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

Legislation Would Streamline Risk-Classification For Device Accessories

Executive Summary

A bill introduced in the US that industry stakeholders want to be added to the "must-pass" user-fee reauthorization bill would create a tailored approach to classifying or reclassifying device accessories, following up on change made last year that requires accessories to be classified separately from parent devices. Streamlining accessory oversight has been an industry goal, particularly of health-software makers.

You may also be interested in...



MDUFA IV (And More) Is Law: Trump Signs A Health-Care Bill

President Trump's eleventh-hour signature on the FDA Reauthorization Act puts into play about $1bn in device user-fee collections from industry through FY 2022, new US FDA performance goals and a range of device process enhancements and reforms supported by industry.

House Committee Advances User Fees With Full Slate Of Device Amendments

House Energy and Commerce Committee members added a slate of industry-favored device amendments into the FDA Reauthorization Act before sending the bill to the chamber floor, including reforms targeting device accessories, medical imaging and post-market surveillance.

Podcast: Nadim Yared Hits The Ground Running As AdvaMed Chair

In a podcast interview to discuss his initial experience as chairman of AdvaMed, CVRx CEO Nadim Yared talks about the group's laser focus on device-tax repeal, irrespective of broader GOP health-care debates and controversy, its capacity to handle unpredictability and change in Washington, DC, and more.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

OM007466

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