Scrip 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

US FDA risk-based screening system testing device imports

This article was originally published in RAJ Devices

Executive Summary

The US Food and Drug Administration is testing a new risk-based IT system that will screen imports of medical devices to ensure they comply with US regulations1,2.

You may also be interested in...



Stakeholders Deliberate on Developing US Social Media Guidance

Jeanette Marchant reports on discussions at the US Food and Drug Administration public hearing on how drug and medical device companies should use the internet and social media to promote regulated products.

Stakeholders Deliberate on Developing US Social Media Guidance

Jeanette Marchant reports on discussions at the US Food and Drug Administration public hearing on how drug and medical device companies should use the internet and social media to promote regulated products.

Asian group identifies criteria for device nomenclature system

The Asian Harmonization Working Party agreed six criteria for a medical device nomenclature system at its 14th meeting in Hong Kong on 4-7 November 20091. The requirements ? which will help in the selection of a nomenclature system service provider ? cover charges for using the system; its governance; ownership of the database; response times to requests; the system’s future development; and further use.

Latest Headlines
See All
UsernamePublicRestriction

Register

SC095768

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. 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