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

Abbreviated 510(k) program would shift work from ODE to FDA inspectors, agency staffers say.

This article was originally published in The Gray Sheet

Executive Summary

FDA'S ABBREVIATED 510(k) PLAN WOULD PUT BURDEN ON FIELD INSPECTORS to monitor manufacturers' compliance with standards cited in the premarket submissions, agency staffers say. Under the abbreviated 510(k) plan being developed by the agency, firms would be able to certify conformance of devices to relevant standards rather than submitting data covered by the standard as part of a 510(k) ("The Gray Sheet" June 23, p. 5). Data proving conformance would be kept in-house by manufacturers.
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT008998

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