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

Digital Health, Diagnostic Focus Included In FDA Commissioner's 2018 Strategy

Executive Summary

Starting out 2018, Scott Gottlieb issued a new directive to US FDA staff outlining his priorities and vision. Among the directives is to promote digital health and diagnostics by creating efficient pathways for new products in the areas and focusing on technology to help consumers better track their health.

You may also be interested in...



Top FDA Officials Warn About Non-Vetted Pharmacogenetic Tests After Latest 23andMe Approval

A day after 23andMe gained US FDA go-ahead for a DTC genetic test service to inform patients about their ability to metabolize medications, the agency issued a safety communication, paired with a joint statement from device- and drug-center heads, warning consumers against trusting genetic tests that have not been vetted by FDA.

US FDA Greenlights First Direct-To-Consumer Cancer-Risk Test

23andMe gained FDA go-ahead for the first direct-to-consumer genetic test for cancer risk, as the firm continues to map out regulatory frameworks for the DTC gene-screening space with its third de novo authorization in three years.

FDA's US-First Strategy: Device Center Sets Three-Year Goals

A new three-year plan to implement strategic priorities at US FDA's device center aims to make several broad improvements to the medtech ecosystem. Among them is improving staff incentives at the agency, creating more partnerships with industry and other stakeholders, and improving the center's processes to make it easier for novel medical devices to enter the US market.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT122042

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