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

In-Vitro Diagnostics Should Be Eligible For Third-Party Review - Industry

This article was originally published in The Gray Sheet

Executive Summary

FDA should identify more in-vitro diagnostics for inclusion in the agency's "Accredited Persons" third-party premarket review program, DiaSorin VP Regulatory Affairs and Quality Systems, Judith Smith recommended.

You may also be interested in...



DiaSorin Hepatitis B Tests Need Clearer Indication Of "High-Risk" Population

DiaSorin needs to distinguish between specific subgroups of high-risk patient populations in labeling of its ETI Plus line of in vitro diagnostic hepatitis B serological marker assays, FDA's Microbiology Devices Advisory Panel agreed in recommending six assays for approval at a Jan. 20 meeting in Rockville, Maryland.

DiaSorin Hepatitis B Tests Need Clearer Indication Of "High-Risk" Population

DiaSorin needs to distinguish between specific subgroups of high-risk patient populations in labeling of its ETI Plus line of in vitro diagnostic hepatitis B serological marker assays, FDA's Microbiology Devices Advisory Panel agreed in recommending six assays for approval at a Jan. 20 meeting in Rockville, Maryland.

FDA's Third-Party Review Program: Quick Review Times, Low Volume

Third-party 510(k) submissions are gaining FDA clearance at over three times the rate of comparable submissions made directly to the agency, Eric Rechen, a staffer in FDA's Office of Device Evaluation, said.

UsernamePublicRestriction

Register

LL1135009

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