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 Final Guidance: No Corrections And Removals Reports For Device Enhancements

This article was originally published in The Silver Sheet

Executive Summary

Online-Only Content >>> CDRH clarifies that Part 806 recall reports are not necessary for actual device enhancements that do not qualify as a correction or removal.

You may also be interested in...



Device Makers To FDA: Recall The Recalls Draft Guidance

The draft guidance is an attempt by FDA to reassure companies that they can make an enhancement to a marketed device without worrying that the action will be perceived as a recall. But the effort appears to have increased, rather than alleviated, industry anxieties.

Big Pharma BD Execs Tell Start-Ups: Don’t Be Afraid To Ask Us For Help

Business development leaders and venture capital investors spoke at Biocom’s annual partnering conference about what they are seeking in relationships with entrepreneurs and start-ups.

Transformation Into Viatris Not Seen As The Solution Mylan Needs

Mylan’s full year 2019 earnings report was its last as an independent company, so the focus was on the coming merger with Pfizer’s Upjohn and growth prospects for the new company, Viatris.

Topics

UsernamePublicRestriction

Register

MT036824

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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