[Federal Register: February 5, 2003 (Volume 68, Number 24)]

[Rules and Regulations]               

[Page 5825-5827]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr05fe03-14]                         





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DEPARTMENT OF HEALTH AND HUMAN SERVICES





Food and Drug Administration





21 CFR Part 866





[Docket No. 97P-0313]





 

Medical Devices; Reclassification and Codification of Fully 

Automated Short-Term Incubation Cycle Antimicrobial Susceptibility 

Devices From Class III to Class II





AGENCY: Food and Drug Administration, HHS.





ACTION: Final rule.





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SUMMARY: The Food and Drug Administration (FDA) is reclassifying the 

fully automated short-term incubation cycle antimicrobial 

susceptibility device for use in determining in vitro susceptibility of 

bacterial pathogens isolated from clinical specimens from class III to 

class II (special controls). The special control that will apply to 

this device is a guidance document entitled ``Class II Special Controls 

Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; 

Guidance for Industry and FDA.'' The agency is also announcing that it 

has issued an order in the form of a letter to BioMerieux Vitek, Inc., 

reclassifying the device. The agency is classifying this device into 

class II because special controls, in addition to the general controls, 

will provide reasonable assurance of the safety and effectiveness of 

the device and there is sufficient information to establish special 

controls.





DATES: This rule is effective May 6, 2003.





FOR FURTHER INFORMATION CONTACT: Freddie M. Poole, Center for Devices 

and Radiological Health (HFZ-440), Food and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 301-594-2096.





SUPPLEMENTARY INFORMATION:





I. Background (Regulatory Authorities)





    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 (the 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 the 1976 amendments, class II devices were defined as devices 

for which there is insufficient information to show that general 

controls themselves will assure safety and effectiveness, but for which 

there is sufficient information to establish performance standards to 

provide such assurance. The SMDA broadened the definition of class II 

devices to mean devices for which there is insufficient information to 

show that general controls themselves will assure safety and 

effectiveness, but for which there is sufficient information to 

establish special controls to provide such assurance, including 

performance standards, postmarket surveillance, patient registries, 

development and dissemination of guidance, recommendations, and any 

other appropriate actions the agency deems necessary (section 

513(a)(1)(B) of the act).

    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 new section 513(f)(2) 

of the act, as amended by the FDAMA; or (3) FDA issues an order finding 

the device to be substantially equivalent, under 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 (21 U.S.C. 360(k)) and part 807 

of the regulations (21 CFR part 807).

    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.

    Reclassification of postamendments devices is governed by section 

513(f)(3) of the act, formerly section 513(f)(2) of the act. This 

section provides that FDA may initiate the reclassification of a device 

classified into class III under section 513(f)(1) of the act, or the 

manufacturer or importer of a device may petition the Secretary of 

Health and Human Services (the Secretary) for the issuance of an order 

classifying the device in class I or class II. FDA's regulations in 

Sec.  860.134 (21 CFR 860.134) set forth the procedures for the filing 

and review of a petition for reclassification of such class III 

devices. In order to change the classification of the device, it is 

necessary that the proposed new class have sufficient regulatory 

controls to provide reasonable assurance of the safety and 

effectiveness of the device for its intended use.

    The FDAMA added a new section 513(f)(2) to the act which addresses 

classification of postamendments devices. New section 513(f)(2) of the 

act





[[Page 5826]]





provides that, upon receipt of a ``not substantially equivalent'' 

determination, a 510(k) applicant may request FDA to classify a 

postamendments device into class I or class II. Within 60 days from the 

date of such a written request, FDA must classify the device by written 

order. If FDA classifies the device into class I or II, the applicant 

has then received clearance to market the device and it can be used as 

a predicate device for other 510(k)s. It is expected that this process 

will be used for low risk devices. This process does not apply to 

devices that have been classified by regulation into class III, i.e., 

preamendments class III devices, or class III devices for which a PMA 

is appropriate.

    Under section 513(f)(3)(B)(i) of the act, formerly section 

513(f)(2)(B)(i) of the act, the Secretary may, for good cause shown, 

refer a petition to a device classification panel. If a petition is 

referred to a panel, the panel shall make a recommendation to the 

Secretary respecting approval or denial of the petition. Any such 

recommendation shall contain: (1) A summary of the reasons for the 

recommendation, (2) a summary of the data upon which the recommendation 

is based, and (3) an identification of the risks to health (if any) 

presented by the device with respect to which the petition was filed.





II. Recommendation of the Panel





    On July 2, 1997, FDA filed the reclassification petition submitted 

by BioMerieux Vitek, Inc., requesting reclassification of the fully 

automated short-term incubation cycle antimicrobial susceptibility 

devices from class III to class II. FDA consulted with the Microbiology 

Devices Panel (the panel). During an open public meeting on February 

13, 1998, the panel unanimously recommended that FDA reclassify the 

fully automated short-term incubation cycle antimicrobial 

susceptibility device for use in determining in vitro susceptibility of 

bacterial pathogens isolated from clinical specimens from class III to 

class II. The panel identified the risks to health regarding use of 

this device as the reporting of erroneous results, citing that 

insufficient testing of each unique antimicrobial agent with an 

inappropriate clinical and challenge organism, the use of an 

uncalibrated inoculum, or a nonstandardized acceptable error endpoint 

can result in such erroneous reports.

    FDA considered the panel's recommendations and tentatively agreed 

that the generic type of device, the fully automated short-term 

incubation cycle antimicrobial susceptibility device for use in 

determining in vitro susceptibility of bacterial pathogens isolated 

from clinical specimens, be reclassified from class III to class II. 

Subsequently, in the Federal Register of March 8, 2000 (65 FR 12268), 

FDA issued a notice of the panel's recommendation for public comment.

    After reviewing the information in the petition and presenting it 

before the panel, and after considering the panel's recommendation and 

the comments received in response to the notice of panel 

recommendation, FDA issued an order to the petitioner on December 28, 

2001, reclassifying the fully automated short-term incubation cycle 

antimicrobial susceptibility device and substantially equivalent 

devices of this generic type, from class III to class II with the 

implementation of special controls. The special control applicable to 

this generic type of device is a guidance document entitled ``Class II 

Special Controls Guidance Document: Antimicrobial Susceptibility Test 

(AST) Systems; Guidance for Industry and FDA.'' FDA has identified the 

administration of an inappropriate antimicrobial agent to the patient 

as the risk to health associated with use of this device. The guidance 

document contains sections that discuss the use of appropriate 

challenge strains; standardized preparation of inoculum; the 

application of ``acceptable error'' as a range with confidence 

intervals; and appropriate clinical performance testing. In this way, 

the guidance will minimize the sources of erroneous reporting 

associated with the fully automated short-term incubation cycle 

antimicrobial susceptibility device. Testing and labeling 

recommendations are also discussed in the guidance document and also 

help manufacturers address the risk to health. Following the effective 

date of this final classification rule, any firm submitting a 510(k) 

premarket notification for a fully automated short-term incubation 

cycle antimicrobial susceptibility device will need to address the 

issues covered in the special control guidance. However, the firm need 

only show that its device meets the recommendations of the guidance or 

in some other way provides equivalent assurances of safety and 

effectiveness.

    Accordingly, as required by Sec.  860.134(b)(6) and (b)(7) of the 

regulations, FDA is announcing the reclassification of the fully 

automated short-term incubation cycle antimicrobial susceptibility 

device from class III into class II. FDA is codifying the 

reclassification and the special control guidance by adding new Sec.  

866.1645. For the convenience of the reader, FDA is also adding a new 

Sec.  866.1(e) to inform the reader where to find guidance documents 

referenced in 21 CFR part 866.





III. Environmental Impact





    The agency has determined under 21 CFR 25.34(b) that this 

reclassification 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 notice under Executive Order 

12866 and 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 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. Reclassification of the device from class III to 

class II will relieve all manufacturers of the device of the cost of 

complying with the premarket approval requirements in section 515 of 

the act. Because reclassification will reduce regulatory costs with 

respect to this device, it will impose no significant economic impact 

on any small entities, and it may permit small potential competitors to 

enter the marketplace by lowering their costs. The agency therefore 

certifies that this rule will not have a significant economic impact on 

a substantial number of small entities. In addition, this rule will not 

impose costs of $110 million or more on either the private sector or 

State, local, and tribal governments in the aggregate, and therefore a 

summary statement or analysis pursuant to section 202(a) of the 

Unfunded Mandates Reform Act of 1995 is not required.





V. Federalism





    FDA has analyzed this final rule in accordance with the principles 

set forth





[[Page 5827]]





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.





VI. Paperwork Reduction Act of 1995





    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.





List of Subjects in 21 CFR Part 866





    Biologics, Laboratories, 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 866 is amended as follows:





PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES





    1. The authority citation for 21 CFR part 866 continues to read as 

follows:





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

    2. Section 866.1 is amended by adding paragraph (e) to read as 

follows:









Sec.  866.1  Scope.





* * * * *

    (e) Guidance documents referenced in this part are available on the 

Internet at http:www.fda.gov/cdrh.guidance.html.

    3. Section 866.1645 is added to subpart B to read as follows:









Sec.  866.1645  Fully automated short-term incubation cycle 

antimicrobial susceptibility system.





    (a) Identification. A fully automated short-term incubation cycle 

antimicrobial susceptibility system is a device that incorporates 

concentrations of antimicrobial agents into a system for the purpose of 

determining in vitro susceptibility of bacterial pathogens isolated 

from clinical specimens. Test results obtained from short-term (less 

than 16 hours) incubation are used to determine the antimicrobial agent 

of choice to treat bacterial diseases.

    (b) Classification. Class II (special controls). The special 

control for this device is FDA's guidance document entitled ``Class II 

Special Controls Guidance Document: Antimicrobial Susceptibility Test 

(AST) Systems; Guidance for Industry and FDA.''





    Dated: January 9, 2003.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

[FR Doc. 03-2656 Filed 2-4-03; 8:45 am]



BILLING CODE 4160-01-S