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

UsernamePublicRestriction

US FDA Pilot Programs Identified Need For Post-Market Benefit Awareness

Executive Summary

FDA pilot programs conducted before the issuance of a recent final guidance document on benefit-risk factors for post-market decisions found that the agency needed to work on questions used to evaluate the benefits of marketed products, an agency official said.

You may also be interested in...



CDRH’s New Post-Market Paradigm: Why The Public Should Be Worried

Strengthening the flow of real-world evidence on medical devices is at the heart of US FDA's evolving paradigm of device oversight. An underlying promise of the new approach is that a better post-market safety net will allow the agency's device center to take more risk in the pre-market phase, accelerating product development. But while safety surveillance is an important goal, the device center's recent actions and its April-issued Medical Device Safety Action Plan signal that it wants dramatic changes in its authority to decide how best to respond to perceived post-market safety signals, carrying potentially significant negative consequences for the public health, argues attorney Bradley Merrill Thompson in this guest column.

FDA Finalizes Post-Market Benefit-Risk Guidance

The guidance document attempts to help manufacturers and the agency consistently apply benefit-risk factors in making decisions about non-conforming products on the market and regulatory compliance issues. It is part of FDA’s larger effort to harmonize risk-benefit standards throughout the agency’s device center.

‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports

The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT104438

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