program.
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EMA Hopes New Requirement Will Make Companies Stick To Their Filing Plans
An additional form that marketing authorization applicants must now complete during the pre-submission stage emphasizes the importance of companies providing accurate information on their intended submission date.