[Federal Register Volume 72, Number 202 (Friday, October 19, 2007)]
[Rules and Regulations]
[Pages 59175-59177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20633]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. 2007N-0328]


Medical Devices; General Hospital and Personal Use Devices; 
Classification of Remote Medication Management System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
remote medication management systems into class II (special controls). 
Elsewhere in this issue of the Federal Register, FDA is announcing the 
availability of a guidance document entitled, ``Guidance for Industry 
and Food and Drug Administration Staff; Class II Special Controls 
Guidance Document: Remote Medication Management System,'' which will 
serve as the special control for this device type. The agency is 
classifying this device type into class II (special controls) in order 
to provide a reasonable assurance of safety and effectiveness of these 
devices.

DATES: This final rule is effective November 19, 2007. The 
classification was effective June 13, 2007.

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. What is the Background of This Rulemaking?

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360c(f)(1)), devices that were not in 
commercial distribution before May 28, 1976, the date of enactment of 
the Medical Device Amendments of 1976 (the amendments), generally 
referred to as postamendments devices, are classified automatically by 
statute into class III without any FDA rulemaking process. These 
devices remain in class III and require premarket approval, unless the 
device is classified or reclassified into class I or class II, or FDA 
issues an order finding the device to be substantially equivalent, in 
accordance with section 513(i) of the act, to a predicate device that 
does not require premarket approval. The agency determines whether new 
devices are substantially equivalent to predicate devices by means of 
premarket notification procedures in section 510(k) of the act (21 
U.S.C. 360(k)) and part 807 (21 CFR part 807) of FDA's regulations.
    Section 513(f)(2) of the act provides that any person who submits a 
premarket notification under section 510(k) of the act 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 type. Within 30 days after the issuance of an order classifying 
the device, FDA must publish a notice in the Federal Register 
announcing such classification (section 513(f)(2) of the act).
    In accordance with section 513(f)(1) of the act, FDA issued an 
order on September 20, 2006, classifying the INRange Remote Medication 
Management System in class III because it was not substantially 
equivalent to a device that was introduced or delivered for 
introduction into interstate commerce for commercial distribution 
before May 28, 1976, or a device that was subsequently reclassified 
into class I or class II. On September 25, 2006, INRange Systems, Inc., 
submitted a petition requesting classification of the INRange Remote 
Medication Management System under section 513(f)(2) of the act. The 
manufacturer recommended that the device be classified into class II 
(Ref. 1).
    In accordance with section 513(f)(2) of the act, FDA reviewed the 
petition in order to classify the device under the criteria for 
classification set forth in 513(a)(1) of the act. Devices are to be 
classified into class II if general controls, by themselves, are 
insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls to provide reasonable assurance of the safety and 
effectiveness of the device for its intended use. After review of the 
information submitted in the petition, FDA determined that remote 
medication management systems can be classified into class II with the 
establishment of special controls. FDA believes that these special 
controls, in addition to general controls, are adequate to provide 
reasonable assurance of the safety and effectiveness of the device. The 
device is assigned the generic name ``Remote Medication Management 
System.'' A remote medication management system is a device composed of 
clinical and communications software, a medication delivery unit, and 
medication packaging. The system is intended to store the patient's 
prescribed medications in a delivery unit, to permit a health care 
professional to remotely schedule the patient's prescribed medications, 
to notify the patient when the prescribed medications are due to be 
taken, to release the prescribed medications to a tray of the delivery 
unit accessible to the patient on the patient's command, and to record 
a history of the event for the health care professional. The system is 
intended for use as an aid to health care professionals in managing 
therapeutic regimens for patients in the home or clinic.
    FDA has identified the following risks to health associated with 
this type of device:
     Improper dosage delivered to patient,
     Cross-contamination of medications--unintended drug 
interactions,
     Compromised information security,
     Failure of the device--inability to deliver medication,
     Electromagnetic interference--electromagnetic emissions 
interfering with other medical devices or electromagnetic 
susceptibility causing the device to function improperly due to 
emissions of other devices, and
     Electrical and mechanical hazards--electrical shock, 
pinching.

[[Page 59176]]

    FDA believes that the class II special controls guidance document 
will aid in mitigating the potential risks to health as described in 
table 1 of this document.

            Table 1.--Risks to Health and Mitigation Measures
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            Identified Risk              Recommended Mitigation Measures
------------------------------------------------------------------------
Improper dosage delivered to patient     Software validation
                                         Simulated use testing
                                         Labeling
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Cross-contamination of medications       Simulated use testing
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Compromised information security         Software validation
                                         Simulated use testing
------------------------------------------------------------------------
Failure of the device                    Software validation
                                         Simulated use testing
                                         Labeling
------------------------------------------------------------------------
Electromagnetic interference             Electromagnetic compatibility
                                         Labeling
------------------------------------------------------------------------
Electrical and mechanical hazards        Electrical and mechanical
                                          safety testing
                                         Labeling
------------------------------------------------------------------------

    FDA believes that the special controls, in addition to general 
controls, address the risks to health identified previously and provide 
reasonable assurances of the safety and effectiveness of the device 
type. Thus, on June 13, 2007, FDA issued an order to the petitioner 
classifying the device into class II. FDA is codifying this 
classification at 21 CFR 880.6315.
    Following the effective date of the final classification rule, 
manufacturers will need to address the issues covered in the special 
controls guidance. However, the manufacturer need only show that its 
device meets the recommendations of the guidance or in some other way 
provides equivalent assurance of safety and effectiveness.
    Section 510(m) of the act provides that FDA may exempt a class II 
device from the premarket notification requirement under section 510(k) 
of the act, if FDA determines that premarket notification is not 
necessary to provide reasonable assurance of the safety and 
effectiveness of the device. For this type of device, FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of the safety and effectiveness of the device and, 
therefore, the type of device is not exempt from premarket notification 
requirements. Persons who intend to market this type of device must 
submit to FDA a premarket notification, prior to marketing the device, 
which contains information about the remote medication management 
system they intend to market.

II. What is the Environmental Impact of This Rule?

    The agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Thus, neither an environmental 
assessment nor an environmental impact statement is required.

III. What is the Economic Impact of This Rule?

    FDA has examined the impacts of the final rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is not a significant regulatory action as defined by 
the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because classification of this device into class II 
will relieve manufacturers of the cost of complying with the premarket 
approval requirements of section 515 of the act (21 U.S.C. 360e), and 
may permit small potential competitors to enter the marketplace by 
lowering their costs, the agency certifies that the final rule will not 
have a significant economic impact on a substantial number of small 
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $127 million, using the most current (2006) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.

IV. Does This Final Rule Have Federalism Implications?

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

[[Page 59177]]

V. How Does This Rule Comply With the Paperwork Reduction Act of 1995?

    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 is not required. Elsewhere in this 
issue of the Federal Register, FDA is issuing a notice announcing the 
guidance for the final rule. This guidance, ``Class II Special Controls 
Guidance Document: Remote Medication Management System,'' references 
previously approved collections of information found in FDA 
regulations.

VI. What References Are on Display?

    The following reference has been placed on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Petition from INRange Systems, Inc., dated September 25, 
2006.

List of Subjects in 21 CFR Part 880

    Medical devices.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
880 is amended as follows:

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

0
1. The authority citation for 21 CFR part 880 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Section 880.6315 is added to subpart G to read as follows:


Sec.  880.6315  Remote Medication Management System.

    (a) Identification. A remote medication management system is a 
device composed of clinical and communications software, a medication 
delivery unit, and medication packaging. The system is intended to 
store the patient's prescribed medications in a delivery unit, to 
permit a health care professional to remotely schedule the patient's 
prescribed medications, to notify the patient when the prescribed 
medications are due to be taken, to release the prescribed medications 
to a tray of the delivery unit accessible to the patient on the 
patient's command, and to record a history of the event for the health 
care professional. The system is intended for use as an aid to health 
care professionals in managing therapeutic regimens for patients in the 
home or clinic.
    (b) Classification. Class II (special controls). The special 
control is: The FDA guidance document entitled ``Guidance for Industry 
and Food and Drug Administration Staff; Class II Special Controls 
Guidance Document: Remote Medication Management System.'' See Sec.  
880.1(e) for availability of this guidance document.

    Dated: October 3, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-20633 Filed 10-18-07; 8:45 am]
BILLING CODE 4160-01-S