[Federal Register Volume 59, Number 97 (Friday, May 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12374]
[[Page Unknown]]
[Federal Register: May 20, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0128]
OrthoLogic Corp.; Premarket Approval of OrthoLogicTM 1000
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 by OrthoLogic Corp., Phoenix, AZ, for
premarket approval, under section 515 of the Federal Food, Drug, and
Cosmetic Act (the act), of the OrthoLogicTM 1000. FDA's Center for
Devices and Radiological Health (CDRH) notified the applicant by letter
on March 4, 1994, of the approval of the application.
DATES: Petitions for administrative review by June 20, 1994.
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, rm.
1-23, 12420 Parklawn Dr., Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Marie A. Schroeder, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 1390
Piccard Dr., Rockville, MD 20850, 301-594-1230.
SUPPLEMENTARY INFORMATION: On November 18, 1991, OrthoLogic Corp.,
Phoenix, AZ 85034, submitted to CDRH an application for premarket
approval of the OrthoLogicTM 1000. The device is a noninvasive
osteogenesis therapy system and is indicated for the noninvasive
treatment of an established nonunion acquired secondary to trauma,
excluding vertebrae and all flat bones, where the width of the nonunion
defect is less than one-half the width of the bone to be treated. A
nonunion is considered to be established when a minimum of 9 months has
elapsed since injury and the fracture site shows no visibly progressive
signs of healing in a minimum of 3 months. The OrthoLogicTM 1000
is a portable, battery-powered, microcontrolled, noninvasive bone
growth stimulator which produces very low energy combined static and
dynamic magnetic fields. A Liquid Crystal Display (LCD) is utilized to
display the status of the device. In accordance with the provisions of
section 515(f)(2) of the act (21 U.S.C. 360e(f)(2)) as amended by the
Safe Medical Devices Act of 1990, this PMA was not referred to the
Orthopedic and Rehabilitation Devices Panel, an FDA advisory panel, for
review and recommendation because the information in the PMA
substantially duplicates information previously reviewed by this panel.
On March 4, 1994, CDRH approved the application by a letter to the
applicant from the Acting 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 (21 U.S.C. 360e(d)(3)) authorizes any
interested person to petition, under section 515(g) of the act (21
U.S.C. 360e(g)), 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
Sec. 10.33(b) (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
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 June 20, 1994, 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 Center for Devices and Radiological Health (21
CFR 5.53).
Dated: May 11, 1994.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 94-12374 Filed 5-19-94; 8:45 am]
BILLING CODE 4160-01-F
