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

US FDA Asks For Public Input On Software It Can't Regulate

Executive Summary

FDA is writing a report on key safety impacts from health software products that fall outside of its regulatory purview under the 21st Century Cures Act. To help the effort, the agency is asking industry, patient groups and other stakeholders to chime in by June 28.

You may also be interested in...



US FDA Medical Software Report Rests Concerns Of Increased Regulation

Based on a provision in the 21st Century Cures Act, US FDA has released a report that shows that certain types of medical software not regulated by the agency is overwhelmingly beneficial to the public with few risks. The report seems to allay industry fears that FDA may use it to ask for more oversight authority of such products.

US FDA Shelves Proposal To Mandate Home-Use Device E-Labeling

A controversial 2016 proposed rule that would have required manufacturers of many class II and class III home-use devices to electronically submit device labeling information to US FDA will not be finalized, the agency affirmed in the Oct. 17 HHS Unified Agenda document. The agency also signaled plans to imminently finalize a broad device classification rule, and other updates.

FDA's Bakul Patel Discusses Pre-Cert Program Working Model

In a Medtech Insight exclusive podcast interview, US FDA's Bakul Patel talks about what the agency wants to learn from a newly released "working model" intended to set the initial foundations for the digital health pre-certification program. The first version of the program will start before year's end and he's hoping for industry feedback to prepare for it.

Related Content

Topics

UsernamePublicRestriction

Register

LL1131980

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