Medtech Insight is part of the Business Intelligence Division 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

US FDA Emphasizes Timesavers In New eCopy Guidance

This article was originally published in Clinica

Executive Summary

The US FDA's device center wants PDFs submitted through the system to be formatted properly to prevent unnecessary delays when reviewers work with them. With this aim in mind, on Dec. 3, the Center for Devices and Radiological Health released an updated guidance (PDF) for industry on its electronic copy (eCopy) program for medical device submissions based on recommendations from Booz Allen Hamilton as part of the contractor's ongoing independent review of FDA's procedures.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT103052

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

All set! This Question has been sent to 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