Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

CDRH Looks Ahead, And Behind, On Guidance Development

This article was originally published in The Gray Sheet

Executive Summary

The device center issued its standard "A list" and "B list" guidance priorities for fiscal year 2015, and unveiled plans to systematically reassess published guidance documents and seek technical feedback on future guidance topics.

You may also be interested in...



CDRH Sets Performance Goals To Reduce Draft Guidance Ambiguity

The device center has committed to metrics for draft guidance documents, trying to address complaints that policies linger too long in the draft stage and create regulatory confusion.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.

Clinical Labs Lawyer Up In Battle Over LDTs

ACLA has recruited Laurence Tribe and Paul Clement, two prominent constitutional legal guns with Supreme Court expertise, to fight FDA over its proposed lab-developed test guidance. The announcement is perhaps the lab industry's most high profile move yet to oppose FDA's plan to regulate lab-developed test services under the device statute with a risk-based phase-in plan.

Active Months Ahead For mHealth Regulatory Policymaking

Multiple guidances, frameworks and legislative activity on mHealth are expected to surface this fall and could have major implications on how the emerging industry is regulated.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT033884

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