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 
  


  

  



  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 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



President

Lenore Henning Enterprises, Inc.



Lenore_Henning@cdh.org



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