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

Final FDA Bill: Device Provisions

This article was originally published in The Gray Sheet

Executive Summary

Congress has settled on final language for the FDA Safety and Innovation Act. After Senate approval, the bill will go to the White House for President Obama’s signature.

You may also be interested in...



FDA To Consider Patient Input For Benefit-Risk Decisions For IDEs

The agency will take into account patient preferences when making benefit-risk determinations for investigational device exemptions, according to a June 18 draft guidance.

FDA Draft Guidance Provides Definitions, Recommendations For Custom Devices

FDA’s draft guidance defines terms used in its custom device exemption, which limits the production of such devices to “five units per year of a particular device type,” and provides recommendations for information to be included in annual reports.

CDRH Officials Talk New Guidance, Post-Market Surveillance And 510(k)s At AdvaMed

CDRH Director Jeffrey Shuren told participants at the AdvaMed annual meeting to expect early feasibility studies final guidance very soon and a guidance on 3D printing within two years. The center also announced updates on its national post-market surveillance plan and 510(k) refuse-to-accept policy programs, among other matters.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT031330

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