[Federal Register Volume 66, Number 95 (Wednesday, May 16, 2001)]
[Rules and Regulations]
[Pages 27023-27025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12227]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 864 and 876

[Docket No. 01P-0087]


Gastroenterology-Urology Devices; Classification of Tissue 
Culture Media for Human Ex Vivo Tissue and Cell Culture Processing 
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying tissue 
culture media for human ex vivo tissue and cell culture processing 
applications into class II (special controls). The special control that 
will apply to this device is a guidance document entitled ``Class II 
Special Controls Guidance Document: Tissue Culture Media for Human Ex 
Vivo Tissue and Cell Culture Processing Applications; Final Guidance 
for Industry and FDA Reviewers.'' The agency is taking this action in 
response to a petition submitted under the Federal Food, Drug, and 
Cosmetic Act (the act) as amended by the Medical Device Amendments of 
1976, the Safe Medical Devices Act of 1990, and the Food and Drug 
Administration Modernization Act of 1997. The agency is classifying 
these devices into class II (special controls) in order to provide a 
reasonable assurance of the safety and effectiveness of the devices.

DATES: This rule is effective May 16, 2001.

FOR FURTHER INFORMATION CONTACT: Carolyn Y. Neuland, Center for Devices 
and Radiological Health (HFZ-473), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1220.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of 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, 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 and until the device is classified or reclassified 
into class I or 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 
previously marketed devices by means of premarket notification 
procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR 
part 807 of the FDA 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. Within 30 days after the issuance of an order classifying the 
device, FDA must publish a notice in the Federal Register announcing 
such classification.
    In accordance with section 513(f)(1) of the act, FDA issued an 
order on December 5, 2000, classifying the Dulbecco's Modified Eagle 
medium for human ex vivo tissue and cell culture processing 
applications 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 December 19, 2000, FDA filed a petition submitted by Life 
Technologies, Inc., requesting classification of the Dulbecco's 
Modified Eagle medium for human ex vivo tissue and cell culture 
processing applications into class II under section 513(f)(2) of the 
act. After review of the information submitted in the petition, FDA 
determined that the Dulbecco's Modified Eagle medium for human ex vivo 
tissue and cell culture processing applications can be classified in 
class II with the establishment of special controls. The solutions are 
indicated for use in human ex vivo tissue and cell culture processing 
applications. FDA believes that class II special controls, in addition 
to the general controls, will provide reasonable assurance of the 
safety and effectiveness of the device for this intended use.
    In addition to the general controls of the act, the Dulbecco's 
Modified Eagle medium for human ex vivo tissue and cell culture 
processing applications is subject to a special control guidance 
document entitled ``Class II Special Controls Guidance Document: Tissue 
Culture Media for Human Ex Vivo Tissue and Cell Culture Processing 
Applications; Final Guidance for Industry and FDA Reviewers.''
    Section 510(m) of the act provides that FDA may exempt a class II 
device from the premarket notification requirements 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. FDA has determined that premarket 
notification is necessary to provide reasonable assurance of the safety 
and effectiveness of this type of device for this intended use and, 
therefore, the device is not exempt from the premarket notification 
requirements. FDA review of bench data and labeling will ensure that 
minimum levels of performance for both safety and effectiveness are 
addressed before marketing clearance. Thus, persons who intend to 
market this device for this intended use must submit to FDA a premarket 
notification submission containing information on the device before 
marketing the device.
    On February 16, 2001, FDA issued an order to the petitioner 
classifying the Dulbecco's Modified Eagle medium for human ex vivo 
tissue and cell culture processing applications, and substantially 
equivalent devices of this generic type, into class II under the 
generic name, tissue culture media for

[[Page 27024]]

human ex vivo tissue and cell culture processing applications. FDA 
identifies this generic type of device as tissue culture media for 
human ex vivo tissue and cell culture processing applications 
consisting of cell and tissue culture media and components that are 
composed of chemically defined components (e.g., amino acids, vitamins, 
inorganic salts) that are essential for the ex vivo development, 
survival, and maintenance of tissues and cells of human origin. The 
solutions are indicated for use in human ex vivo tissue and cell 
culture processing applications. This order also identified as a 
special control applicable to this device a guidance document entitled 
``Class II Special Controls Guidance Document: Tissue Culture Media for 
Human Ex Vivo Tissue and Cell Culture Processing Applications; Final 
Guidance for Industry and FDA Reviewers.''
    FDA is codifying this device by adding Sec. 876.5885. FDA is also 
amending 21 CFR 864.2220 Synthetic cell and tissue culture media and 
components, to clarify that the device described in that section does 
not include tissue culture media for human ex vivo tissue and cell 
culture processing applications.

II. Electronic Access

    In order to receive the document entitled, ``Class II Special 
Controls Guidance Document: Tissue Culture Media for Human Ex Vivo 
Tissue and Cell Culture Processing Applications; 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 touch-tone 
telephone. At the first voice prompt press 1 to access DSMA Facts, at 
second voice prompt press 2, and then enter the document number 1325. 
Then follow the remaining voice prompts to complete your request. 
Persons interested in 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 the document entitled 
``Class II Special Controls Guidance Document: Tissue Culture Media for 
Human Ex Vivo Tissue and Cell Culture Processing Applications; 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.

III. 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.

IV. 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 it 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. FDA knows of only one manufacturer of this type of 
device. Classification of these devices in class II will relieve this 
manufacturer of the device 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 market place by 
lowering their costs. The agency, therefore, certifies that this 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 of anticipated costs and 
benefits before proposing any rule that may result in an expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million in any one year (adjusted annually for 
inflation). The Unfunded Mandates Reform Act does not require FDA to 
prepare a statement of costs and benefits for the final rule, because 
the final rule is not expected to result in any 1-year expenditure that 
would exceed$100 million.

V. 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, or 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.

VI. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

List of Subjects

21 CFR Part 864

    Biologics, Blood, Laboratories, Medical devices, Packaging and 
containers.

21 CFR Part 876

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
864 and 876 are amended as follows:

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

    1. The authority citation for 21 CFR part 864 continues to read as 
follows:

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

    2. Section 864.2220 is amended by revising paragraph (a) to read as 
follows:


Sec. 864.2220  Synthetic cell and tissue culture media and components

    (a) Identification. Synthetic cell and tissue culture media and 
components are substances that are composed entirely of defined 
components (e.g., amino acids, vitamins, inorganic salts) that are 
essential for the survival and development of cell lines of humans and 
other animals. This does not

[[Page 27025]]

include tissue culture media for human ex vivo tissue and cell culture 
processing applications as described in Sec. 876.5885 of this chapter.
* * * * *

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

    1. The authority citation for 21 CFR part 876 continues to read as 
follows:

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

    2. Section 876.5885 is added to subpart F to read as follows:


Sec. 876.5885  Tissue culture media for human ex vivo tissue and cell 
culture processing applications.

    (a) Identification. Tissue culture media for human ex vivo tissue 
and cell culture processing applications consist of cell and tissue 
culture media and components that are composed of chemically defined 
components (e.g., amino acids, vitamins, inorganic salts) that are 
essential for the ex vivo development, survival, and maintenance of 
tissues and cells of human origin. The solutions are indicated for use 
in human ex vivo tissue and cell culture processing applications.
    (b) Classification. Class II (special controls): FDA guidance 
document, ``Class II Special Controls Guidance Document: Tissue Culture 
Media for Human Ex Vivo Processing Applications; Final Guidance for 
Industry and FDA Reviewers.''

    Dated: May 7, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-12227 Filed 5-15-01; 8:45 am]
BILLING CODE 4160-01-S