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

PMA Average Review Times Flat In FY 1999; 510(k) Times Fall 10%

This article was originally published in The Gray Sheet

Executive Summary

FDA's Center for Devices and Radiological Health pruned average review times for 510(k) applications by roughly 10% to 74 days in fiscal year 1999 (ended Sept. 30) compared to 82 days in the previous fiscal year, according to the center's unofficial tally.

You may also be interested in...



CDRH Director To Serve As Acting ODE Director; Alpert Joins FDA Food Center

FDA Center for Devices and Radiological Health Director David Feigal will serve as Office of Device Evaluation acting director on an interim basis following the scheduled departure of Susan Alpert from the position.

CDRH Director To Serve As Acting ODE Director; Alpert Joins FDA Food Center

FDA Center for Devices and Radiological Health Director David Feigal will serve as Office of Device Evaluation acting director on an interim basis following the scheduled departure of Susan Alpert from the position.

Rochester Medical FemSoft Incontinence Insert Among FY 1999's 33 PMAs

FDA approval of Rochester Medical's FemSoft insert for female stress urinary incontinence on Sept. 30, the final day of the federal government's fiscal year, apparently put the agency's total number of approved, original premarket approval applications for the year at 33, down from 42 in 1998 and 46 in 1997.

UsernamePublicRestriction

Register

LL1134478

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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