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


Final Combo Product GMP Requirements Are More Of The Same; Encourage FDA Meetings

Executive Summary

A recent Federal Register Notice on GMP requirements for combination products doesn’t change any of the fundamental expectations and requirements laid out in a previous 2018 draft, but does add clarification for sponsors.

You may also be interested in...

More Guidance Coming On Common Combo Product Designation Mistakes

US FDA's Office of Combination Products hopes Q&A guidance will help lower high refusal rate on requests for designation.

'Combination Product Agreement Meetings' Coming Soon From US FDA

The meetings are tied to requirements from the 2016 21st Century Cures legislation. They could offer more development certainty for sponsors by allowing informal agreements with the agency on pre- and post-market issues.

Novel Negative Pressure Wound Therapy System Cleared By FDA

The FDA granted 510(k) clearance to Applied Tissue Technologies for its non-foam negative pressure wound therapy system. 


Latest News
See All



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