In Vivo 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

IOL Myopia, Hyperopia Studies Should Include 3-Year Follow Up - FDA Panel

This article was originally published in The Gray Sheet

Executive Summary

Intraocular lens manufacturers pursuing approval for myopia and hyperopia indications should conduct 550-patient studies with three-year follow up, FDA's Ophthalmic Devices Advisory Panel concluded at an Oct. 23 meeting in Silver Spring, Maryland.

You may also be interested in...



Separate Phakic IOL Trials Recommended For Young, Old Patients

Refractive implant manufacturers pursuing claims for device implantation in phakic eyes - those with a natural lens - should conduct separate studies on younger and older patient populations to examine the risk of cataractogenesis, FDA's Ophthalmic Devices Advisory Panel recommended at a May 12 meeting.

QUOTED. 10 April 2020. Shawn Patterson.

3D-printing company Carbon and in vitro diagnostics maker Resolution Medical announced plans to manufacture more than one million 3D-printed nasal swabs per week to test for COVID-19. See what Resolution Medical’s president Shawn Patterson said about it here.

UsernamePublicRestriction

Register

MT010846

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