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

US FDA's Software Pre-Cert Program: Is The Authority On The Books?

Executive Summary

The agency is building its pre-certification program as a novel paradigm for health software products to reach the market with less scrutiny when companies successfully undergo "excellence" appraisals. It has attracted the interest and support of many stakeholders, but at least one medtech group argues the agency should have to get congressional approval to launch the program.

You may also be interested in...



Shuren: FDA Making ‘Pre-Cert Simulator’ To ‘Test Drive’ Regulatory Frameworks For Digital Health Tech

US FDA device center director Jeff Shuren said on 6 October that the agency is developing a “precertification simulator” that will allow it to assess different regulatory frameworks in the digital health space.

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.

Pre-Cert Program Will Start Off Slow With De Novo Framing, But Big Questions Remain

Several experts suggest FDA is toeing the line in keeping the first stage of its pre-certification program for software-as-a-medical-device products legally permissible, but it may be limited in scope for the time being. Meanwhile, one attorney says the agency is sending mixed messages about whether the current program will sit comfortably within FDA's current authorities.

Related Content

Topics

UsernamePublicRestriction

Register

MT123064

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