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

Software Fast Track? US FDA Asks Developers To Envision 'Precheck' Program

Executive Summary

Developers of "software as a medical device" are unique to other device-makers in how fast their products are developed and updated. FDA digital health leader Bakul Patel is asking companies to provide input on the agency's idea for an expedited pathway for software that would be based on established trust.

You may also be interested in...



Profile: FDA’s Bakul Patel On The Inevitable Future Of Digital Health

Medtech Insight profiles the man leading the US FDA’s digital health efforts to learn about his journey and vision for the future.

Reimbursement A Top Goal For New Digital Health Lobbying Center

As digital health becomes more ubiquitous in the medical device space, industry advocacy group AdvaMed has launched a Center for Digital Health to aggregate its resources and coordinate efforts to lobby the government on behalf of digital-health companies.

Testing The Limits: Software De Novo, 510(k) Volunteers Wanted By US FDA

As the US Food and Drug Administration is developing a new pathway for certain medical software called the precertification program, the agency is asking de novo and 510(k) sponsors to volunteer for a test plan to help the agency in its efforts. At least one expert on the subject is skeptical and says the plan adds burdens without real benefits for sponsors.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT104564

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