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

FDA Finalizes De Novo Process, Updates Related Guidance Docs

Executive Summary

The pathway is used to clear class I and II products that don’t have a predicate device, including many innovative technologies. The original draft rule came out in 2018.

You may also be interested in...



Global Medtech Guidance Tracker: September 2021

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

Minding The Middle: FDA Fleshes Out De Novo Regs As The Program Expands

A new proposed rule on the de novo classification process does not advance any major policy reforms, but its release underscores the growing popularity of the regulatory pathway that provides flexibility for US FDA and industry in the space between 510(k)s and PMAs.

App Developers Turning To HIPAA Compliance In Face Of Growing State Data Privacy Constraints

Manufacturers faced with an increasingly complex landscape of state patient-privacy laws may opt to comply with federal Health Insurance Portability and Accountability Act regulations instead, attorney Brad Rostolsky tells Medtech Insight.

Topics

Related Companies

UsernamePublicRestriction

Register

MT144536

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