[Federal Register Volume 65, Number 114 (Tuesday, June 13, 2000)]
[Rules and Regulations]
[Pages 37041-37043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14698]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 880
[Docket No. 99N-2099]
General Hospital and Personal Use Devices; Classification of the
Subcutaneous, Implanted, Intravascular Infusion Port and Catheter and
the Percutaneous, Implanted, Long-term Intravascular Catheter
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
subcutaneous, implanted, intravascular (IV) infusion port and catheter,
and the percutaneous, implanted, long-term IV catheter intended for
repeated vascular access into class II (special controls). This action
is being taken to establish sufficient regulatory controls that will
provide reasonable assurance of the safety and effectiveness of these
devices.
DATES: This rule is effective July 13, 2000.
FOR FURTHER INFORMATION CONTACT: M. Patricia Cricenti, Center for
Devices and Radiological Health (HFZ-480), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
1287.
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301
et. seq.), as amended by the Medical Device Amendments of 1976 (the
1976 amendments) (Public Law 94-295), the Safe Medical Devices Act of
1990 (the SMDA) (Public Law 101-629), and the Food and Drug
Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115),
established a comprehensive system for the regulation of medical
devices intended for human use. Section 513 of the act (21 U.S.C. 360c)
established three categories (classes) of devices, depending on the
regulatory controls needed to provide reasonable assurance of their
safety and effectiveness. The three categories of devices are class I
(general controls), class II (special controls), and class III
(premarket approval).
Under section 513 of the act, devices that were in commercial
distribution before May 28, 1976 (the date of enactment of the 1976
amendments), generally referred to as preamendments devices, are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
Devices that were not in commercial distribution prior to May 28,
1976, generally referred to as postamendments devices, are classified
automatically by statute (section 513(f) of the act) into class III
without any FDA rulemaking process. Those devices remain in class III
and require premarket approval, unless and until: (1) The device is
reclassified into class I or II; (2) FDA issues an order classifying
the device into class I or II in accordance with section 513(f)(2) of
the act, as amended by FDAMA; or (3) 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 previously offered devices by means of
premarket notification procedures in section 510(k) of the act
[[Page 37042]]
(21 U.S.C. 360(k)) and 21 CFR part 807 of the regulations.
A preamendments device that has been classified into class III may
be marketed, by means of premarket notification procedures, without
submission of a premarket approval application (PMA) until FDA issues a
final regulation under section 515(b) of the act (21 U.S.C. 360e(b))
requiring premarket approval.
Consistent with the act and the regulations, FDA consulted with the
General Hospital and Personal Use Devices Panel (the Panel), an FDA
advisory committee, regarding the classification of these devices.
II. Regulatory History of the Devices
In the Federal Register of October 1, 1999 (64 FR 53294), FDA
issued a proposed rule to classify the subcutaneous, implanted, IV
infusion port and catheter, and the percutaneous, implanted, long-term
IV catheter intended for repeated vascular access into class II.
Interested persons were given until December 30, 1999, to comment on
the proposed regulation.
In 1980, when other general hospital and personal use devices were
classified (45 FR 69678, October 21, 1980), FDA was not aware that
these two vascular access devices (the subcutaneous, implanted, IV
infusion port and catheter and the percutaneous, implanted, long-term
IV catheter) intended for repeated vascular access were preamendments
devices, and inadvertently omitted classifying them.
FDA received one comment from a manufacturer who concurred with the
proposed rule to classify the devices into class II. FDA agrees with
the comment.
III. Summary of Final Rule
Based on the Panel's recommendation (Ref. 1), FDA is classifying
the subcutaneous, implanted, IV infusion port and catheter and the
percutaneous, implanted, long-term IV catheter intended for repeated
vascular access into class II. FDA has determined that existing
premarket notification FDA guidance documents, ``Guidance on 510(k)
Submissions for Implanted Infusion Ports'' (Ref. 2) and ``Guidance on
Premarket Notification [510(k)] Submission for Short-Term and Long-Term
Intravascular Catheters'' (Ref. 3) are adequate special controls
capable of providing reasonable assurance of safety and effectiveness
with regard to the identified risks to health of these devices. The
Panel also recommended including the prescription statement
(Sec. 801.109 (21 CFR 801.109)) as a special control. Because this
prescription statement is already required by Sec. 801.109, FDA
believes it is unnecessary to list prescription labeling as a special
control for these devices.
IV. Summary of the Reasons for the Recommendations
Therefore, under section 513 of the act, FDA is adopting the
summary of reasons for the Panel's recommendation and the summary of
data upon which the Panel's recommendation is based (Ref. 1), and it is
also adopting the assessment of the risks to public health stated in
the proposed rule published on October 1, 1999. Furthermore, FDA is
issuing this final rule which classifies the generic types of devices,
the subcutaneous, implanted, IV infusion port and catheter, and the
percutaneous, implanted, long-term IV catheter intended for repeated
vascular access into class II.
V. Environmental Impact
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. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VI. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866, and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as
amended by subtitle D of the Small Business Regulatory Fairness Act of
1996 (Public Law 104-121)), 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 consistent
with the regulatory philosophy and principles identified in the
Executive Order. In addition, the final rule is not a significant
regulatory action as defined by the Executive Order and so is not
subject to review under 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. As unclassified devices, these devices are already
subject to premarket notification and the general labeling provisions
of the act. FDA, therefore, believes that classification in class II
with premarket notification guidances as special controls will impose
no significant economic impact on any small entities. The agency
therefore certifies that this final rule will not have a significant
economic impact on a substantial number of small entities. In addition,
this final rule will not impose costs of $100 million or more on either
the private sector or State, local, and tribal governments in the
aggregate, and therefore a summary statement or analysis under section
202(a) of the Unfunded Mandates Reform Act of 1995 is not required.
VII. Federalism
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 order and, consequently, a federalism
summary impact statement is not required.
VIII. Paperwork Reduction Act of 1995
FDA concludes that this final rule contains no collections of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.
IX. References
The following references have been placed on display in the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. These references may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. General Hospital and Personal Use Devices Panel, thirtieth
meeting, transcript, March 11, 1996.
2. ``Guidance on 510(k) Submissions for Implanted Infusion Ports,''
FDA, October 1990.
3. ``Guidance on Premarket Notification [510(k)] Submission for
Short-Term and Long-Term Intravascular Catheters,'' FDA, March 1995.
List of Subjects in 21 CFR Part 880
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner
[[Page 37043]]
of Food and Drugs, 21 CFR part 880 is amended as follows:
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
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.
2. Section 880.5965 is added to subpart F to read as follows:
Sec. 880.5965 Subcutaneous, implanted, intravascular infusion port and
catheter.
(a) Identification. A subcutaneous, implanted, intravascular
infusion port and catheter is a device that consists of a subcutaneous,
implanted reservoir that connects to a long-term intravascular
catheter. The device allows for repeated access to the vascular system
for the infusion of fluids and medications and the sampling of blood.
The device consists of a portal body with a resealable septum and
outlet made of metal, plastic, or combination of these materials and a
long-term intravascular catheter is either preattached to the port or
attached to the port at the time of device placement. The device is
available in various profiles and sizes and can be of a single or
multiple lumen design.
(b) Classification. Class II (special controls) Guidance Document:
``Guidance on 510(k) Submissions for Implanted Infusion Ports,'' FDA
October 1990.
3. Section 880.5970 is added to subpart F to read as follows:
Sec. 880.5970 Percutaneous, implanted, long-term intravascular
catheter.
(a) Identification. A percutaneous, implanted, long-term
intravascular catheter is a device that consists of a slender tube and
any necessary connecting fittings, such as luer hubs, and accessories
that facilitate the placement of the device. The device allows for
repeated access to the vascular system for long-term use of 30 days or
more, and it is intended for administration of fluids, medications, and
nutrients; the sampling of blood; and monitoring blood pressure and
temperature. The device may be constructed of metal, rubber, plastic,
composite materials, or any combination of these materials and may be
of single or multiple lumen design.
(b) Classification. Class II (special controls) Guidance Document:
``Guidance on Premarket Notification [510(k)] Submission for Short-Term
and Long-Term Intravascular Catheters.''
Dated: May 23, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 00-14698 Filed 6-12-00; 8:45 am]
BILLING CODE 4160-01-F