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

FDA officials summarise the agency's advance:

This article was originally published in Clinica

Executive Summary

The investigational device exemptions granted by the FDA within 30 days of submission have more than doubled to 73 in the past three years. The backlog of PMA supplements, which authorise companies to make significant changes to high-risk devices, has been reduced by a factor of 10 in the same period. The backlog of 510(k) submissions, for which the agency must determine whether the technology described has substantial equivalence to existing products, is now one a month at most, compared with 2,000 in 1993.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT084566

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