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

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#1 of 2 Old 05-05-2011, 08:06 PM - Thread Starter
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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streamlined, expanded, or repealed.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.


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#2 of 2 Old 05-06-2011, 07:03 AM - Thread Starter
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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.

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