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

Primary-Mode-Of-Action Rule For Combo Products Is Similar To Earlier Draft

This article was originally published in The Gray Sheet

Executive Summary

FDA's "primary-mode-of-action" 1final rule for combination products largely mirrors the language of last year's proposed version, although the agency adds clarification on various issues raised by stakeholders

You may also be interested in...



US Combo Product Designation Appeal Process Limited In Proposed Rule

Overhaul of reg on how combo products are designated to review centers eliminates the reconsideration appeal, but US FDA still allows appeals up the chain of command.

US Combo Product Designation Appeal Process Refined In Proposed Rule

In an overhaul of a regulation that sets out how US FDA designates combo products to product centers, the agency is proposing to update its policies so they align with current practices and mandates. FDA is also specifically proposing to streamline a designation appeal process that it says has been a burden for all parties.

Be Careful What You Ask For With Combo Product Designation Requests

Companies should carefully consider their moves for ensuring proper evaluation of combination product applications, including looking at whether a formal request for designation really is needed, say industry and legal experts.

Related Content

UsernamePublicRestriction

Register

OM007466

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