[Federal Register Volume 72, Number 127 (Tuesday, July 3, 2007)]
[Notices]
[Pages 36468-36470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-12883]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005P-0207]


Medical Devices; Cardiovascular Devices; Denial of Request for 
Change in Classification of Impedance Plethysmograph

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; denial of petition.

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SUMMARY:  The Food and Drug Administration (FDA) is denying the 
petition submitted by Life Measurements Inc., to reclassify the SONAMET 
Body Composition Analyzers (BOD POD and PEA POD) from class II to class 
I. The agency is denying the petition because Life Measurements Inc., 
failed to provide sufficient new information to establish that general 
controls would provide reasonable assurance of the safety and 
effectiveness of the devices. This notice also summarizes the basis for 
the agency's decision.

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, 240-276-
4021.

SUPPLEMENTARY INFORMATION:

I. Classification and Reclassification of Devices Under the 1976 
Amendments

    The Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 301 et 
seq.), as amended by the 1976 amendments (Public Law 94-295), the Safe 
Medical Devices Act of 1990 (SMDA) (Public Law 101-629), and the Food 
and Drug Administration Modernization Act of 1997 (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 under the 1976 amendments were class I (general controls), 
class II (performance standards), and class III (premarket approval).
    Under section 513 of the act, devices that were in commercial 
distribution before May 28, 1976 (the date of enactment of the 
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 type; and (3) published a final regulation 
classifying the device type. 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: (1) The device type is 
reclassified into class I or II; (2) FDA issues an order classifying 
the device into class I or II in accordance with section 513(f)(2) of 
the act; 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 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, subpart E, of the regulations.
    A preamendments device that has been classified into class III may 
be marketed, by means of premarket notification procedures, without 
submission of a Premarket 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 classified preamendments devices is governed by 
section 513(e) of the act. This section of the act provides that FDA 
may, by rulemaking, reclassify a device (in a proceeding that parallels 
the initial classification proceeding) based on ``new information.'' 
The reclassification can be initiated by FDA or by the petition of an 
interested person. The term ``new information,'' as used in sections 
513(e) and 515(b)(2)(A)(iv) of the act, includes information developed 
as a result of a reevaluation of the data before the agency when the 
device was originally classified, as well as information not presented, 
not available, or not developed at that time. (See, e.g., Holland 
Rantos v. United States Department of Health, Education, and Welfare, 
587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 
(6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the agency is an 
appropriate basis for subsequent regulatory action where the 
reevaluation is made in light of newly available regulatory authority 
(see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 
F.Supp. 382, 389-91 (D.D.C. 1991)), or in light of changes in ``medical 
science.'' (See Upjohn v. Finch, supra, 422 F.2d at 951.) Regardless of 
whether data before the agency are past or new data, the ``new 
information'' upon which reclassification under section 513(e) of the 
act is based must consist of ``valid scientific evidence,'' as defined 
in section 513(a)(3) of the act and Sec.  560.7(c)(2) (21 CFR 
860.7(c)(2)). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 
(D.C. Cir. 1985); Contact Lens Assoc. v. FDA, 766 F.2d 592 (D.C. Cir.), 
cert. denied, 474 U.S. 1062 (1985).) In addition, Sec.  860.123(a)(6) 
(21 CFR 860.123(a)(6)) provides that a reclassification petition must 
include a ``full statement of the reasons, together with supporting 
data satisfying the requirements of Sec.  860.7, why the device should 
not be classified into its present

[[Page 36469]]

classification and how the proposed classification will provide 
reasonable assurance of the safety and effectiveness of the device '' 
(Sec.  860.123(a)(6)). The ``supporting data satisfying the 
requirements of Sec.  860.7'' referred to is ``valid scientific 
evidence.''
    For the purpose of reclassification, the valid scientific evidence 
upon which the agency relies must be publicly available. Publicly 
available information excludes trade secret and/or confidential 
commercial information, e.g., the contents of a pending PMA. (See 
section 520(c) of the act (21 U.S.C. 360j(c).)

II. Reclassification Under the SMDA

    The SMDA further amended the act to change the definition of a 
class II device. Under the SMDA, class II devices are those devices 
which cannot be classified into class I because general controls by 
themselves are not sufficient to provide reasonable assurance of 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 guidelines, recommendations, and other 
appropriate actions the agency deems necessary (section 513(a)(1)(B) of 
the act). Thus, the definition of a class II device was changed from 
``performance standards'' to ``special controls.'' In order for a 
device to be reclassified from class II into class I, the agency must 
determine that special controls are not necessary to provide reasonable 
assurance of its safety and effectiveness.

III. Background

    In the Federal Register of February 5, 1980 (45 FR 7930), FDA 
issued a final rule classifying the Impedance Plethysmograph into class 
II (Sec.  870.2770 (21 CFR 870.2770)). The preamble to the proposal to 
classify the device included the recommendation of the Cardiovascular 
Device Classification Panel (the Panel). The Panel's recommendation, 
among other things, identified the following risks to health associated 
with the use of the device: (1) Cardiac arrhythmias or electrical 
shock--Excessive electrical leakage current can disturb the normal 
electrophysiology of the heart, leading to the onset of cardiac 
arrhythmias and (2) Misdiagnosis--If the zero or calibration of the 
device is inaccurate or unstable, or if frequency response of the 
device is improper, the device can generate inaccurate diagnostic data. 
If inaccurate diagnostic data are used in managing the patient, the 
physician may prescribe a course of treatment that places the patient 
at risk unnecessarily.
    On May 25, 2005, FDA received a petition requesting that FDA 
reclassify SONAMET Body Composition Analyzers (BOD POD and PEA POD) 
from class II to class I (Ref. 1). Under Sec.  860.120(b) (21 CFR 
860.120(b)) the reclassification of any device within a generic type of 
devices causes the reclassification of all substantially equivalent 
devices within that generic type of device.
    The May 25, 2005, petition also requested that the SONAMET Body 
Composition Analyzers (BOD POD and PEA POD) be given their own product 
code because their devices are based on air displacement 
plethysmography technology, not impedance plethysmograph technology.

IV. Device Description

    The SONAMET Body Composition Analyzers (BOD POD and PEA POD) are 
classified within the generic type of device impedance plethysmograph 
(Sec.  870.2770) and given the product code MNW. Both SONAMET Body 
Composition Analyzers were found substantially equivalent to class II 
devices under Sec.  870.2770.

V. FDA's Decision

    After reviewing the reclassification petition, FDA has found that 
the petition does not contain sufficient valid scientific evidence to 
support a determination that general controls would provide reasonable 
assurance of the devices' safety and effectiveness for their intended 
uses. Therefore, FDA is denying the reclassification request.
    FDA did determine that both SONAMET Body Composition Analyzers are 
substantially equivalent to other legally marketed body composition 
analyzers classified under Sec.  870.2770, product code MNW, the 
product code for body composition analysis devices. However, due to 
variations in the technology of impedance plethysmographs and 
displacement plethysmographs, FDA has given displacement 
plethysmographs for body composition their own product code under Sec.  
870.2770. FDA is adding a new product code, OAC, to Sec.  870.2770 and 
updating the product code for the SONAMET Body Composition Analyzers 
(BOD POD and PEA POD) under Sec.  870.2770. This new product code will 
be used to classify any plethysmograph device using air displacement 
for body composition analysis that is determined to be substantially 
equivalent.

VI. Reasons for the Denial

    FDA has determined that Life Measurement Inc., has not presented 
new scientific information sufficient to support the requested change 
in classification (class II to class I) of their devices. According to 
Sec.  860.120(b), the reclassification of any device within a generic 
type of device causes the reclassification of all substantially 
equivalent devices within that generic type. Accordingly, a petition 
for the reclassification of a specific device will be considered a 
petition for reclassification of all substantially equivalent devices 
within the same generic type.
    Life Measurement Inc., has (1) not provided sufficient evidence to 
reclassify their own devices and has (2) not provided the required 
elements of a reclassification petition to down-classify any or all 
other body composition analyzers of different technology under Sec.  
870.2770.
    The petitioner's accompanying data refers only to one of Life 
Measurement Inc.'s two devices proposed for reclassification, the BOD 
POD. No new information on the PEA POD was provided. The PEA POD, which 
is intended for use in newborns and infants, is the more critical of 
the two devices. While the patient population being tested with the BOD 
POD can terminate usage of the device during measurement, the patient 
population using the PEA POD (infants) is helpless to intervene in any 
aspect of the device operation if safety is suddenly compromised.
    All the evidence presented by the petitioner is anecdotal and not 
sufficient to support the conclusion that general controls would 
provide reasonable assurance of the safety and effectiveness of this 
type device, including the Life Measurement Inc., devices. No published 
studies have been provided specifically targeting safety regarding 
devices of this type, including the Life Measurement Inc., devices, to 
support the petition. Additionally, the petitioner has not provided any 
information about adverse events or time of use for either of these 
devices.
    However, Life Measurement Inc.'s differing technology for body 
composition is a legitimate basis for consideration of a new product 
code. FDA agrees that variations in the technology of impedance 
plethysmographs and air displacement plethysmographs for body 
composition analysis warrant FDA's assigning air displacement 
plethysmographs for body composition analysis (e.g., BOD POD) their own 
product code under

[[Page 36470]]

Sec.  870.2770. FDA has added a new product code, OAC, to Sec.  
870.2770 and includes the SONAMET Body Composition Analyzers (BOD POD 
and PEA POD) under it.
    FDA believes that the petition lacks sufficient valid scientific 
evidence to allow FDA to determine that general controls would provide 
reasonable assurance of the safety and effectiveness of the impedance 
plethysmograph for its intended use. Therefore, the impedance 
plethysmograph shall be retained in class II.

VII. References

    The following reference has been placed on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Petition from Life Measurement Inc., for the reclassification 
of the SONAMET Body Composition Analyzers (BOD POD and PEA POD) 
devices, dated March 21, 2005.

    Dated: June 25, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-12883 Filed 7-3-07; 8:45 am]
BILLING CODE 4160-01-S