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

MedWatch Form To Include SUD Info; FDA Surveys Hospital Reprocessing

This article was originally published in The Gray Sheet

Executive Summary

FDA will have to modify MedWatch forms to make reporting adverse events for reprocessed single-use devices easier, under a new reuse provision in the "Medical Device User Fee & Modernization Act.

You may also be interested in...



FDA Readying Validation Guidance In Anticipation Of MDUFMA SUD Deadline

The Medical Device User Fee & Modernization Act's effects on the bundling of multiple reprocessed single-use devices into one premarket submission will be among topics addressed in an upcoming guidance on validation data, according to FDA device center reps

FDA Readying Validation Guidance In Anticipation Of MDUFMA SUD Deadline

The Medical Device User Fee & Modernization Act's effects on the bundling of multiple reprocessed single-use devices into one premarket submission will be among topics addressed in an upcoming guidance on validation data, according to FDA device center reps

CDRH Eyes Hospital Reuse After Completing Low-Risk Device Inspection Pilot

The Center for Devices & Radiological Health is considering a "special emphasis" project focusing on hospital reuse during fiscal year 2003

Related Content

UsernamePublicRestriction

Register

OM006664

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