[Federal Register: October 19, 2007 (Volume 72, Number 202)]
[Rules and Regulations]
[Page 59175-59177]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19oc07-6]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
------------------------------------------------------------------------
Identified Risk Recommended Mitigation Measures
------------------------------------------------------------------------
Improper dosage delivered to patient Software validation
Simulated use testing
Labeling
------------------------------------------------------------------------
Cross-contamination of medications Simulated use testing
------------------------------------------------------------------------
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