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

SIMPLIFIED (SECTION) 10(k)s FOR SOME RADIOLOGY DEVICES ARE ACCEPTABLE

This article was originally published in The Gray Sheet

Executive Summary

SIMPLIFIED (SECTION) 10(k)s FOR SOME RADIOLOGY DEVICES ARE ACCEPTABLE as of Jan. 1, FDA says in a Dec. 21 letter to the National Electrical Manufacturers Association, In 510(k)s for "certain" x-ray and computed tomography systems, sponsors "need only to certify that the device meets the applicable requirement" of FDA's Performance Standard for Ionizing Radiation Emitting Products, FDA tells NEMA. Previously, 510(k)s had to include data demonstrating compliance with the standard. Under the new policy, "all data should be available for inspection at the firm," the agency stipulates.

You may also be interested in...



US FDA Pharmaceutical Quality Office Lauds Continuous Manufacturing Approvals

The FDA’s OPQ touts approval of sixth and seventh continuously manufactured drugs and quicker delivery of inspection results in latest annual report.

Warning Letter Roundup & Recap – 19 February 2020

No device-related warning letters were released by the US FDA the week of 19 February.

Harmonization Needed For Complex And Value-Added Drugs

Complex generics and value added medicines share common challenges on harmonization of regulation, lack of incentives and clarity of guidelines, heard delegates to Medicines for Europe’s Regulatory & Scientific Affairs conference.

UsernamePublicRestriction

Register

MT001677

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