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


CDRH Sets Performance Goals To Reduce Draft Guidance Ambiguity

This article was originally published in The Gray Sheet

Executive Summary

The device center has committed to metrics for draft guidance documents, trying to address complaints that policies linger too long in the draft stage and create regulatory confusion. CDRH also highlighted recent website upgrades intended to better distinguish between draft and final guidance documents.


Related Content

Must-Do Guidance Development: What's On Tap From Cures, MDUFA IV
Illness Risk Fuels FDA Ban On Powdered Surgical Gloves
CDRH Guidance Priorities Include Lab-Developed Tests, Adverse Event Reporting, Third-Party 510(k) Review
Postmarket Device Surveillance Reforms Raised At Califf Confirmation Hearing
CDRH Can’t Rely On ‘Network of Experts’ Due To Confidentiality Concerns
CDRH Can’t Rely On ‘Network of Experts’ Due To Confidentiality Concerns
Industry Proposes Its FDA Guidance Priorities, Reforms
Draft Guidance Docs Should Be Transitory, Industry Insists
CDRH Looks For Input On Guidance-Development Practices
Is Draft Guidance More Than Meets The Eye? Senators Seek Answers From FDA





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