11372 Federal Register / Vol. 72, No. 48 / Tuesday, March 13, 2007 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2003D–0044] 

Guidance for Industry and Food and 

Drug Administration Staff; Statistical 

Guidance on Reporting Results from 

Studies Evaluating Diagnostic Tests; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Statistical Guidance on Reporting 

Results from Studies Evaluating 

Diagnostic Tests.’’ This guidance 

describes some statistically appropriate 

practices for reporting results from 

different studies evaluating diagnostic 

tests and identifies some common 

inappropriate practices. Special 

attention is given to describing a 

practice called discrepant resolution 

and its associated problems. 

DATES: Submit written or electronic 

comments on this guidance at any time. 

General comments on agency guidance 

documents are welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Statistical Guidance on 

Reporting Results from Studies 

Evaluating Diagnostic Tests’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance 

(HFZ–220), Center for Devices and 

Radiological Health, Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 240–276–3151. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. 

Submit written comments concerning 

this guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Kristen Meier, Center for Devices and 

Radiological Health (HFZ–550), Food 

and Drug Administration, 1350 Piccard 

Dr., Rockville, MD 20850, 240–276–

3060. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On February 11, 1998, the Center for 

Devices and Radiological Health (CDRH) 

convened a joint meeting of the 

Microbiology, Hematology/Pathology, 

Clinical Chemistry/Toxicology and 

Immunology Devices Panels. The 

purpose of this meeting was to obtain 

recommendations on ‘‘appropriate data 

collection, analysis, and resolution of 

discrepant results, using sound 

scientific and statistical analysis to 

support indications for use of the in 

vitro diagnostic devices when the new 

device is compared to another device, a 

recognized reference method or ‘gold 

standard’, or other procedures not 

commonly used, and/or clinical criteria 

for diagnosis.’’ Using the input from that 

meeting, a draft guidance document was 

developed discussing some statistically 

valid approaches to reporting results 

from evaluation studies for new 

diagnostic devices. The draft guidance 

was released for public comment on 

March 12, 2003. 

Following publication of the draft 

guidance, 11 comments were submitted 

to FDA. Overall, comments were 

favorable and requested that additional 

information be included in the final 

guidance. We reviewed the comments 

and took their suggestions into 

consideration in writing this guidance, 

including consideration of the 

comments requesting greater attention 

to the use of standard terminology. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on reporting results 

from studies evaluating diagnostic tests. 

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 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. To receive ‘‘Statistical 

Guidance on Reporting Results from 

Studies Evaluating Diagnostic Tests,’’

you may either send an e-mail request 

to dsmica@fda.hhs.gov to receive an 

electronic copy of the document or send 

a fax request to 240–276–3151 to receive 

a hard copy. Please use the document 

number 1620 to identify the guidance 

you are requesting. 

CDRH maintains an entry on the 

Internet for easy access to information 

including text, graphics, and files that 

may be downloaded to a personal 

computer with Internet access. Updated 

on a regular basis, the CDRH home page 

includes device safety alerts, Federal 

Register reprints, information on 

premarket submissions (including lists 

of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

Internet site at http://www.fda.gov/ 

ohrms/dockets. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501–

3520). The collections of information in 

21 CFR part 807 have been approved 

under OMB Control No. 0910–0120; and 

the collections of information in 21 CFR 

part 814 have been approved under 

OMB Control No. 0910–0231. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: March 2, 2007. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. E7–4453 Filed 3–12–07; 8:45 am] 

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