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

Misperceptions And Missteps: Schultz Speaks Out On CDRH Struggles

This article was originally published in The Gray Sheet

Executive Summary

Front-page criticism of FDA's device review process legitimately flags areas where the agency needs more work, though public misperceptions are also at play, says device center director Dan Schultz
Advertisement

Related Content

A Wild Ride Along The Total Product Life Cycle For Dan Schultz
A Wild Ride Along The Total Product Life Cycle For Dan Schultz
FDA Aims To Explain Itself Better With New Transparency Task Force
FDA Aims To Explain Itself Better With New Transparency Task Force
Do-Over? FDA Orders Look-Back At Knee Device 510(k) Review Process
Do-Over? FDA Orders Look-Back At Knee Device 510(k) Review Process
FDA Orders Firms To Submit Data For 25 Pre-Amendment Device Types

Topics

Advertisement
UsernamePublicRestriction

Register

MT027532

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