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

Your Device Doesn’t Qualify For An FDA Export Certificate? You Might Get A Non-Export Certificate

Executive Summary

The agency has issued a notice explaining how products that do not qualify for an export certificate may still get a Certificate for Device Not Exported when marketing outside the US.

You may also be interested in...



FDA Issues Final Export Certificate Guidance, Explains What To Do If Your Firm Is Turned Down For One

An 8-page final guidance from the US agency lays bare reasons why it would deny an export certificate to a company. It also explains how a firm can appeal if it is turned down for a certificate. The guidance was developed because the FDA Reauthorization Act of 2017 – FDARA – required the agency to provide a rationale when it turns down a request for a Certificate to Foreign Government (CFG), including listing any specific grounds for a finding of noncompliance.

MDIC Proposes Real-World Evidence Framework For Sponsors To Hasten Product Applications

The document from the Medical Device Innovation Consortium aggregates external data sources, various statistical methods and lays out other considerations for sponsors to help speed up and bolster a premarket product application to the US FDA.

Ericsson Is Readying For A 5G Health Care Revolution

A top executive at the Swedish company spoke with Medtech Insight about how the mobility and data reliability of 5G cellular technology will change how medtech manufacturers design their products.

Topics

UsernamePublicRestriction

Register

ID007083

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