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


CDRH FY 2000 Performance Goals Focus On Sponsor Meetings, Review Times

This article was originally published in The Gray Sheet

Executive Summary

FDA's Center for Devices and Radiological Health is pledging to hold 65% of premarket approval application "determination" and investigational device exemption "agreement" meetings within 30 days of a sponsor's request in fiscal 2000, FDA officials report.

You may also be interested in...

"Stratified" 510(k) Review Tracks Might Result From CDRH Resource Crunch

FDA's Center for Devices and Radiological Health is considering whether or not to "stratify" 510(k) submissions into "high-priority" and "low-priority" categories that would have different review timeframes, CDRH Director David Feigal said.

Administration's Device User Fee Bill Has Yet To Find Sponsor In Congress

FDA device user fee legislation developed by the Clinton Administration and recently submitted in draft form to Congress is "dormant" but not yet dead, officials in the Office of Management and Budget say.

Certain FDAMA Provisions Underutilized By Device Firms, Hill Aide Says

Manufacturers should be more aggressive in pressing for their rights under the FDA Modernization Act, Senate Labor and Human Resources Health Policy Advisor Jay Hawkins told the Regulatory Affairs Professionals Society Oct. 28 in Washington, D.C.

Related Content




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