US FDA to make targeted revisions to 510(k) modifications guidance
This article was originally published in Clinica
The US FDA intends to retain the foundation of its 1997 guidance on 510(k) medical device modifications and instead make targeted revisions to the document, the agency has said in a report to Congress that spells good news for the industry.
You may also be interested in...
A combined final opinion on the European Chemicals Agency’s proposed microplastic restriction is expected from ECHA committees by year-end, at which point the European Commission will consider whether and when microplastic must be removed from all leave-on cosmetic products marketed in the EU.
Butterfly Network’s CEO Laurent Faracci outlines the company’s growth strategy and plans for their “ultrasound-on-a-chip” technology after its merger with blank check company Longview Acquisition Corp. See what the company’s CEO said about it here.
CDC’s Advisory Committee on Immunization Practices votes 13-1 that these two groups be first in line for vaccination once FDA authorizes a vaccine and ACIP recommends it. Goal of vote is to guide health departments in placing vaccine orders.