Medtech Insight is part of the Business Intelligence Division 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

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

Executive Summary

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 Patel also expects an upcoming artificial intelligence draft guidance from the FDA will form from a recent discussion paper – but he says industry needs to do more.

Advertisement

Related Content

Beyond The Hype: Philips CEO Says The Future Is AI Platforms
Listen: FDA's Bakul Patel Talks Pre-Cert Program, Artificial Intelligence
Rise Of The Machines: FDA Artificial Intelligence Guidance Is Coming
2019 Will Be Testing Period For US FDA's Novel Pre-Cert Paradigm For Digital Health
'Excellence' In Health-Software Design: US FDA Taps Nine Firms To Figure Out What That Means
Software Fast Track? US FDA Asks Developers To Envision 'Precheck' Program

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

MT124925

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