[Federal Register: October 31, 2003 (Volume 68, Number 211)]
[Page 62089-62090]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003D-0221]

Guidance for Industry and FDA Staff; Class II Special Controls 
Guidance Document: Endotoxin Assay; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Class II Special Controls 
Guidance Document: Endotoxin Assay.'' This guidance document describes 
a means by which an endotoxin assay may comply with the requirement of 
special controls for class II devices. Elsewhere in this issue of the 
Federal Register, FDA is publishing a final rule to classify the 
endotoxin assay into class II (special controls). This guidance 
document is effective immediately as the special control for the 
endotoxin assay, but it remains subject to comment in accordance with 
the agency's good guidance practices (GGPs).

DATES: Submit written or electronic comments on agency guidances at any 

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``Class II Special Control 
Guidance Document: Endotoxin Assay'' 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 two self-addressed adhesive 
labels to assist that office in processing your request, or fax your 
request to 301-443-8818. 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Comments should be identified 
with the docket number found in brackets in the heading of this 

FOR FURTHER INFORMATION CONTACT: Freddie M. Poole, Center for Devices 
and Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-2096.


I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying the endotoxin assay into class II (special 
controls) under section 513(f)(2) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360c(f)(2)). This guidance document 
will serve as the special control for the endotoxin assay. Section 
513(f)(2) of the act provides that any person who submits a premarket 
notification under section 510(k) of the act (21 U.S.C. 360(k)) for a 
device that has not previously been classified may, within 30 days 
after receiving an order classifying the device in class III under 
section 513(f)(1) of the act, request that FDA classify the device 
under the criteria set forth in section 513(a)(1) of the act. FDA 
shall, within 60 days of receiving such a request, classify the device 
by written order. This classification shall be the initial 
classification of the device. Within 30 days after the issuance of an 
order classifying the device, FDA will publish a notice in the Federal 
Register announcing such classification.
    Because of the timeframes established by section 513(f)(2) of the 
act, FDA has determined, under 21 CFR 10.115(g)(2), that it is not 
feasible to allow for public participation before issuing this guidance 
as a final guidance document. Therefore, FDA is issuing this guidance 
document as a level 1 guidance document that is immediately in effect. 
FDA will consider any comments that are received in response to this 
notice to determine whether to amend the guidance document.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's GGPs regulation 
(21 CFR 10.115). The guidance represents the agency's current thinking 
on endotoxin assays. 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 statutes and regulations.

III. Electronic Access

    To receive ``Class II Special Controls Guidance Document: Endotoxin 

[[Page 62090]]

by fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 
301-827-0111 from a touch-tone telephone. Press 1 to enter the system. 
At the second voice prompt, press 1 to order a document. Enter the 
document number (1222) followed by the pound sign (). Follow 
the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so by using the Internet. 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 home page may be accessed at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available on the Division of Dockets 
Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 USC 3501-3520) (the PRA). The 
collections of information addressed in the guidance document have been 
approved by OMB in accordance with the PRA under the regulations 
governing premarket notification submissions (21 CFR part 807, subpart 
E, OMB Control No. 0910-0120). The labeling provisions addressed in the 
guidance have been approved by OMB under the PRA under OMB control 
number 0910-0485.

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 to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
 or two paper copies of any written 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: October 17, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-27393 Filed 10-30-03; 8:45 am]