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

LATEX CONDOM EXPIRATION DATING BASED ON ACCELERATED AGING DATA WOULD BE ALLOWED UNDER PROPOSED RULE; NO 510(k) NEEDED FOR LABELING ADDITION

This article was originally published in The Gray Sheet

Executive Summary

FDA would permit latex condom expiration dating of up to five years based on short-term accelerated aging studies under a proposed rule published in the May 24 Federal Register. Upon successful completion of tests in which packaged condoms would be stored at 70C for seven days and at 40-50C for 90 days, manufacturers could label products for a shelf life of up to five years, FDA says.

You may also be interested in...



Wockhardt Preps To Deliver 100 M Doses Of AZ Vaccine

As the MHRA prepares to grant approval to the Oxford/AstraZeneca vaccine, Wockhardt is set to supply 100 million doses for the UK government’s own use and its WHO commitments. The company is also in talks with global vaccine developers to manufacture their COVID-19 vaccines for emerging economies

ECHA Deliberates On Final Microplastic Proposal As Beauty Industry’s Fate Hangs In Balance

A combined final opinion on the European Chemicals Agency’s proposed microplastic restriction is expected from ECHA committees by year-end, at which point the European Commission will consider whether and when microplastic must be removed from all leave-on cosmetic products marketed in the EU.

QUOTED. 2 December. Laurent Faracci.

Butterfly Network’s CEO Laurent Faracci outlines the company’s growth strategy and plans for their “ultrasound-on-a-chip” technology after its merger with blank check company Longview Acquisition Corp. See what the company’s CEO said about it here.

UsernamePublicRestriction

Register

PS100968

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