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

Regulation requirements change for UroMed device

This article was originally published in Clinica

Executive Summary

UroMed's Reliance urinary control insert requires a PMA, the US FDA has decided, not a 510(k) as originally thought. After 17 months of interaction, the FDA has converted the application to a PMA track. This unusual step was taken because UroMed says it had been incorrectly advised by the FDA to submit a 510(k). The FDA has said it will carry out the review as expeditiously as possible.

Topics

UsernamePublicRestriction

Register

MT088291

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