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

ASR Rulemaking Will Hinge On Risk Levels; AmpliChip Clarification Awaited

This article was originally published in The Gray Sheet

Executive Summary

Clarification on the regulation of microarrays as analyte-specific reagents likely will be provided in a letter from FDA to Roche Molecular Diagnostics within the next two weeks

You may also be interested in...



AmpliChip Microarray Could Take De Novo Premarket Route, FDA Tells Roche

Roche must submit a 510(k) application before commercializing its AmpliChip CYP450 microarray, FDA says in a letter clarifying its regulatory stance on the technology

AmpliChip Microarray Could Take De Novo Premarket Route, FDA Tells Roche

Roche must submit a 510(k) application before commercializing its AmpliChip CYP450 microarray, FDA says in a letter clarifying its regulatory stance on the technology

IVAT Proposal In Limbo As Industry Coalition Seeks Audience WIth FDA

Stakeholders are seeking clarification on agency concerns regarding industry's in vitro analytical test premarket proposal, following an Oct. 24 meeting between reps from OIVD and the IVAT industry coalition

Related Content

UsernamePublicRestriction

Register

OM014142

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