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

QUOTED. Dec. 18, 2018. Scott Gottlieb.

Executive Summary

A new report from US FDA concludes, for the most part, that the benefits of a slew of non-device software functions not regulated by the agency outweigh their risks. The report sends a signal to industry that regulators are happy with the current situation and have no incentive to expand their oversight of such products. See what FDA Commissioner Scott Gottlieb said about it here.

“While we believe that the benefits of these products generally outweigh the risks to patients, we still encourage consumers and health-care providers who use these technologies to stay informed about the benefits and risks of these and any digital health products they are considering using or recommending for their patients. Moving forward, the FDA will continue to update this report to ensure the agency is striking the right balance in our approach to digital health.” –Scott Gottlieb, commissioner, US FDA

Click here for a free trial of Medtech Insight

 
Advertisement

Related Content

Topics

Advertisement
UsernamePublicRestriction

Register

MT124389

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