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

Specific device indications 510(k) attachment added by FDA.

This article was originally published in The Gray Sheet

Executive Summary

SPECIFIC DEVICE INDICATIONS LISTING IN 510(k) CLEARANCE LETTERS "will reduce confusion between the agency and 510(k) submitters on which indications for use have been cleared," Philip Phillips, deputy director of the Center for Devices and Radiological Health's Office of Device Evaluation, says in a recent letter to device manufacturers. CDRH has begun clearing 510(k)s under a policy that requires sponsors to include in their premarket notifications a separate sheet "clearly" identifying "the indications for use for which a substantially equivalent determination is sought," along with the device name and the 510(k) number "if known."
Advertisement
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT005840

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