Medical Devices; Anesthesiology Devices; Neurological Devices; Denial of Request for Change in Classification of Breathing Frequency Monitor and Electroencephalograph, 40130-40131 [E6-11115]
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Federal Register / Vol. 71, No. 135 / Friday, July 14, 2006 / Notices
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to PHENERGAN (promethazine HCl)
tablets, 12.5 mg and 50 mg, may be
approved by the agency as long as they
meet all relevant legal and regulatory
requirements for the approval of
ANDAs.
Dated: June 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–11072 Filed 7–13–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0266]
Medical Devices; Anesthesiology
Devices; Neurological Devices; Denial
of Request for Change in Classification
of Breathing Frequency Monitor and
Electroencephalograph
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; denial of petition.
SUMMARY: The Food and Drug
Administration (FDA) is denying the
petitions submitted by IM Systems to
reclassify the SleepCheck, the ActiTrac,
and PAM–RL devices from class II
(special controls) to class I (general
controls). The agency is denying the
petitions because the petitioner failed to
provide sufficient new information to
establish that general controls would
provide reasonable assurance of the
safety and effectiveness of the devices.
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,
301–594–1190.
SUPPLEMENTARY INFORMATION:
jlentini on PROD1PC65 with NOTICES
I. Classification and Reclassification of
Devices Under the Medical Devices
Amendments of 1976 (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)
VerDate Aug<31>2005
17:44 Jul 13, 2006
Jkt 208001
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 are class I (general
controls), class II (special controls), 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; and (3) published
a final regulation classifying the device.
FDA has classified most preamendment
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. Postamendments devices
remain in class III and require
premarket approval, unless: (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 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 predicate 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.
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 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
section 513(e) 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
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
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
§ 860.7(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, § 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 § 860.7, why the device
should not be classified into its present
classification and how the proposed
classification will provide reasonable
assurance of the safety and effectiveness
of the device.’’ (§ 860.123(a)(6).) The
‘‘supporting data satisfying the
requirements of § 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
SMDA further amended the act to
change the definition of a class II
device. Under the SMDA, class II
devices are those devices that 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
E:\FR\FM\14JYN1.SGM
14JYN1
Federal Register / Vol. 71, No. 135 / Friday, July 14, 2006 / Notices
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 to class I, the agency must
determine that special controls are not
necessary to provide reasonable
assurance of its safety and effectiveness.
jlentini on PROD1PC65 with NOTICES
III. Background
In the Federal Register of July 16,
1982 (47 FR 31130), FDA issued a final
rule classifying the breathing frequency
monitor into class II (§ 868.2375). The
preamble to the proposal to classify the
device included the recommendation of
the Anesthesiology Device Panel. The
Panel identified the following risks to
health associated with the use of the
devices: (1) Failure of the device or
alarm may cause abnormal conditions to
go undiscovered and result in serious
patient injury or death and (2) if the
device does not monitor the patient’s
breathing frequency accurately he/she
may receive incorrect therapy.
In the Federal Register of September
4, 1979 (44 FR 51726), FDA issued a
final rule classifying the
electroencephalograph into class II
(§ 882.1400 (21 CFR 882.1400)). The
preamble to the proposal to classify the
device included the recommendation of
the Neurological Device Panel. The
Panel’s recommendation identified the
following risks to health associated with
use of the device: (1) Misuse of the
device as a result of using untrained
persons may result in improper
diagnosis and treatment; (2)
misdiagnosis of the physiological
symptoms could cause a misdiagnosis
and lead to improper treatment of the
patient’s neurological condition; and (3)
electrical shock could be associated
with current leakage of the device,
making it hazardous because the device
makes a low resistance contact with the
patient.
On August 18, 2004, IM Systems
submitted three petitions requesting
FDA to reclassify the SleepCheck
device, the ActiTrac, and PAM–RL
devices from class II to class I (Ref. 1).
Under 21 CFR 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 of device.
IV. Device Description
The SleepCheck device is classified
within the generic type of device called
the breathing frequency monitor
(§ 868.2375). FDA identifies the
breathing frequency monitor as a device
intended to measure or monitor a
patient’s respiratory rate. The device
VerDate Aug<31>2005
17:44 Jul 13, 2006
Jkt 208001
may provide an audible or visible alarm
when the respiratory rate, averaged over
time, is outside operator settable alarm
limits.
The ActiTrac and PAM–RL devices
are classified within the generic type of
device called the electroencephalograph
(§ 882.1400). FDA identifies the
electroencephalograph as a device used
to measure and record the electrical
activity of the patient’s brain obtained
by placing two or more electrodes on
the head.
V. FDA’s Decision
After reviewing both the
reclassification petitions and the
petitioner’s responses to our subsequent
requests for information, FDA has found
that the petitions do not contain any
valid scientific evidence to support a
conclusion that general controls would
provide reasonable assurance of the
devices’ safety and effectiveness for
their intended uses or that special
controls are not necessary to provide
reasonable assurance of the safety and
effectiveness of the devices. Therefore,
FDA is denying the petitions for
reclassification of these device types.
VI. References
The following references have been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
These references may be seen by
interested persons between 9 a.m. and 4
p.m., Monday through Friday.
1. Petitions from IM Systems for the
reclassification of the SleepCheck device,
PAM–RL device, and the ActiTrac device,
dated August 18, 2004.
Dated: July 5, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E6–11115 Filed 7–13–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
40131
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Method for Expanding Allodepleted
Antigen Specific T Cells
Description of Technology: Available
for licensing and commercial
development are methods of producing
a population of purified nonalloreactive antigen-specific T cells that
recognize an antigen of interest. Thus,
the population of donor T cells can be
used to produce immune response
against the antigen of interest (e.g.,
cytomegalovirus) in a recipient without
producing an immune response to the
recipient. Currently available methods
for isolating and expanding antigenspecific T cells can be inefficient and
produce populations of cells that
include donor-reactive T cells. The
present method enables rapid
production of populations of T cells that
recognize an antigen of interest but are
depleted for alloreactive T cells: A
population of donor T cells is contacted
with a population of irradiated recipient
antigen presenting cells (T–APCs) to
produce a population of alloreactive T
cells. The alleractive T cells are
removed by purification with an
antibody that specifically binds a cell
surface marker (e.g., CD25, CD69, CD38
or CD71). The population of allodepleted donor cells is then contacted
with donor T antigen presenting cells
(T–APCs) expressing an antigen of
interest and produces a population of
donor allo-depleted activated CD4 and
CD8 T cells.
Applications: Immune response to
opportunistic infectious in immunocompromised transplant or graft
recipients.
Market: (1) Cytomegalovirus; (2)
General post-transplant opportunistic
infections.
Inventors: J. Joseph Melenhorst and A.
John Barrett (NHLBI).
Publications:
1. JJ Melenhorst, TH Brummendorf, M
Kirby, PM Lansdorp, AJ Barrett. ‘‘CD8+T
cells in large granular lymphocyte
E:\FR\FM\14JYN1.SGM
14JYN1
]]>Agencies
[Federal Register Volume 71, Number 135 (Friday, July 14, 2006)]
[Notices]
[Pages 40130-40131]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-11115]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0266]
Medical Devices; Anesthesiology Devices; Neurological Devices;
Denial of Request for Change in Classification of Breathing Frequency
Monitor and Electroencephalograph
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; denial of petition.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is denying the
petitions submitted by IM Systems to reclassify the SleepCheck, the
ActiTrac, and PAM-RL devices from class II (special controls) to class
I (general controls). The agency is denying the petitions because the
petitioner failed to provide sufficient new information to establish
that general controls would provide reasonable assurance of the safety
and effectiveness of the devices.
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, 301-594-
1190.
SUPPLEMENTARY INFORMATION:
I. Classification and Reclassification of Devices Under the Medical
Devices Amendments of 1976 (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 are class I (general controls), class
II (special controls), 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; and (3) published a final regulation
classifying the device. FDA has classified most preamendment 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. Postamendments devices remain in
class III and require premarket approval, unless: (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 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
predicate 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.
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 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 section
513(e) 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.
860.7(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
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
SMDA further amended the act to change the definition of a class II
device. Under the SMDA, class II devices are those devices that 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
[[Page 40131]]
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 to 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 July 16, 1982 (47 FR 31130), FDA issued
a final rule classifying the breathing frequency monitor into class II
(Sec. 868.2375). The preamble to the proposal to classify the device
included the recommendation of the Anesthesiology Device Panel. The
Panel identified the following risks to health associated with the use
of the devices: (1) Failure of the device or alarm may cause abnormal
conditions to go undiscovered and result in serious patient injury or
death and (2) if the device does not monitor the patient's breathing
frequency accurately he/she may receive incorrect therapy.
In the Federal Register of September 4, 1979 (44 FR 51726), FDA
issued a final rule classifying the electroencephalograph into class II
(Sec. 882.1400 (21 CFR 882.1400)). The preamble to the proposal to
classify the device included the recommendation of the Neurological
Device Panel. The Panel's recommendation identified the following risks
to health associated with use of the device: (1) Misuse of the device
as a result of using untrained persons may result in improper diagnosis
and treatment; (2) misdiagnosis of the physiological symptoms could
cause a misdiagnosis and lead to improper treatment of the patient's
neurological condition; and (3) electrical shock could be associated
with current leakage of the device, making it hazardous because the
device makes a low resistance contact with the patient.
On August 18, 2004, IM Systems submitted three petitions requesting
FDA to reclassify the SleepCheck device, the ActiTrac, and PAM-RL
devices from class II to class I (Ref. 1). Under 21 CFR 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 of device.
IV. Device Description
The SleepCheck device is classified within the generic type of
device called the breathing frequency monitor (Sec. 868.2375). FDA
identifies the breathing frequency monitor as a device intended to
measure or monitor a patient's respiratory rate. The device may provide
an audible or visible alarm when the respiratory rate, averaged over
time, is outside operator settable alarm limits.
The ActiTrac and PAM-RL devices are classified within the generic
type of device called the electroencephalograph (Sec. 882.1400). FDA
identifies the electroencephalograph as a device used to measure and
record the electrical activity of the patient's brain obtained by
placing two or more electrodes on the head.
V. FDA's Decision
After reviewing both the reclassification petitions and the
petitioner's responses to our subsequent requests for information, FDA
has found that the petitions do not contain any valid scientific
evidence to support a conclusion that general controls would provide
reasonable assurance of the devices' safety and effectiveness for their
intended uses or that special controls are not necessary to provide
reasonable assurance of the safety and effectiveness of the devices.
Therefore, FDA is denying the petitions for reclassification of these
device types.
VI. References
The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. These references may
be seen by interested persons between 9 a.m. and 4 p.m., Monday through
Friday.
1. Petitions from IM Systems for the reclassification of the
SleepCheck device, PAM-RL device, and the ActiTrac device, dated
August 18, 2004.
Dated: July 5, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-11115 Filed 7-13-06; 8:45 am]
BILLING CODE 4160-01-S
