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


CDRH Prioritizes Leveraging Real-World And Patient-Preference Data, Enhancing Quality

This article was originally published in The Gray Sheet

Executive Summary

In its 2016-2017 strategic priorities, the device center lays out specific goals for putting more emphasis on real-world postmarket data to support regulatory decisions, making better use of patient-preference input, and enhancing quality at CDRH and in industry. Topping FDA's list: gaining access to 25 million electronic patient records with device identification from global registries, insurance claims data and electronic health records, and expanding that number to 100 million by the end of 2017 to support premarket and postmarket decisions.


Related Content

The Patient Perspective: Upcoming US FDA Device Center Studies Put Device-Users In Front Seat
Industry Urges Caution In Response To Growing Push For 'Real-World' Device Evaluation System
Industry, FDA Outline Costs Of New MDUFA Proposals; Quality Management A Strong Focus
TOPAS Fecal Incontinence Device Gets Unanimous Support For Approval At FDA Panel
Commissioner Califf: Cardiologist, Clinical Trials Expert Ascends At FDA
Task Force Advocates Making Registries Better Than Sum Of Their Parts
Guidance: What The Patient Prefers, And How To Make It Part Of Your FDA Submission
Device Consortium Tries To Shed Light on Patient Risk-Benefit Preferences
Planning Board Proposes Postmarket Device Surveillance Timeline
FDA Weighs Patients' Risk Tolerance in Approving Obesity Device


Related Companies




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