Medtech Insight is part of the Business Intelligence Division 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

IVD Data Integrity Concerns Are Increasingly 510(k)-Related

This article was originally published in The Gray Sheet

Executive Summary

In vitro diagnostic device 510(k) data will be getting a closer look from FDA, following a trend toward data integrity issues in premarket submissions
Advertisement

Related Content

Device Research Reg Compliance Trouble Spots Surveyed By BIMO Division
Device Research Reg Compliance Trouble Spots Surveyed By BIMO Division
Ventana Medical’s HPV Claims Probed By FDA In Vitro Diagnostic Office
Diagnostic Products Corp Is Second Device Firm Placed Under AIP In FY 2004
Diagnostic Products Corp Is Second Device Firm Placed Under AIP In FY 2004
Warning Letters Needed To Rein In Outlier IVD Practices – Attorney Kahan
Advertisement
UsernamePublicRestriction

Register

MT020150

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

Cancel