Medtech Insight is part of the Business Intelligence Division 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

'A Sea Change': Device Center Compliance Chief Touts US FDA's Benefit-Risk Concepts – But Will Manufacturers Buy In?

Executive Summary

FDA compliance head Robin Newman is asking manufacturers to share information on troublesome devices to help the agency make benefit-risk decisions that weigh product availability and regulatory compliance. But an industry survey finds that only 17% of firms are willing to hand over such potentially sensitive information. Nevertheless, the agency believes it's vitally important for device-makers to be more forthcoming with data that supports well-informed benefit-risk conclusions, made in the best interest of patients and manufacturers. Driving the data-sharing discussion is a December guidance from FDA that outlines a broad framework for considering benefit-risk factors – a document that Newman says is "a sea change" for how industry and the agency can work hand-in-hand on benefit-risk analyses.

Advertisement

Related Content

Benefit-Risk Is Front-And-Center In Latest Revision Of International Risk Management Standard ISO 14971
Chasing Quality Isn't Easy. But An FDA Pilot Aims To Boost Quality By Appraising The Capability Of Manufacturing Sites
FDA Sends Record-Low Warning Letters To Device-Makers In 2017 As Agency Takes More Personalized Compliance, Enforcement Tack
Compliance Corner: FDA Wants You To Take These 5 Actions After A Facility Inspection
'Program Alignment' Falls Into Place: Everything You Need To Know About US FDA's New Inspectional Approach
Warning Letter Nosedive: US FDA Writes Fewest Quality-Related Missives Since 2002; Agency Isn't Sure Why
FDA Finalizes Post-Market Benefit-Risk Guidance

Topics

Advertisement
UsernamePublicRestriction

Register

MT105272

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