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


Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

CDRH inspections database: Center launches 1database Sept. 30 of CDRH-led medical device inspections from 2008 to present. Inspections handled primarily by the Office of Regulatory Affairs are not included in the searchable database, so the database provides access to about 25% of device inspections conducted in the past two years. CDRH leads inspections of foreign facilities, as well as inspections related to Medical Device Reporting, labeling and software issues. The database can be found on the CDRH Transparency website. Clinical trial inspections are not included "because information about new medical device development is confidential," CDRH notes

Related Content





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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