[Federal Register Volume 66, Number 55 (Wednesday, March 21, 2001)]
[Rules and Regulations]
[Pages 15796-15798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6938]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 21 CFR Part 880

[Docket No. 00P-1554]


Medical Device; Exemption From Premarket Notification; Class II 
Devices; Pharmacy Compounding Systems

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is publishing an order 
granting a petition requesting exemption from the premarket 
notification requirements for pharmacy compounding systems classified 
within the intravascular administration set, with certain limitations. 
This rule will exempt from premarket notification pharmacy compounding 
systems classified within the intravascular administration set and 
establishes a guidance document as a special control for this device. 
FDA is publishing this order in accordance with the Food and Drug 
Administration Modernization Act of 1997 (FDAMA).

DATES: This rule is effective March 21, 2001.

FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for 
Devices and Radiological Health (HFZ-404), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
1190.

SUPPLEMENTARY INFORMATION:

I. Statutory Background

    Under section 513 of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360c), FDA must classify devices into one of three 
regulatory classes: Class I, class II, or class III. FDA classification 
of a device is determined by the amount of regulation necessary to 
provide a reasonable assurance of safety and effectiveness. Under the 
Medical Device Amendments of 1976 (the 1976 amendments (Public Law 94-
295)), as amended by the Safe Medical Devices Act of 1990 (the SMDA 
(Public Law 101-629)), devices are to be classified

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into class I (general controls) if there is information showing that 
the general controls of the act are sufficient to assure safety and 
effectiveness; into class II (special controls), 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 such assurance; and into class 
III (premarket approval), if there is insufficient information to 
support classifying a device into class I or class II and the device is 
a life-sustaining or life-supporting device or is for a use that is of 
substantial importance in preventing impairment of human health, or 
presents a potential unreasonable risk of illness or injury.
    Most generic types of devices that were on the market before the 
date of the 1976 amendments (May 28, 1976) (generally referred to as 
preamendments devices) have been classified by FDA under the procedures 
set forth in section 513(c) and (d) of the act through the issuance of 
classification regulations into one of these three regulatory classes. 
Devices introduced into interstate commerce for the first time on or 
after May 28, 1976, (generally referred to as postamendments devices) 
are classified through the premarket notification process under section 
510(k) of the act (21 U.S.C. 360(k)). Section 510(k) of the act and the 
implementing regulations (21 CFR part 807) require persons who intend 
to market a new device to submit a premarket notification report 
(510(k)) containing information that allows FDA to determine whether 
the new device is ``substantially equivalent'' within the meaning of 
section 513(i) of the act to a legally marketed device that does not 
require premarket approval.
    On November 21, 1997, the President signed into law FDAMA (Public 
Law 105-115). Section 206 of FDAMA, in part, added a new section 510(m) 
to the act. Section 510(m)(1) of the act requires FDA, within 60 days 
after enactment of FDAMA, to publish in the Federal Register a list of 
each type of class II device that does not require a report under 
section 510(k) of the act to provide reasonable assurance of safety and 
effectiveness. Section 510(m) of the act further provides that a 510(k) 
will no longer be required for these devices upon the date of 
publication of the list in the Federal Register. FDA published that 
list in the Federal Register of January 21, 1998 (63 FR 3142).
    Section 510(m)(2) of the act provides that 1 day after date of 
publication of the list under section 510(m)(1) of the act, FDA may 
exempt a device on its own initiative, or upon petition of an 
interested person, if FDA determines that a 510(k) is not necessary to 
provide reasonable assurance of the safety and effectiveness of the 
device. This section requires FDA to publish in the Federal Register a 
notice of intent to exempt a device, or of the petition, and to provide 
a 30-day comment period. Within 120 days of publication of this 
document, FDA must publish in the Federal Register its final 
determination regarding the exemption of the device that was the 
subject of the notice. If FDA fails to respond to a petition under this 
section within 180 days of receiving it, the petition shall be deemed 
granted.

II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether 
a 510(k) is necessary to provide reasonable assurance of the safety and 
effectiveness of a class II device. These factors are discussed in the 
guidance that the agency issued on February 19, 1998, entitled 
``Procedures for Class II Device Exemptions from Premarket 
Notification, Guidance for Industry and CDRH Staff.'' That guidance can 
be obtained through the Internet on the CDRH home page at http://www.fda.gov/cdrh or by facsimile through CDRH Facts-on-Demand at 1-800-
899-0381 or 301-827-0111. Specify ``159'' when prompted for the 
document shelf number.

III. Petition

    On October 3, 2000, FDA received a petition requesting an exemption 
from premarket notification for pharmacy compounding systems classified 
within the intravascular administration set. Pharmacy compounding 
systems are currently classified under 21 CFR 880.5440 as an 
intravascular administration set. In the Federal Register of December 
15, 2000 (65 FR 78494), FDA published a notice announcing that this 
petition had been received and provided opportunity for interested 
persons to submit comments on the petition by January 16, 2001. FDA 
received two comments opposing an exemption from premarket notification 
for these devices.
    These comments objected that these devices presented risks to the 
patient, who may receive an inaccurate formula due to programming 
errors. One comment pointed out that the American Society of Hospital 
Pharmacists (ASHP) recommended that pharmacists should verify that a 
device they intend to use is cleared by FDA in a 510(k) as evidence of 
compliance with regulatory requirements. One comment further stated 
``Class I device exemption would eliminate the requirement for 
reporting changes in device design, manufacturing and quality control 
systems for FDA review prior to implementation under the provisions of 
21 CFR 807.81(3)(i).'' Both comments objected that the petitioner did 
not establish that the device met FDA criteria for exemption from 
premarket notification.
    FDA disagrees with these comments. These devices will remain in 
Class II and will be subject to general controls other than premarket 
notification such as labeling requirements and the quality systems 
regulation. In addition, in this rule, FDA is establishing a guidance 
document entitled ``Class II Special Controls Guidance Document: 
Pharmacy Compounding Systems; Final Guidance for Industry and FDA 
Reviewers'' as a special control for this device. This guidance 
document will address the remaining regulatory requirements for these 
devices. FDA believes that the remaining general controls and the 
guidance document will address any risks to health, such as programming 
errors, presented by these devices. This exemption is limited to the 
pharmacy compounding system as described, and is also subject to the 
general limitations on exemptions from premarket notification for 
therapeutic devices as described in 21 CFR 880.9. Therefore, 
manufacturers will have to submit premarket notifications for any 
changes that bring the device outside of the exempt category. FDA does 
not believe that maintaining a requirement for premarket notification 
is necessary to ensure compliance with the ``existing requirements'' 
referenced in the ASHP publication.
    FDA has determined that pharmacy compounding systems classified 
within the intravascular administration set meet the criteria for 
exemption from the notification requirements. FDA believes that the 
requirements outlined in the guidance document will provide reasonable 
assurance of the safety and effectiveness of these devices.

IV. Electronic Access

    In order to receive ``Class II Special Controls Guidance Document: 
Pharmacy Compounding Systems; Final Guidance for Industry and FDA 
Reviewers'' via your fax machine, call the CDRH Facts-on-Demand system 
at 800-899-0381 or 301-827-0111 from a touchtone telephone. At the 
first voice prompt press 1 to access DSMA Facts, at second voice prompt 
press 2, and then enter the document number (1326) followed by the 
pound sign (#). Then follow the remaining voice prompts to complete 
your request. Persons interested in

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obtaining a copy of the guidance may also do so 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 access to the Internet. Updated on a regular 
basis, the CDRH home page includes, ``Class II Special Controls 
Guidance Document: Pharmacy Compounding Systems; Final Guidance for 
Industry and FDA Reviewers,'' device safety alerts, Federal Register 
reprints, information on premarket submissions (including lists of 
approved applications and manufacturers' addresses), small 
manufacturers' assistance, information on video conferencing and 
electronic submissions, mammography matters, and other device-oriented 
information. The CDRH home page may be accessed at www.fda.gov/cdrh.

V. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) 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. Because this rule will relieve a burden and simplify 
the marketing of these devices, the agency certifies that the final 
rule will not have a significant economic impact on a substantial 
number of small entities. Therefore, under the Regulatory Flexibility 
Act, no further analysis is required.

VII. 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.

VIII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rules 
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.

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 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 880.5440 is amended by revising paragraph (b) to read as 
follows:


Sec. 880.5440  Intravascular administration set.

* * * * *
    (b) Classification. Class II (special controls). The special 
control for pharmacy compounding systems within this classification is 
the FDA guidance document entitled ``Class II Special Controls Guidance 
Document: Pharmacy Compounding Systems; Final Guidance for Industry and 
FDA Reviewers.'' Pharmacy compounding systems classified within the 
intravascular administration set are exempt from the premarket 
notification procedures in subpart E of this part and subject to the 
limitations in Sec. 880.9.

    Dated: March 12, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-6938 Filed 3-20-01; 8:45 am]
BILLING CODE 4160-01-S