2001D-0281 - Medical Devices: A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Final Guidance for Industry and FDA Staff; Availability
FDA Comment Number : EC1
Submitter : Ms. Lenore Henning Date & Time: 09/23/2004 06:09:24
Organization : Lenore Henning Enterprises, Inc
Health Professional
Category :
Issue Areas/Comments
I am a nurse inventor. I created a product for use in hospitals to prevent dislocation of patient's medical tubing. I found I had to form a company, get product liability insurance and then sign contract trials with the hospital. As I now look towards the manufacturing and distribution (pre market procedures)of this 'medical device' I'm looking for guidance on FDA regulations for my invention.

Thank you for this opportunity

Lenore Henning RN

Lenore Henning Enterprises, Inc.


By luck, I discovered your site on the final day for comments.