[Federal Register: July 3, 2007 (Volume 72, Number 127)]
[Notices]
[Page 36468-36470]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jy07-72]
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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