[Federal Register Volume 62, Number 112 (Wednesday, June 11, 1997)]
[Notices]
[Pages 31831-31832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15167]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97M-0186]
Millenium Medical Supply, Inc.; Premarket Approval of Needle-
EaseTM 2501
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing its
approval of the application submitted by Louise N. Howe of the law firm
HALE and DORR, as the U.S. Representative on behalf of Millenium
Medical Supply, Inc., Ontario, Canada, for premarket approval, under
the Federal Food, Drug, and Cosmetic Act (the act), of Needle-
EaseTM 2501. FDA's Center for Devices and Radiological
Health (CDRH) notified the applicant, by letter of March 6, 1997, of
the approval of the application.
DATES: Petitions for administrative review by July 11, 1997.
ADDRESSES: Written requests for copies of the summary of safety and
effectiveness data and petitions for administrative review to the
Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Chiu S. Lin, Center for Devices and
Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-443-8913.
SUPPLEMENTARY INFORMATION: On December 6, 1996, Louise N. Howe of the
law firm HALE and DORR, as the U.S. Representative on behalf of
Millenium Medical Supply, Inc., Ontario, Canada, N3T 5M1, submitted to
CDRH an application for premarket approval of Needle-EaseTM
2501. This device is a sharps needle destruction device that is
intended for home use by diabetics to reduce the incidence of
needlesticks by the incineration of 28-30 gauge needles, 29 and 30
gauge diabetic ``pen tips,'' and 23-26 gauge diabetic lancets.
In accordance with the provisions of section 515(c)(2) of the act
(21 U.S.C. 360e(c)(2)) as amended by the Safe Medical Devices Act of
1990, this premarket approval application (PMA) was not referred to the
General Hospital and Personal Use Devices Panel of the Medical Devices
Advisory Committee, an FDA advisory committee, for review and
recommendation because the information in the PMA substantially
duplicates information previously reviewed by this panel. On March 6,
1997, CDRH approved the application by a letter to the applicant from
the Director of the Office of Device Evaluation, CDRH.
A summary of the safety and effectiveness data on which CDRH based
its approval is on file in the Dockets Management Branch (address
above) and is available from that office upon written request. Requests
should be identified with the name of the device and the docket number
found in brackets in the heading of this document.
Opportunity For Administrative Review
Section 515(d)(3) of the act authorizes any interested person to
petition, under
[[Page 31832]]
section 515(g) of the act, for administrative review of CDRH's decision
to approve this application. A petitioner may request either a formal
hearing under part 12 (21 CFR part 12) of FDA's administrative
practices and procedures regulations or a review of the application and
CDRH's action by an independent advisory committee of experts. A
petition is to be in the form of a petition for reconsideration under
(21 CFR 10.33(b)). A petitioner shall identify the form of review
requested (hearing or independent advisory committee) and shall submit
with the petition supporting data and information showing that there is
a genuine and substantial issue of material fact for resolution through
administrative review. After reviewing the petition, FDA will decide
whether to grant or deny the petition and will publish a notice of its
decision in the Federal Register. If FDA grants the petition, the
notice will state the issue to be reviewed, the form of the review to
be used, the persons who may participate in the review, the time and
place where the review will occur, and other details.
Petitioners may, at any time on or before July 11, 1997, file with
the Dockets Management Branch (address above) two copies of each
petition and supporting data and information, identified with the name
of the device and the docket number found in brackets in the heading of
this document. Received petitions may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
This notice is issued under the Federal Food, Drug, and Cosmetic
Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10)
and redelegated to the Director, Center for Devices and Radiological
Health (21 CFR 5.53).
Dated: April 22, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 97-15167 Filed 6-10-97; 8:45 am]
BILLING CODE 4160-01-F
