[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availability of the draft guidance entitled ``Devices Used for In Vitro 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 This draft guidance is neither final nor is it 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 This draft guidance outlines the information to 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DATES: Written comments concerning this draft guidance must be 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ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Devices Used for In Vitro Fertilization and Related 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 Written comments concerning this draft 
guidance must be submitted to the Dockets Management Branch (HFA-305), 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