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

FDA Issues Long-Planned Draft Guidance On Functional Indications For ICDs

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers who wish to describe the benefits of ICDs in a particular patient population in the device labeling must submit a PMA supplement to FDA with supporting data, according to a 1draft guidance

You may also be interested in...



ICD Function, Patient Population Claims Will Be Clarified By CDRH Guidance

FDA is crafting a "functional indications" policy to help agency staff and implantable cardioverter defibrillator manufacturers clarify the devices' intended patient population

ICD Promotion For New Indications May Not Need PMA Supplements - FDA

FDA would still need to consider on a case-by-case basis whether a premarket approval application supplement would be required for manufacturers to promote new indications for implantable cardioverter defibrillators (ICDs) under the agency's proposed labeling change for the devices.

Dr Reddy's Adds To OTC Portfolio With Glenmark Deal

Dr Reddy's is poised to expand its OTC offering in Russia and certain CIS countries by snapping up a basket of allergy brands from fellow Indian firm Glenmark.

UsernamePublicRestriction

Register

LL026487

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