[Federal Register Volume 71, Number 31 (Wednesday, February 15, 2006)]
[Notices]
[Pages 7975-7976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-2142]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0505]


Guidance for Industry and Food and Drug Administration; Class II 
Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure 
Measurement System; 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: Implantable Intra-Aneurysm Pressure Measurement 
System.'' This guidance document describes a means by which the 
implantable intra-aneurysm pressure measurement system 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 these device types into class II (special controls). This 
guidance document is immediately in effect as the special control for 
implantable intra-aneurysm pressure measurement

[[Page 7976]]

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: Implantable Intra-Aneurysm Pressure Measurement 
System'' 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: Nelson Anderson, Center for Devices 
and Radiological Health (HFZ-450), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8282, ext. 171.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying an implantable intra-aneurysm pressure 
measurement system 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 implantable intra-aneurysm pressure measurement 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 into 
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 issuance of an order classifying the device, 
FDA must publish a notice in the Federal Register announcing such 
classification. On August 4, 2005, FDA classified the implantable 
intra-aneurysm measurement system into class III, because it was not 
substantially equivalent to a device that was introduced into 
interstate commerce for commercial distribution before May 28, 1976. On 
August 9, 2005, CardioMEMS, Inc., submitted a petition requesting 
classification of the CardioMEMS EndoSensor System under section 
513(f)(2) of the act to be classified into class II. After review of 
the information submitted in the petition, FDA determined that the 
CardioMEMS EndoSensor System can be classified into class II with the 
establishment of special controls. FDA believes these special controls 
will provide reasonable assurance of the safety and effectiveness of 
the device. 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 implantable intra-aneurysm pressure measurement 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: 
Implantable Intra-Aneurysm Pressure Measurement System'' by fax 
machine, 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 (1589) 
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 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 in this guidance document have been 
approved under OMB Control. No. 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 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: February 6, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-2142 Filed 2-15-06; 8:45 am]
BILLING CODE 4160-01-S