Medtech Insight is part of the Informa 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

SINGLE-SITE PRK STUDIES ADVOCATED BY FDA FOR MODIFIED, UNAPPROVED LASERS; FDA AUTHORITY OVER PHYSICIAN-MODIFIED LASERS UNCLEAR, ODE's BROGDON SAYS

This article was originally published in The Gray Sheet

Executive Summary

Ophthalmic surgeons that perform photorefractive keratectomy with lasers not labeled for the vision correction procedure can obtain FDA approval of the devices on a single-site, single-laser basis, Morrix Waxler, a reviewer in the Division of Ophthalmic Devices in FDA's Office of Device Evaluation, said at an April 1 meeting of FDA's Ophthalmic Devices Panel in Gaithersburg, Maryland.
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT005762

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