For the urologists here who don't read the Federal Register
every week:
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[Federal Register: December 16, 1997 (Volume 62, Number 241)]
[Proposed Rules]
[Page 65770-65775]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16de97-15]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. 97N-0481]
Gastroenterology-Urology Devices: Reclassification of the Penile
Rigidity Implant
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify the penile rigidity implant, a medical device intended to
provide penile rigidity in men diagnosed as having erectile
dysfunction, from class III to class II. The special controls
identified in this proposed rule are the physician and patient
labeling, biocompatibility testing, mechanical reliability performance
testing, clinical testing, and sterilization requirements described in
FDA's guidance document entitled ''Guidance for the Content of
Premarket Notifications for Penile Rigidity Implants.'' This
reclassification is being proposed on the agency's own initiative based
on new information. This action is being taken under the Federal Food,
Drug, and Cosmetic Act (the act), as amended by the Medical Device
Amendments of 1976 (the 1976 amendments) and the Safe Medical Devices
Act of 1990 (the SMDA).
DATES: Written comments by March 16, 1998. FDA proposes that any final
regulation based on this proposal become effective 30 days after its
date of publication in the Federal Register.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: John H. Baxley, Center for Devices and
Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2194. |
