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

The Meaning Of 'Accurate': Debate Continues With Latest CLIA Waiver Guidances

Executive Summary

Accuracy "is a widely used and generally understood term in clinical laboratory sciences," according to US FDA, but industry groups say the agency continues to misunderstand Congress' use of the word when it comes to CLIA waivers for point-of-care tests, including in a draft guidance document issued by the agency in recent days. FDA is also touting a new, more efficient approach to dual 510(k)-CLIA waiver submissions. 

You may also be interested in...



CLIA Waiver Study Guidelines Simplified By US FDA In Latest Revisions

FDA took the unusual step of issuing a second round of draft guidance documents in its effort to refine requirements for diagnostics companies seeking a CLIA waiver to allow point-of-care use of a test. The revised drafts are simplified compared to November 2017 versions, and they appear to line up more closely with industry arguments about what is needed to demonstrate "accuracy" in this context.

Dx Departure: US FDA's Diagnostics Chief Gutierrez Steps Down

Alberto Gutierrez left FDA and government this week in a planned retirement. He was director of the office that oversees pre- and post-market programs for in vitro diagnostics and radiology devices, an office where several holes already exist in top management slots.

21st Century Cures: Device Provisions

Dozens of reforms impacting the medtech sector were signed into law Dec. 13 as part of the 21st Century Cures Act. Here's a breakdown of the provisions most important to device- and diagnostic-makers.

Related Content

UsernamePublicRestriction

Register

MT121874

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