[Federal Register Volume 64, Number 149 (Wednesday, August 4, 1999)]
[Notices]
[Pages 42391-42392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19976]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-2171]
Medical Devices; Draft Guidance for the Accountability Analysis
for Clinical Studies for Ophthalmic Devices; 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availability of the draft guidance entitled, ``Accountability Analysis
for Clinical Studies for Ophthalmic Devices.'' This guidance is
intended to provide general information about the analysis of
accountability of subjects in clinical studies in ophthalmic device
investigational device exemption applications and marketing
applications and notifications. By providing a reference point for the
reporting of accountability information, FDA hopes that terminology and
methods of presentation can be standardized so that the agency and
sponsors can more effectively analyze these data. This guidance is not
final nor is it in effect at this time.
DATES: Written comments concerning this guidance must be submitted by
November 2, 1999.
ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the guidance. Submit written requests for single
copies on a 3.5'' diskette of the guidance document entitled
``Accountability Analysis for Clinical Studies for Ophthalmic Devices''
to the Division of Small Manufacturers Assistance (HFZ-220), Center for
Devices and Radiological, Food and Drug Administration, 1350 Piccard
Dr., Rockville, MD 20850. Send one self-addressed adhesive label to
assist the office in processing your request, or fax your request to
301-443-8818. Submit written comments on the document to the Dockets
Management Branch, (HFA-305), Food and Drug Administration, rm 1061,
5630 Fishers Lane, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Donna R. Lochner, Center for Devices
and Radiological Health (HFZ-463), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2053.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance entitled
``Accountability Analysis for Clinical Studies for Ophthalmic
Devices.'' This guidance document provides background information that
FDA and the sponsor can use in preparing accountability analyses for
subjects enrolled in clinical studies of ophthalmic devices. It
provides definitions of common terminology used in describing
accountability, considerations for presentation of a ``lost to follow-
up''analysis, and sample formats for presentation of accountability.
FDA has noted that there is often a misunderstanding in the meaning of
certain terms used to describe accountability, which can confuse the
presentation of the accountability data. Further, sponsors have
frequently requested that FDA provide them with sample formats for
presentation of accountability data. This guidance document attempts to
provide some clarity in these areas.
II. Significance of Guidance
This guidance document represents the agency's current thinking on
the accountability analysis for ophthalmic devices. 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 adopted good guidance practices (GGP's), which set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (62 FR 8961, February 27,
1997). This guidance document is issued as a Level 1 guidance
consistent with GGP's.
III. Electronic Access
In order to receive the draft guidance entitled ``Accountability
Analysis for Clinical Studies for Ophthalmic Devices'' 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 (1350) followed by the pound sign (#). Then
follow the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the guidance may also do
so using the World Wide Web (WWW). CDRH maintains an entry on the World
Wide Web for easy access to information including text, graphics, and
files that may be downloaded to a PC with access to the Web. Updated on
a regular basis, the CDRH home page includes the draft guidance
entitled ``Accountability Analysis for Clinical Studies for Ophthalmic
Devices,'' 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 submissions, mammography matters,
and other device-oriented information.
[[Page 42392]]
The CDRH home page may be accessed at ``http://www.fda.gov/cdrh''.
IV. Comments
Interested persons may, on or before November 2, 1999, submit to
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. The guidance document and
received comments may be seen in the Dockets Management Branch between
9 a.m. and 4 p.m., Monday through Friday. Comments should be identified
with the docket number found in brackets in the heading of this
document.
Dated: July 20, 1999
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 99-19976 Filed 8-3-99; 8:45 am]
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