Congress intent to Cease implants - popular in enhancements of The Female and or Endowment of Male includes inner ear

Ammonia poisoning a result from Fish may gasp for air at the surface
of the tank water lead of experiment within Tropical (Tropic) of lab
Animal within flight surgeon jurisdiction frequency Airway - fluid in
the "dish" as evaporation "dish" may gasp for air at the surface of
the tank water is cycle of evaporation cause - electrochemistry
silicone [silicone rubber glue] Dow Corning Clear Silicone Rubber - 60
FR 17208 - Gastroenterology-Urology Devices; Effective Date of
Requirement for Premarket Approvalof Testicular Prosthesis Food and
Drug Administration, HHS.ACTION: Final rule. Drug Administration (FDA)
is issuing a final rule
to require thefiling of a premarket approval application (PMA) or a
notice of completion of a product development protocol (PDP) for the
testicular prosthesis, a generic type of a surgically implanted
medical
device intended to simulate the presence of a testicle within the male
scrotum. Commercial distribution of this device must cease, unless a
manufacturer or importer has filed with FDA a PMA or a notice of
completion of a PDP for its version of the testicular prosthesis
change in the classification of the device based on new information
relevant to its classification. Any
petition requesting a change in the classification of the testicular
prosthesis was required to be represent comments from individuals,
manufacturers, and
professional societies. The comments primarily addressed issues
relating to the significant risks associated with the use of testicular
prostheses, and the preclinical and clinical data needed to support a
future PMA application. The comment requested that FDA describe
the differences between silicone gel-filled and solidsilicone
elastomer testicular implants, and between silicone gel-filled mammary
prostheses and solid silicone elastomer testicular prostheses.
FDA disagrees with this comment. The testicular prosthesis was
classified into class therefore, many of the risks
associated with the use of the silicone gel-filled breast prosthesis
may also be associated with the solid silicone and silicone gel-filled
testicular prosthesis. More than 10 years have passed
since these devices were classified into class by final regulation.
Furthermore, the risks to health detailed in the proposed rule remain
consistent with those identified at the time of classification.
responsible to suggest that Congress intended
manufacturers to remain manufacturers anticipate a final regulation and be
prepared to submit appropriate applications or discontinue distribution
of their devices.
Comment stated that FDA's treatment of ear and testicular
prostheses (both cosmetic implants) is disparate, because no[ne]
psychological [drama] data was required for ear prostheses, and suggested that
the proposed requirement for psychological [Act] data is [un]precedented in the
regulation process.
FDA disagrees with this comment. Ear and testicular prostheses are
different devices, and have been classified by different panels. Ear
prostheses, which are class II devices, were classified by the General
and Plastic Surgery Panel. The review of such plastic surgery
prostheses, such as chinprostheses, takes into consideration the
quality of life of the patient. FDA notes that psychological data is
only part ofthe effectiveness evaluation outlined in the proposed
rule. Moreover, the request for such datais not unprecedented. Thus,
it is clear that Congress of the act, FDA
included in the preamble to the proposal the agency's proposed findings
regarding: (1) The degree of risk of illness or injury designed to be
Commercial distribution of this device must cease.

--
President of The United States
Guy Ralph Perea Sr President of The United States
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