Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

CDRH Sets Date To Examine Patient-Focused Device Labeling Policies

This article was originally published in The Gray Sheet

Executive Summary

The device center will convene a meeting at FDA headquarters in September to discuss all facets of device patient labeling.

You may also be interested in...



Home-Use E-Labeling Pilot Round 2: CDRH Seeks Volunteers

FDA’s device center issued a request to participate for a pilot asking companies to electronically submit labeling for home-use devices to help develop a label database. This is the agency’s second go at such a pilot but the submissions process appears to be simplified this time around.

Standardized Device Labeling? CDRH Studies Practitioner Perceptions

The format of device labeling is controlled by the individual manufacturer, but CDRH is exploring whether health care practitioners can more easily find information from a more standardized device label template that includes a short-summary section. Industry advocates are skeptical that broad-scale standardization is feasible due to the diversity of devices and device users, but companies are assisting in the center’s plans to perform a cognitive study of clinicians this summer.

FDA Twitter Guidance Lacks Flexibility, And May Be Unconstitutional, Critics Say

Stakeholders say the agency’s communication requirements for space-limited online platforms are too restricting and violate the First Amendment. Many of them are calling on the agency to withdraw the guidance and try again. The device industry has a comparatively toned down response so far, but wants more flexibility.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT034076

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