[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Medical Devices; Draft Guidance for the Accountability Analysis 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availability of the draft guidance entitled, ``Accountability Analysis 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    FDA is announcing the availability of a draft guidance entitled 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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