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

'FDA adjusting regulatory structures with evolving science' with US approval of first DTC genetic test

This article was originally published in SRA

Executive Summary

In addition to approving the first ever direct-to-consumer genetic test in the US, the Food and Drug Administration has announced that it intends to ease up its regulatory oversight of such tests that are offered to the public for screening of possible gene disorders by classifying them as Class II (medium-risk) devices and exempting them from for premarket review1.

Advertisement
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT040461

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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