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

Device Trade Groups Offer Lukewarm Comments On Pre-RFD Draft

Executive Summary

BIO and AdvaMed offered multiple concerns about a January US FDA draft guidance formalizing the pre-RFD process, including that the timeline is too long and that the recommended information may not land manufacturers a center designation.

You may also be interested in...



Combo Product Consultations At US FDA May Suffer As They Become Formalized

Brad Thompson says that phone calls used in current informal process help sponsors understand Office of Combination Product’s thinking, and that a formalized process envision in the new draft guidance could make this dialogue more difficult.

Providers Asked To Use Fewer Blood Collection Tubes In Face Of Shortage

The US FDA is urging providers to conserve blood test tubes to combat an ongoing shortage. 

Device Center Promises Stronger Focus On Women’s Health

Women would be better represented in clinical research and device development under a new strategic plan from the US FDA.

Topics

UsernamePublicRestriction

Register

MT104755

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