[Federal Register Volume 63, Number 175 (Thursday, September 10, 1998)]
[Notices]
[Pages 48516-48517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24243]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0670]
Devices Used for In Vitro Fertilization and Related Assisted
Reproduction Procedures: Submission Guidance for a 510(k); Draft;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Devices Used for In Vitro
Fertilization and Related Assisted Reproduction Procedures: Submission
Guidance for a 510(k).'' This draft guidance is neither final nor is it
in effect at this time. This draft guidance outlines the information to
be submitted in a premarket notification submission (510(k)) for
medical devices that are intended to be used for in vitro fertilization
(IVF), gamete intrafallopian transfer (GIFT), zygote intrafallopian
transfer (ZIFT), intracytoplasmic sperm injection (ICSI), embryo
transfer (ET), and related assisted reproduction technology (ART)
procedures.
DATES: Written comments concerning this draft guidance must be
submitted by December 9, 1998.
ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Devices Used for In Vitro Fertilization and Related
Assisted Reproduction Procedures: Submission Guidance for a 510(k)'' to
the Division of Small Manufacturers Assistance (HFZ-220), Center for
Devices and Radiological Health, Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive
labels to assist that office in processing your request, or fax your
request to 301-443-8818. Written comments concerning this draft
guidance must be submitted to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Comments should be identified with the docket number found in
the brackets in the heading of this document. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
FURTHER INFORMATION CONTACT: Elisa D. Harvey, Center for Devices and
Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1180.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance outlines the information to be submitted in a
510(k) for medical devices that are intended for use in IVF, GIFT,
ZIFT, ICSI, ET, and ART procedures. On January 29, 1988, and October
21, 1995, FDA consulted with the Obstetrics and Gynecology Devices
Panel (the Panel) regarding its regulatory strategy and the
classification of these devices. Both times the Panel agreed that
premarket approval is not necessary to provide reasonable assurance of
the safety and effectiveness of the devices used for IVF and ART.
Therefore, in the Federal Register of September 4, 1997 (62 FR 46686),
FDA published a proposed rule to reclassify instrumentation intended
for use in IVF and related ART procedures from class III to class II.
FDA also proposed to reclassify assisted reproduction microscopes and
microscope accessories from class III to class I and to exempt them
from the requirement of premarket notification (510(k)).
II. Significance of Guidance
This draft guidance represents the agency's current thinking on the
information needed in a 510(k) intended to be used for ART procedures.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the applicable statute, regulations, or
both.
The agency has developed good guidance practices (GGP's) to set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (62 FR 8961, February 27,
1997). This draft guidance is a level 1 document consistent with the
GGP's.
III. Electronic Access
In order to receive ``Devices Used for In Vitro Fertilization and
Related Assisted Reproduction Procedures: Submission Guidance for a
510(k)'' via your fax machine, call the CDRH Facts-On-Demand (FOD)
system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. At
the first voice prompt press 1 to access DSMA Facts, at second voice
prompt press 2, and then enter the document number 620 followed by the
pound sign (). Then follow the remaining voice
prompts to complete your request.
Persons interested in obtaining a copy of the draft guidance may
also do so using the World Wide Web (WWW). The Center for Devices and
Radiological Health (CDRH) maintains an entry on the WWW for easy
access to information including text, graphics, and files that may be
downloaded to a personal computer with access to the WWW. Updated on a
regular basis, the CDRH home page includes ``Devices Used for In Vitro
Fertilization and Related Assisted Reproduction Procedures: Submission
Guidance for a 510(k),'' device safety alerts, Federal Register
reprints, information on premarket submissions (including lists of
approved applications and manufacturers' addresses), small
manufacturers' assistance, information on video conferencing and
electronic
[[Page 48517]]
submissions, mammography matters, and other device-oriented
information. The CDRH home page may be accessed at http://www.fda.gov/
cdrh. The draft guidance entitled ``Devices Used for In Vitro
Fertilization and Related Assisted Reproduction Procedures: Submission
Guidance for a 510(k)'' will be available at http://www.fda.gov/cdrh/
ode/ed_rp.html.
IV. Comments
Interested persons may, on or before December 9, 1998, submit to
the Dockets Management Branch (address above) written comments
regarding this draft guidance. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. The draft guidance and received comments may be seen
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: August 25, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-24243 Filed 9-9-98; 8:45 am]
BILLING CODE 4160-01-F
