[Federal Register Volume 72, Number 202 (Friday, October 19, 2007)]
[Notices]
[Pages 59297-59298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20635]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0327]


Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Remote Medication 
Management System; 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: Remote Medication Management System.'' This guidance 
document describes a means by which remote medication management 
systems may comply with the requirement of special controls for class 
II devices. Elsewhere in this issue of the Federal

[[Page 59298]]

Register, FDA is publishing a final rule to classify remote medication 
management systems into class II (special controls). This guidance 
document is being immediately implemented as the special control for 
remote medication management systems, but it remains subject to comment 
in accordance with the agency's good guidance practices (GGPs).

DATES: Submit written or electronic comments on the 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 ``Class II Special Controls Guidance Document: Remote 
Medication Management 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 
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 either http://www.fda.gov/dockets/ecomments or http://www.regulations.gov. Identify comments with the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Richard Chapman, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-2585.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying remote medication management systems 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 remote 
medication management 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 time frames 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. Thus, 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 good guidance 
practices regulation (Sec.  10.115). The guidance represents the 
agency's current thinking on remote medication management 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: Remote 
Medication Management System,'' you may either send an e-mail request 
to [email protected] 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 1621 to identify the guidance you are requesting.
    Persons interested in obtaining a copy of the guidance may 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 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 (the PRA) (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 807, subpart E 
have been approved under OMB control number 0910-0120; the collections 
of information in 21 CFR part 820 have been approved under OMB control 
number 0910-0073; and the collections of information in 21 CFR part 801 
have been approved 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 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: October 3, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-20635 Filed 10-18-07; 8:45 am]
BILLING CODE 4160-01-S