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

OPHTHALMIC DEVICE STANDARDIZED CLINICAL STUDY PROCEDURES

This article was originally published in The Gray Sheet

Executive Summary

OPHTHALMIC DEVICE STANDARDIZED CLINICAL STUDY PROCEDURES will be presented by FDA to the agency's Ophthalmic Devices Panel at the Jan. 26 meeting, according to FDAers. The standard operating procedures (SOPs) were agreed upon by representatives from industry, academia, FDA and the National Institutes of Health at the Dec. 1-2 eye care technology forum at the NIH campus in Bethesda, Maryland. The forum participants agreed on SOPs for measuring visual acuity; intraocular pressure and visual fields. Testing contrast sensitivity was also discussed, but the forum failed to reach a consensus on the issue.
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT003193

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