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

FDA Says AI Regulations May Require More Congressional Authorities

Executive Summary

The top official on artificial intelligence products at the US FDA says that while the agency has some authorities to implement regulatory oversight, it may need additional powers from Congress considering the direction the FDA may possibly take in regulating AI and machine learning products.

You may also be interested in...



Q&A: FDA Device Center Director Lays Out 2020 Priorities

Jeff Shuren discussed CDRH’s recent successes and his plans for the remainder of 2020, including priorities for upcoming MDUFA negotiations, in an exclusive interview with Medtech Insight. Check out our podcast or read the transcript.

Podcast: US FDA’s Artificial Intelligence Guidance May Need Congress And Is At Least A Year Away, Expert Says

Zach Rothstein, the top artificial intelligence and machine learning lobbyist at device industry advocacy group AdvaMed, wrote to the US FDA with recommendations on how to regulate AI/ML devices. He sat down with Medtech Insight to break down the topic's most important issues.

If You Build It, They Will Come: FDAer Says Pre-Cert Program Getting Global Attention, AI Paper Just the Start

International regulators are interested in seeing how they too can apply the US FDA’s precertification program, which is currently in the pilot stage. In an exclusive interview with Medtech Insight, the agency’s top digital health officer, Bakul Patel, talks about global curiosity about the program that could allow companies to get certain medical software on the market based on trust. Patel also expects an upcoming artificial intelligence draft guidance from the FDA will form from a recent discussion paper – but he says industry needs to do more.

Related Content

Topics

UsernamePublicRestriction

Register

MT126445

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