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


IVD Reps Propose Alternative 510(k) Route For In Vitro Analytical Tests

This article was originally published in The Gray Sheet

Executive Summary

An IVD industry proposal to foster a new 510(k) mechanism for innovative analyte test kits would offer a timely alternative to "homebrew" diagnostic tests

Related Content

Manufacturers’ Group Is Not Satisfied With FDA In-Vitro Diagnostics Office
AdvaMed Reworks ASR Language In Hopes Of Influencing New FDA Guidance
AdvaMed Seeks To Raise Diagnostic Sector Profile, Improve Test Payments
IVD Manufacturers, Labs Should Be Subject To Same Standards – AdvaMed
A Brewing Debate? ASR Reg Eyed As CMS Readies For Genetic Test Rule
IVAT Proposal In Limbo As Industry Coalition Seeks Audience WIth FDA
ASR Rulemaking Will Hinge On Risk Levels; AmpliChip Clarification Awaited
Roche ASR Marketing Approach For AmpliChip Microarray Draws FDA Scrutiny
QS Initiative Gains Significance In 2003 Budget Crunch – McClellan
QS Initiative Gains Significance In 2003 Budget Crunch – McClellan



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