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

New Questionnaire Tools Could Help FDA Review Artificial Pancreases

Executive Summary

The sixth Medical Device Development Tool qualified by the US FDA allows makers of artificial pancreases to provide data on psychosocial effects and quality-of-life changes of patients using their product. Ultimately, it may be the key to whether the agency allows the product on the market or not.

You may also be interested in...



A Deep Dive With US FDA’s Suzanne Schwartz: COVID-19, Cybersecurity, Device Shortages, And More

As head of the device center’s emergency response program, Schwartz oversees a broad range of issues, from medical device shortages to cybersecurity vulnerabilities. We talk to her in this Medtech Insight profile.

US FDA Adds 14 New Regulatory Tools To Help It Review Medical Devices

The tools include new laboratory methods, and computational models and simulations give the agency more capabilities to test and validate data in premarket submissions.

Shuren: More Than A Dozen MDDTs Under Review, But No More This Year

The head of US FDA's device center says there are a substantial number of medical device development tools under review by the agency that could help speed up data collection for product approvals and clearances, but they are not likely to be OK'd by the agency until next year.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT142348

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