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

UsernamePublicRestriction
UsernamePublicRestriction

FDA Cobbles Together Pilot For Remote Review Of Manufacturer Records

Executive Summary

The coming pilot program would give the US FDA remote access to a manufacturer’s records. It’s another approach the agency wants to try as it feels out the best way to virtually evaluate regulatory compliance during the COVID-19 pandemic.

You may also be interested in...



FDA Exploring Use Of Video – ‘Live Or Recorded’ – To Support Virtual Inspections During Pandemic

The US FDA is assessing via a pilot program whether the use of video is helpful when investigators perform remote facility inspections. Meanwhile, the agency’s device center is “working on alternative approaches for assessing a firm’s quality management system,” an FDA official says.

FDA Quietly Plots Pilot Program For Virtual Inspections As Pandemic Rages On

The COVID-19 pandemic is nudging the US FDA to launch a voluntary pilot program that will allow agency investigators to conduct facility inspections virtually, King & Spalding’s Steve Niedelman said on 11 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.

Topics

UsernamePublicRestriction

Register

LL1134882

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

Cancel