Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Sen. Markey Applauds CDRH Database Improvements

This article was originally published in The Gray Sheet

Executive Summary

The Democratic senator from Massachusetts, highly critical of the potential for a device to be FDA-cleared with a predicate that has been recalled for safety issues, says he supports recent changes made by FDA’s device center to its recalls, 510(k) and PMA databases.

You may also be interested in...

Regulatory Briefs: UDI Guru Crowley Heads To Industry; Reclassification Website; Post-Market Planning Board

Jay Crowley, the principle architect of FDA’s UDI regulation, is leaving the agency. FDA announced the launch of a website tracking the reclassification of device types, the accreditation GS1 as a UDI issuing agency and improvements to its device recalls database. More regulatory news.

Regulatory News In Brief

Regulatory news updates form the Hill, industry and FDA.

Markey Bill Would Bar 510(k) Clearances Of Devices With Recalled Predicates

Sponsors say the bill “closes a significant loophole that currently puts patients at serious risk of debilitating injury by ensuring that devices do not mimic the mistakes made by other products.”


Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts