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

New Metrics For Clinical Trial Oversight Floated By CDRH Entrepreneurs In Residence

This article was originally published in The Gray Sheet

Executive Summary

Variability runs high in FDA’s process for approving new device trials, but the agency is open to recommendations for improvements coming out of its entrepreneurs-in-residence program, says Chip Hance, a former Abbott executive participating in the program.

You may also be interested in...



CDRH Focusing On New PMA Pathway, Clinical Trials Program In 2014/2015 Priorities

CDRH Director Jeffrey Shuren discussed the device center’s two-year strategic priorities with “The Gray Sheet.” The center plans to rebalance pre-market and post-market data collection, when appropriate, and improve the processes for starting up clinical trials in the U.S.

CDRH Focusing On New PMA Pathway, Clinical Trials Program In 2014/2015 Priorities

CDRH Director Jeffrey Shuren discussed the device center’s two-year strategic priorities with “The Gray Sheet.” The center plans to rebalance pre-market and post-market data collection, when appropriate, and improve the processes for starting up clinical trials in the U.S.

CDRH’s Shuren Signals More Guidance, Enhanced Pre-Market Payer Role

CDRH Director Jeffrey Shuren details plans for new guidance documents and process changes at the device center, focused on IDE reviews, clinical testing requirements and pre-submission interactions with payers based on recommendations from the center’s entrepreneurs-in-residence program.

Related Content

Topics

UsernamePublicRestriction

Register

MT032065

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