[Federal Register Volume 65, Number 242 (Friday, December 15, 2000)]
[Notices]
[Pages 78494-78495]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-31961]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00P-1554]


Medical Devices; Exemptions From Premarket Notification; Class II 
Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a notice 
announcing that it has received a petition requesting exemption from 
the premarket notification requirements for pharmacy compounding 
systems classified within the intravascular administration set, a class 
II device (special controls). FDA is publishing this notice in order to 
obtain comments on this petition in accordance with procedures 
established by the Food and Drug Administration Modernization Act of 
1997 (FDAMA).

DATES: Submit written comments by January 16, 2001.

ADDRESSES: Submit written comments on this notice to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

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 into class I 
(general controls) if there is information showing that the general 
controls of the act are sufficient to ensure 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 
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 the 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). In the 
Federal Register of November 3, 1998 (63 FR 59222), FDA published a 
final rule codifying these exemptions.
    Section 510(m)(2) of the act provides that, 1 day after date of 
publication of the list under section 510(m)(1), 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

[[Page 78495]]

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 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

    FDA received the following petition requesting an exemption from 
premarket notification for class II devices: Baxter Healthcare, 
Pharmacy Compounding Systems Classified within the Intravascular 
administration set, 21 CFR 880.5440.

IV. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this petition by January 16, 
2001. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
petition and received comments may be seen in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 5, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-31961 Filed 12-14-00; 8:45 am]
BILLING CODE 4160-01-F