
[Federal Register: April 9, 2009 (Volume 74, Number 67)]
[Notices]               
[Page 16214-16217]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ap09-70]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-M-0101]

 
Medical Devices; Order for Certain Class III Devices; Submission 
of Safety and Effectiveness Information

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is issuing an order 
requiring manufacturers of remaining preamendments class III devices 
for which regulations requiring submission of premarket approval 
applications (PMAs) have not been issued to submit to FDA a summary of,

[[Page 16215]]

and a citation to, any information known or otherwise available to them 
respecting such devices, including adverse safety or effectiveness 
information concerning the devices which has not been submitted under 
the Federal Food, Drug, and Cosmetic Act (the act). FDA is requiring 
the submission of this information in order to determine, for each 
device, whether the classification of the device should be revised to 
require the submission of a PMA or a notice of completion of a Product 
Development Protocol (PDP), or whether the device should be 
reclassified into class I or II.

DATES: Summaries and citations must be submitted by August 7, 2009.

ADDRESSES:  Submit paper copies of summaries and citations to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
copies of summaries and citations to http://www.regulations.gov. 
Identify summaries and citations with the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Sarah K. Morabito, Center for Devices 
and Radiological Health (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-3975.

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    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 (SMDA) (Public Law 101-629), the Food and Drug 
Administration Modernization Act of 1997 (Public Law 105-115), the 
Medical Device User Fee and Modernization Act of 2002 (Public Law 107-
250), the Medical Devices Technical Corrections Act (Public Law 108-
214), and the Food and Drug Administration Amendments Act of 2007 
(Public Law 110-85), establishes a comprehensive system for the 
regulation of medical devices intended for human use. Section 513 of 
the act (21 U.S.C. 360c) requires the classification of medical devices 
into one of three regulatory classes: Class I (general controls), class 
II (special controls), or class III (premarket approval). Generally, 
devices that were on the market before May 28, 1976, the date of 
enactment of the 1976 amendments, and devices marketed on or after that 
date that are substantially equivalent to such devices, have been 
classified by FDA. This order refers to both the class III devices that 
were on the market before May 28, 1976, and the devices found to be 
substantially equivalent to them that were marketed on or after that 
date, as ``preamendments devices.''
    Section 515(b)(1) of the act (21 U.S.C. 360e(b)(1)) establishes the 
requirement that a preamendments device that FDA has classified into 
class III is subject to premarket approval. However, submission of a 
PMA (or a notice of completion of a PDP) is not required until 90 days 
after FDA promulgates a final rule requiring premarket approval for the 
device, or 30 months after final classification of the device, 
whichever is later. See section 501(f)(2)(B) of the act (21 U.S.C. 
351(f)(2)(B)). The device may, however, be distributed only for 
investigational use if the manufacturer, importer, or other sponsor of 
the device complies with the investigational device exemption (IDE) 
requirements.
    The SMDA changed the definition of class II devices from those for 
which a performance standard is necessary to provide reasonable 
assurance of safety and effectiveness to those for which there is 
sufficient information to establish special controls to provide such 
assurance. Special controls include performance standards, postmarket 
surveillance, patient registries, guidelines (including guidelines for 
the submission of clinical data in premarket notification submissions 
in accordance with section 510(k) of the act (21 U.S.C. 360(k))), 
recommendations, and other appropriate actions the agency deems 
necessary to provide such assurance. Thus, the SMDA modified the 
definition of class II devices to permit reliance on special controls, 
rather than performance standards alone, to provide reasonable 
assurance of safety and effectiveness.
    The SMDA also added section 515(i) (21 U.S.C. 360e(i)) to the act. 
This section requires FDA to order manufacturers of preamendments class 
III devices for which no final regulation has been issued requiring the 
submission of PMAs to submit to the agency a summary of, and a citation 
to, any information known or otherwise available to them respecting 
such devices, including adverse safety and effectiveness information 
that has not been submitted under section 519 of the act (21 U.S.C. 
360i). Section 519 of the act requires manufacturers, importers, and 
distributors to maintain records and to report information that 
reasonably suggests that one of its marketed devices may have caused or 
contributed to a death or serious injury or that a malfunction of the 
device is likely to cause death or serious injury on recurrence. 
Section 515(i) of the act also directs FDA to either revise the 
classification of the device into class I or class II or require the 
device to remain in class III; and for devices remaining in class III, 
to establish a schedule for the promulgation of a rule requiring the 
submission of PMAs for the device.
    In the Federal Register of May 6, 1994 (59 FR 23731), FDA announced 
the availability of a notice setting forth its strategy for addressing 
the remaining class III preamendments devices. Of the approximately 149 
preamendments devices FDA initially classified or proposed to classify 
into class III (48 FR 40272, September 6, 1983), FDA has either 
reclassified into class I or II, or issued regulations requiring the 
submission of PMAs for, all but 27 devices. Of the 27 devices, 25 are 
the subject of this notice. The two remaining devices, Herpes simplex 
virus serological assays (21 CFR 866.3305) and Topical oxygen chamber 
for extremities (21 CFR 878.5650), will be addressed in separate 
orders.

II. Statutory Authority and Enforcement

    In addition to the provisions of section 515(i) of the act 
described in section I of this document, this order is issued under 
section 519 of the act, as implemented by Sec.  860.7(g)(2) (21 CFR 
860.7(g)(2)). Section 860.7(g)(2) authorizes FDA to require reports or 
other information bearing on the classification of a device. Section 
519 of the act also requires the reporting of any death or serious 
injury caused by a device or by its malfunction.
    Failure to comply with this order results in the device being 
misbranded under section 502(t) of the act (21 U.S.C. 352(t)) and is a 
prohibited act under sections 301(a) and (q) of the act (21 U.S.C. 
331(a) and (q)). The agency will use its enforcement powers to deter 
noncompliance. Violations of section 301 of the act may be subject to 
seizure or injunction under sections 302(a) and 304(a) of the act (21 
U.S.C. 332(a) and 334(a)). In addition, violations under section 301 of 
the act may be subject to civil penalties under section 303(f) of the 
act (21 U.S.C. 333(f)) and criminal prosecution under section 303(a) of 
the act (21 U.S.C. 333(a)).

III. Order

    The agency is hereby issuing this order under sections 515(i) and 
519 of the act and Sec.  860.7(g)(1) of the regulations. Under the 
order, the required information must be submitted by the date set forth 
in this document (see DATES) so that FDA may begin the process 
established by section 515(i) of

[[Page 16216]]

the act to either reclassify these devices into class I or II or 
initiate rulemaking to require submission of PMAs or PDPs for them. FDA 
does not anticipate extending the time for submitting the required 
information.
    For the following 25 devices, the required information must be 
submitted by August 7, 2009.
    1. 21 CFR 868.5610 Membrane lung for long-term pulmonary support.
    2. 21 CFR 870.3535 Intra-aortic balloon and control system.
    3. 21 CFR 870.3545 Ventricular bypass (assist) device.
    4. 21 CFR 870.3600 External pacemaker pulse generator.
    5. 21 CFR 870.3610 Implantable pacemaker pulse generator.
    6. 21 CFR 870.3680(b) Cardiovascular permanent pacemaker electrode.
    7. 21 CFR 870.3700 Pacemaker programmers.
    8. 21 CFR 870.3710 Pacemaker repair or replacement material.
    9. 21 CFR 870.4360 Nonroller-type cardiopulmonary bypass blood 
pump.
    10. 21 CFR 870.5200 External cardiac compressor.
    11. 21 CFR 870.5225 External counter-pulsating device.
    12. 21 CFR 870.5310 Automated external defibrillator.
    13. 21 CFR 872.3640(b)(2) Endosseous dental implant (blade form).
    14. 21 CFR 872.3960 Mandibular condyle prosthesis (temporary 
implant).
    15. 21 CFR 876.5540(b)(1) Implanted blood access device.
    16. 21 CFR 876.5870 Sorbent hemoperfusion system.
    17. 21 CFR 882.5800 Cranial electrotherapy stimulator.
    18. 21 CFR 882.5940 Electroconvulsive therapy device.
    19. 21 CFR 884.5330 Female condom.
    20. 21 CFR 888.3070(b)(2) Pedicle screw spinal system (certain 
uses).
    21. 21 CFR 888.3320 Hip joint metal/metal semi-constrained, with a 
cemented acetabular component, prosthesis.
    22. 21 CFR 888.3330 Hip joint metal/metal semi-constrained, with an 
uncemented acetabular component, prosthesis.
    23. 21 CFR 890.5290(b) Shortwave diathermy (certain uses).
    24. 21 CFR 890.5525(b) Iontophoresis device (certain uses).
    25. 892.1990 Transilluminator for breast evaluation.

Required Contents of Submissions

    By the date listed in the DATES section of this document, all 
manufacturers currently marketing the preamendments class III devices 
subject to this order shall provide a summary of, and citation to, any 
information known or otherwise available to them respecting the 
devices, including adverse safety and effectiveness data that has not 
been submitted under section 519 of the act. FDA suggests that it may 
be in the best interest of submitters to summarize the information 
submitted under section 519 of the act to facilitate FDA's 
decisionmaking.
    The information should be submitted in one of the two following 
formats depending on whether the manufacturer is aware of information 
that would support the reclassification of the device into class I 
(general controls) or class II (special controls). Information that 
would support the reclassification of the device must consist of 
adequate, valid scientific evidence showing that general controls 
alone, or general controls along with special controls, will provide a 
reasonable assurance of the safety and effectiveness of the device.
    If a manufacturer is not aware of information that would support 
the reclassification of its device into class I or class II, the 
information should be submitted in the following format:
    1. Indications for use. A general description of the disease or 
condition to be diagnosed, treated, cured, mitigated, or prevented, 
including a description of the patient population for which the device 
is intended.
    2. Device description. An explanation of how the device functions, 
significant physical and performance characteristics of the device, and 
basic scientific concepts that form the basis for the device.
    3. Other device labeling. Other device labeling that includes 
contraindications, warnings and precautions and/or promotional 
materials.
    4. Risks. A summary of all adverse safety and effectiveness 
information and identification of the risks presented by the device as 
well as any mechanisms or procedures which will control the risk.
    5. Alternative practices and procedures. A description of 
alternative practices or procedures for diagnosing, treating, 
preventing, curing, or mitigating the disease or condition for which 
the device is intended.
    6. Summary of preclinical and clinical data. The summary of 
preclinical and clinical data should include the conclusions drawn from 
the studies that support the safety and effectiveness of the device, 
and that address the adverse effects of the device on health. The 
summary should include a brief description of the objective of the 
studies, the experimental design, how the data were collected and 
analyzed, and a brief description of the results of the studies, 
whether positive, negative, or inconclusive. The summary of the 
clinical study should also include a discussion of the subject 
inclusion and exclusion criteria, the study population, reasons for 
patient discontinuations, and results of statistical analyses.
    7. Bibliography. A copy of each key reference, a brief summary of 
the salient features of each key reference, and a brief discussion of 
why the reference is relevant to an evaluation of the safety and 
effectiveness of the device.
    Any manufacturer who is aware of information that would support the 
reclassification of its device into class I or class II may either 
submit information using the format described below or may submit a 
formal reclassification petition, which as described in 21 CFR 
860.123(a)(3) and (a)(4), should include:
    1. Identification. A brief narrative identification of the device. 
This identification should be specific enough to distinguish a 
particular device from a generic type of device. Where appropriate, 
this identification should include a listing of the materials, and the 
component parts, and a description of the intended use of the device.
    2. Risks to health. An identification of the risks to health. This 
section should summarize all adverse safety and effectiveness 
information that has not been submitted under section 519 of the act, 
particularly the most significant information. The mechanisms or 
procedures that will control the risk should be described. A list of 
the general hazards associated with the device and a bibliography with 
copies of the referenced material should be provided.
    3. Recommendation. A statement whether the manufacturer believes 
the device should be reclassified into class I or class II.
    4. Summary of reasons for recommendation. Each manufacturer should 
include a summary of the reasons for requesting reclassification of its 
device and an explanation of why it believes the device meets the 
statutory criteria for reclassification into class I or class II. Each 
manufacturer should also identify the special controls that it believes 
would be sufficient to provide reasonable assurance of the safety and 
effectiveness of its device if it believes the device should be 
reclassified into class II.
    5. Summary of valid scientific evidence on which the recommendation 
is based. Manufacturers are advised that, when considering a formal 
reclassification petition, FDA will rely

[[Page 16217]]

only upon valid scientific evidence to determine whether there is 
reasonable assurance of the safety and effectiveness of the device, if 
regulated by general controls alone (class I) or by general controls 
and special controls (class II). Valid scientific evidence consists of 
evidence from well-controlled investigations, partially controlled 
studies, studies and objective trials without matched controls, well-
documented case histories conducted by qualified experts, and reports 
of significant human experience with a marketed device, from which it 
can fairly and responsibly be concluded by qualified experts that there 
is reasonable assurance of the safety and effectiveness of a device 
under its conditions of use. The evidence required may vary according 
to the characteristics of the device, its conditions of use, the 
existence and adequacy of warnings and other restrictions, and the 
extent of experience with its use. Isolated case reports, random 
experience, reports lacking sufficient details to permit scientific 
evaluation, and unsubstantiated opinions are not regarded as valid 
scientific evidence to show safety or effectiveness (see Sec.  
860.7(c)(2)).
    According to Sec.  860.7(d)(1), there is reasonable assurance that 
a device is safe when it can be determined, based upon valid scientific 
evidence, that the probable benefits to health from use of the device 
for its intended uses and conditions of use, when accompanied by 
adequate directions and warnings against unsafe use, outweigh any 
probable risks. The valid scientific evidence used to determine the 
safety of a device shall adequately demonstrate the absence of 
unreasonable risk of illness or injury associated with the use of the 
device for its intended uses and conditions for use. Moreover, under 
Sec.  860.7(e)(1), there is reasonable assurance that a device is 
effective when it can be determined, based upon valid scientific 
evidence, that in a significant portion of the target population, the 
use of the device for its intended uses and conditions of use, when 
accompanied by adequate directions for use and warnings against unsafe 
use, will provide clinically significant results.

IV. Submission of Required Information

    The summary of, and citation to, any information required by the 
act must be submitted by the dates listed in the DATES section of this 
document to the Division of Dockets Management (see ADDRESSES).

V. Paperwork Reduction Act of 1995

    This order refers to collections of information necessary to comply 
with the requirements found in sections 510(k) of the act (21 U.S.C. 
360(k)) and 21 CFR part 807, subpart E or the requirements of 515(b) of 
the act (21 U.S.C. 360e(b)), 21 CFR part 860, and 21 CFR part 814. 
These collections of information are subject to review by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520). The collections of information in 21 CFR 860.123 
have been approved under OMB control number 0910-0138; the collections 
of information in 21 CFR part 814, have been approved under OMB control 
number 0910-0231; and the collections of information in 21 CFR part 
807, subpart E have been approved under OMB control number 0910-0120.

    Dated: April 2, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-8022 Filed 4-8-09; 8:45 am]

BILLING CODE 4160-01-S
