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


New FDA Requirements Should Not Apply To All Infusion Pumps, Firms Say

This article was originally published in The Gray Sheet

Executive Summary

FDA should tailor new pre-market requirements for infusion pumps to the complexity and risks of different pump types, manufacturers say

You may also be interested in...

Final Guidance: Assurance Cases, But Not Always Clinicals, For Infusion Pumps

In response to a growing number of adverse events, FDA has asked infusion pump manufacturers to submit safety assurance cases to help understand the safety profile of their device when submitting a 510(K). But a final guidance appears to soften expectations that clinical studies always be performed to support clearance.

Is Draft Guidance More Than Meets The Eye? Senators Seek Answers From FDA

Republicans on the Senate HELP Committee say they are concerned that FDA is using draft guidance documents to set substantive policy, which they argue puts companies in a difficult position.

Regulatory News In Brief

FDA issues proposed order requiring PMAs for automated external defibrillators. Allergan's Juvéderm Voluma XC dermal filler gets panel date. More regulatory news.

Related Content





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