Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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


Guidances Outline PMA Review Process For Manufacturing, Clinical Sections

This article was originally published in The Silver Sheet

Executive Summary

TWO DRAFT GUIDANCES RELEASED BY FDA provide timetables for the agency’s review of the quality systems and clinical data portions of premarket approval submissions, and also aim to ensure that manufacturers are prepared for PMA pre-approval manufacturing and clinical trial inspections. CDRH Director Tim Ulatowski explains that the guidances will help the center meet time goals set forth in the Medical Device User Fee & Modernization Act. He says the documents "make it clear to center staff and to headquarters and field staff that these goals are important, that there are timeframes that need to be met." Meanwhile, approximately 15% of companies usually aren’t ready for their pre-approval inspections, Ulatowski says, pointing out that the rate has been as high as 50% at various times... GUIDANT’S PROBLEMS RUN DEEPER THAN COMMUNICATION ISSUES, according to Boston Scientific’s CEO, who says it could take up to two years for the company to address underlying design and production problems with Guidant’s ICDs and pacemakers...

You may also be interested in...

Warning Letter Roundup & Recap – 1 December 2020

In the only device-related warning letter released by the US FDA this week, Avazo Healthcare was selling two COVID-19 antigen tests without approval, clearance or authorization from the agency.

On-Site Inspections Of US Device Makers Plummet 93% As FDA Scrambles For Virtual Solutions

A sharp decline in the number of in-person facility inspections has forced the FDA to consider creative techniques for remotely evaluating manufacturer compliance during the COVID-19 pandemic. This and other stories topped our list of most-read Medtech Insight articles in November.

ASTM Developing Standard To Tackle Dried Blood On Steel Devices

ASTM International is proposing a new standard that will provide a cleaning agent formula for removing dried blood from stainless steel medical devices.





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