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

Hearing aid user instructional brochures

This article was originally published in The Gray Sheet

Executive Summary

FDA requests comments by Oct. 25 on whether requiring hearing aid manufacturers to produce and distribute user brochures would be overly burdensome. The notice increases the agency's earlier estimate of the number of hours required to produce each brochure from 40 to 102 staff hours. However, the agency maintains its view that each hearing aid model requires only one brochure, despite comments to the contrary submitted by the Hearing Industries Association last August. HIA estimated the total hours per brochure at 136, charging FDA with "grossly" underestimating the regulatory burden of the requirement
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT012226

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