[Federal Register: August 25, 2005 (Volume 70, Number 164)]
[Notices]
[Page 49929-49930]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au05-52]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0264]
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Ribonucleic Acid
Preanalytical Systems (Ribonucleic Acid Collection, Stabilization and
Purification Systems for Real Time Polymerase Chain Reaction Used in
Molecular Diagnostic Testing); 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 guidance entitled ``Class II Special Controls
Guidance Document: RNA Preanalytical Systems (RNA Collection,
Stabilization and Purification Systems for RT-PCR used in Molecular
Diagnostic Testing).'' This guidance document describes a means by
which Ribonucleic Acid (RNA) preanalytical systems 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 RNA preanalytical systems into class II (special controls).
This guidance document is immediately in effect as the special control
for RNA preanalytical systems but it remains subject to comment in
accordance with the agency's good guidance practices (GGPs).
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 on a 3.5''
diskette of the guidance document entitled ``Class II Special Controls
Guidance Document: RNA Preanalytical Systems (RNA Collection,
Stabilization and Purification Systems for RT-PCR used in Molecular
Diagnostic Testing)'' 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 self-addressed adhesive label 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://www.fda.gov/dockets/ecomments. Identify comments with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Uwe Scherf, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0496.
SUPPLEMENTARY INFORMATION:
I. Background
Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule classifying RNA preanalytical systems into class II
(special controls) under
[[Page 49930]]
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 RNA preanalytical systems.
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 FDA to 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 must 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
Sec. 10.115(g)(2) (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 GGP regulation
(21 CFR 10.115). The guidance represents the agency's current thinking
on RNA preanalytical systems. 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
To receive ``Class II Special Controls Guidance Document: RNA
Preanalytical Systems (RNA Collection, Stabilization and Purification
Systems for RT-PCR used in Molecular Diagnostic Testing)'' by fax call
the Center for Devices and Radiological Health (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 (1563) followed by the
pound sign (). Follow the remaining voice prompts to complete
your request.
To receive ``Class II Special Controls Guidance Document: RNA
Preanalytical Systems (RNA Collection, Stabilization and Purification
Systems for RT-PCR used in Molecular Diagnostic Testing),'' you may
either send a fax request to 301-443-8818 to receive a hard copy of the
document, or send an e-mail request to gwa@cdrh.fda.gov to receive a
hard copy or an electronic copy. Please use the document number (1563)
to identify the guidance you are requesting.
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 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 contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520).
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 number 0910-0120). The labeling provisions addressed in
the guidance have been approved by OMB under OMB control number 0910-
0485.
V. Comments
Interested persons may submit written or electronic comments
regarding this document to the Division of Dockets Management (see
ADDRESSES). 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: August 9, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-16913 Filed 8-24-05; 8:45 am]
BILLING CODE 4160-01-S