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

Gottlieb Unveils Next Steps In Digital Health Plan

Executive Summary

The US FDA Commissioner outlined six new updates to the agency's digital health plan, including a new guidance, the next steps for pre-certification and a digital health focus for drugs.

You may also be interested in...



Drug/Software Combo Pathway Coming Soon To US FDA, Gottlieb Says

Under a new regulatory platform, drugs could soon be approved with accompanying software applications that could monitor adverse events or patient compliance without a separate pre-market device review.

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.

FDA Readies Digital Health Pre-Cert Program For Lift Off

US FDA laid out its proposed starting model to launch the pre-certification program for digital health products, including a matrix for when pre-certified app and software developers could bring new or modified products to market with either streamlined or no pre-market review.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT122570

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