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

PMA Parallels

This article was originally published in The Gray Sheet

Executive Summary

Harvard cardiologist and device safety expert William Maisel sees a parallel "loophole" in FDA's model for assessing modifications to existing PMA products, which he says allows too many products on the market by means of a PMA supplement, which is less rigorous than a full PMA application.

You may also be interested in...



PMA Supplement Guidance Finally Finalized, But Questions Remain

FDA finalized guidelines Dec. 11 explaining what PMA supplement submissions are required for certain product modifications, largely mirroring 2007 draft guidance that device makers considered "incomplete.

P&G: Sales Growth Strongest When Rising Tide Floats All Competitors Across All Categories

P&G’s oral care business drove 35% of total category market growth in the firm’s fiscal 2020 and exemplifies its growth strategy for all segments – grow entire categories rather than take competitors’ market share, says CFO Jon Moeller.

COVID-19 Vaccine 'Brexit Bonus' A Myth

The Pink Sheet explains the procedures underpinning the UK’s emergency use authorization of the Pfizer/BioNTech COVID-19 vaccine.

Topics

UsernamePublicRestriction

Register

OM013133

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