Pink Sheet 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

In Brief: Contact lens accessory downclassification

This article was originally published in The Tan Sheet

Executive Summary

Contact lens accessory downclassification: Effective July 7, FDA reclassifies rigid gas permeable contact lens solutions, hydrophilic contact lens solutions and contact lens disinfecting units from Class III to Class II in a final rule recently published in the Federal Register. The agency states that all reviews of pending premarket approval applications for the devices are suspended and will be examined to determine those that can be converted to 510(k) submissions and those that may be exempt from 510(k) requirements. FDA asks sponsors to review their applications and advise the agency on the type of administrative action that should be taken. FDA recently announced the availability of a 510(k) guidance for the lens care products ("The Tan Sheet" June 2, p. 17)...

You may also be interested in...



Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC

People In Brief

Perrigo promotes in pricing, planning

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC

Topics

UsernamePublicRestriction

Register

OM007836

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