Draft Guidance document #1220From: Hill, Linda (Regulatory) [EESUS] [LHill3@EESUS.JNJ.com]
Sent: Thursday, October 23, 2003 4:03 PM
To: 'fdadockets@oc.fda.gov'
Subject: Draft Guidance document #1220

To: FDA Dockets/CDRH 

Subject: Comment to Document #1220 
         Draft Guidance for Industry and FDA Staff 
         Premarket Assessment of Pediatric Medical Devices 

Ethicon Endo-Surgery, Inc. a Johnson & Johnson company would like to make the following comments regarding the above referenced guidance document:

1)  Section III A. Definition of Pediatric Population Subgroups defines Adolescence as ages 12 to 21 years of age.  In most states, age 18 is considered an adult and no longer need parental consent.  Most IRBs consider age 18 and above adult as well.  Therefore, how will FDA treat current on-going clinical studies already initiated that do not account for the new upper limit of 21?

2)  How will FDA handle the thousands of devices that are currently on the market labeled for pediatrics with the upper limit of 18 years of age? 

Thank you for your consideration, 

Linda Hill 
Group Manager, Regulatory Affairs 
Ethicon Endo-Surgery, Inc. 
lhill3@eesus.jnj.com