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

'Quik' Review Program Builds On US FDA eSubmission Efforts

Executive Summary

The agency says 510(k)s submitted via an electronic template for any of about 40 product types might get a speedier review under a new pilot program.

You may also be interested in...



FDA Gives Insight On Changing Approval Landscape

Device center officials at the US agency focused on new approval pathways at RAPS Convergence 2020.

An FDA Age-Based Predicate Policy Would Be Arbitrary, Reg Experts Complain

The device industry is still sorting out the implications of US FDA's recent proposals to make what the agency describes as a major update to the 510(k) process. But regulatory experts say the agency's focus on finding an age-based cut-off for 510(k) predicate devices is misguided, and some argue that Congress should need to sign off on any of the floated policies.

Proposed 510(k) Changes Elicit Some Industry Skepticism

Two 510(k) pilots from US FDA indicate the agency's desire for faster, easier clearances. But some observers aren’t sure if they’ll lead to real improvements.

Related Content

Topics

UsernamePublicRestriction

Register

LL1131980

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