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

TurboTax For 510(k)s? FDA Seeks Volunteers For eSubmissions Pilot

This article was originally published in The Gray Sheet

Executive Summary

The agency has launched a pilot that will allow makers of cardiac diagnostic and peripheral interventional devices to submit 510(k)s in electronic-only format. FDA says it expects the program to improve both speed and quality of submissions.

Advertisement

Related Content

'Quik' Review Program Builds On US FDA eSubmission Efforts
FDA, Industry Agree On Working Groups To Support User-Fee Negotiations
FDA Tries To Get 'Smart' In Standardizing 510(k) Reviews
Updated eCopy Guidance Clarifies FDA’s Electronic Submission Program
FDA Plans To Audit Its New 510(k) Refuse-To-Accept Program
CDRH Prepares For Electronic Recall Submissions; Pre-Market Still A Challenge
Mandatory Electronic Review, Voluntary E-Submissions On OIVD Horizon

Topics

Advertisement
UsernamePublicRestriction

Register

MT032948

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