FDA seeking public comments in review of existing regulations (deadline 27 June 2011). - Mothering Forums

Forum Jump: 
 
Thread Tools
#1 of 2 Old 05-05-2011, 08:06 PM - Thread Starter
 
Minuteman's Avatar
 
Join Date: Feb 2011
Location: Australia
Posts: 204
Mentioned: 0 Post(s)
Tagged: 0 Thread(s)
Quoted: 0 Post(s)

This could be an opportunity to bring to the FDA our concerns regarding the use of neonatal foreskins in the development of cosmetic and medical products, particularly in the light of increased risks to male infants from community acquired MRSA, new research on the harm to sexual health caused by circumcision and the availability of alternatives (as used in Europe and around the rest of the world).

I'll start work on a response document over the weekend.

Link: http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0259-0001

SUMMARY: In accordance with Executive Order 13563, ``Improving
Regulation and Regulatory Review,'' the Food and Drug Administration
(FDA) is conducting a review of its existing regulations to determine,
in part, whether they can be made more effective in light of current
public health needs and to take advantage of and support advances in
innovation. The goal of this review of existing regulations, as with
our other reviews, is to help ensure that FDA's regulatory program is
more effective and less burdensome in achieving its regulatory
objectives. FDA is requesting comment and supporting data on which, if
any, of its existing rules are outmoded, ineffective, insufficient, or
excessively burdensome and thus may be good candidates to be modified,
streamlined, expanded, or repealed. As part of this review, FDA also
invites comment to help us review our framework for periodically
analyzing existing rules.



 

Minuteman is offline  
#2 of 2 Old 05-06-2011, 07:03 AM - Thread Starter
 
Minuteman's Avatar
 
Join Date: Feb 2011
Location: Australia
Posts: 204
Mentioned: 0 Post(s)
Tagged: 0 Thread(s)
Quoted: 0 Post(s)

I was just having a look at the FDA site and realised that safety concerns over circumcision devices are another area where stronger regulations could be argued for:

Link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm173115.htm

'Circumcision Clamps

Potential for injury from two commonly used circumcision clamps, the Gomcor/gomco-type and Mogenr/mogen-type clamps. Both are widely used during circumcision to remove the foreskin while protecting the glans penis. FDA received 105 reports of injuries involving circumcision clamps between July 1996 and January 2000. These have included laceration, hemorrhage, penile amputation, and urethral damage.

[September 1, 2000 - Device Safety Notification - FDA]'

Since this safety alert, the Mogen company have gone out of business after losing a $U.S. 11m lawsuit.

Minuteman is offline  
Reply

Quick Reply
Message:
Drag and Drop File Upload
Drag files here to attach!
Upload Progress: 0
Options

Register Now

In order to be able to post messages on the Mothering Forums forums, you must first register.
Please enter your desired user name, your email address and other required details in the form below.
User Name:
If you do not want to register, fill this field only and the name will be used as user name for your post.
Password
Please enter a password for your user account. Note that passwords are case-sensitive.
Password:
Confirm Password:
Email Address
Please enter a valid email address for yourself.
Email Address:

Log-in

Human Verification

In order to verify that you are a human and not a spam bot, please enter the answer into the following box below based on the instructions contained in the graphic.



User Tag List

Thread Tools
Show Printable Version Show Printable Version
Email this Page Email this Page


Forum Jump: 

Posting Rules  
You may post new threads
You may post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off
Trackbacks are On
Pingbacks are On
Refbacks are Off