Medical Devices; Cardiovascular Devices; Classification of the Apical Closure Device, 71370-71371 [2016-25002]
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Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Rules and Regulations
level because of your impairment or
because of the removal of special
conditions that took into account your
impairment and permitted you to work.
*
*
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*
■ 9. Amend § 416.999a by revising
paragraph (a)(4)(i) and (c)(2) to read as
follows:
§ 416.999a Who is eligible for expedited
reinstatement?
(a) * * *
(4) * * *
(i) You are not able or become unable
to do substantial gainful activity
because of your medical condition as
determined under paragraph (c) of this
section.
*
*
*
*
*
(c) * * *
(2) You are not able or become unable
to do substantial gainful activity in the
month you file your request for
reinstatement; and
*
*
*
*
*
[FR Doc. 2016–24873 Filed 10–14–16; 8:45 am]
BILLING CODE 4191–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA–2016–N–2766]
Medical Devices; Cardiovascular
Devices; Classification of the Apical
Closure Device
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA) is classifying the
apical closure device into class II
(special controls). The special controls
that will apply to the device are
identified in this order and will be part
of the codified language for the apical
closure device’s classification. The
Agency is classifying the device into
class II (special controls) in order to
provide a reasonable assurance of safety
and effectiveness of the device.
DATES: This order is effective October
17, 2016. The classification was
applicable on July 27, 2016.
FOR FURTHER INFORMATION CONTACT:
Jennifer Piselli, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave. Bldg. 66, Rm. 1561, Silver Spring,
jstallworth on DSK7TPTVN1PROD with RULES
SUMMARY:
VerDate Sep<11>2014
14:00 Oct 14, 2016
Jkt 241001
MD, 20993–0002, 240–402–6646,
jennifer.piselli@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 513(f)(1) of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C.
360c(f)(1)), devices that were not in
commercial distribution before May 28,
1976 (the date of enactment of the
Medical Device Amendments of 1976),
generally referred to as postamendments
devices, are classified automatically by
statute into class III without any FDA
rulemaking process. These devices
remain in class III and require
premarket approval unless and until the
device is classified or reclassified into
class I or II, or FDA issues an order
finding the device to be substantially
equivalent, in accordance with section
513(i), to a predicate device that does
not require premarket approval. The
Agency determines whether new
devices are substantially equivalent to
predicate devices by means of
premarket notification procedures in
section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and part 807 (21 CFR part
807) of the regulations.
Section 513(f)(2) of the FD&C Act, as
amended by section 607 of the Food and
Drug Administration Safety and
Innovation Act (Pub. L. 112–144),
provides two procedures by which a
person may request FDA to classify a
device under the criteria set forth in
section 513(a)(1). Under the first
procedure, the person submits a
premarket notification under section
510(k) of the FD&C Act for a device that
has not previously been classified and,
within 30 days of receiving an order
classifying the device into class III
under section 513(f)(1) of the FD&C Act,
the person requests a classification
under section 513(f)(2). Under the
second procedure, rather than first
submitting a premarket notification
under section 510(k) of the FD&C Act
and then a request for classification
under the first procedure, the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence and requests a classification
under section 513(f)(2) of the FD&C Act.
If the person submits a request to
classify the device under this second
procedure, FDA may decline to
undertake the classification request if
FDA identifies a legally marketed device
that could provide a reasonable basis for
review of substantial equivalence with
PO 00000
Frm 00046
Fmt 4700
Sfmt 4700
the device or if FDA determines that the
device submitted is not of ‘‘lowmoderate risk’’ or that general controls
would be inadequate to control the risks
and special controls to mitigate the risks
cannot be developed.
In response to a request to classify a
device under either procedure provided
by section 513(f)(2) of the FD&C Act,
FDA shall classify the device by written
order within 120 days. This
classification will be the initial
classification of the device.
On June 25, 2015, Micro
Interventional Devices, Inc. submitted a
request for classification of the
Permaseal Device under section
513(f)(2) of the FD&C Act.
In accordance with section 513(f)(2) of
the FD&C Act, FDA reviewed the
request in order to classify the device
under the criteria for classification set
forth in section 513(a)(1). FDA classifies
devices into class II if general controls
by themselves are insufficient to
provide reasonable assurance of safety
and effectiveness, but there is sufficient
information to establish special controls
to provide reasonable assurance of the
safety and effectiveness of the device for
its intended use. After review of the
information submitted in the request,
FDA determined that the device can be
classified into class II with the
establishment of special controls. FDA
believes these special controls, in
addition to general controls, will
provide reasonable assurance of the
safety and effectiveness of the device.
Therefore, on July 27, 2016, FDA
issued an order to the requestor
classifying the device into class II. FDA
is codifying the classification of the
device by adding 21 CFR 870.4510.
Following the effective date of this
final classification order, any firm
submitting a premarket notification
(510(k)) for an apical closure device will
need to comply with the special
controls named in this final
administrative order.
The device is assigned the generic
name apical closure device, and it is
identified as a prescription device
consisting of a delivery system and
implant component that is used for soft
tissue approximation of cardiac apical
tissue during transcatheter valve
replacement procedures.
FDA has identified the following risks
to health associated specifically with
this type of device and the measures
required to mitigate these risks in table
1:
E:\FR\FM\17OCR1.SGM
17OCR1
Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Rules and Regulations
71371
TABLE 1—APICAL CLOSURE DEVICE RISKS AND MITIGATION MEASURES
Identified risk
Mitigation measure
Infection ....................................................................................................
Adverse Tissue Reaction .........................................................................
Bleeding ....................................................................................................
D At ventricular puncture or anchor deployment sites .......................
Tissue Damage ........................................................................................
D Apical tearing ..................................................................................
D Myocardial tearing (local or diffuse) ...............................................
New Hypokinesia or Akinesis of Apex .....................................................
Thromboemboli and Full Thickness Injury ...............................................
Pericardial Tamponade ............................................................................
FDA believes that special controls, in
combination with the general controls,
address these risks to health and
provide reasonable assurance of the
safety and effectiveness.
Apical closure devices are not safe for
use except under the supervision of a
practitioner licensed by law to direct the
use of the device. As such, the device
is a prescription device and must satisfy
prescription labeling requirements (see
21 CFR 801.109 Prescription devices).
Section 510(m) of the FD&C Act
provides that FDA may exempt a class
II device from the premarket notification
requirements under section 510(k), if
FDA determines that premarket
notification is not necessary to provide
reasonable assurance of the safety and
effectiveness of the device. For this type
of device, FDA has determined that
premarket notification is necessary to
provide reasonable assurance of the
safety and effectiveness of the device.
Therefore, this device type is not
exempt from premarket notification
requirements. Persons who intend to
market this type of device must submit
to FDA a premarket notification, prior to
marketing the device, which contains
information about the apical closure
device they intend to market.
jstallworth on DSK7TPTVN1PROD with RULES
The Agency has determined under 21
CFR 25.34(b) that this action 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.
14:00 Oct 14, 2016
Jkt 241001
III. Paperwork Reduction Act of 1995
This final administrative order
establishes special controls that refer to
previously approved collections of
information found in other FDA
regulations. 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 part 807,
subpart E, regarding premarket
notification submissions have been
approved under OMB control number
0910–0120, and the collections of
information in 21 CFR part 801,
regarding labeling have been approved
under OMB control number 0910–0485.
List of Subjects in 21 CFR Part 870
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 870 is
amended as follows:
PART 870—CARDIOVASCULAR
DEVICES
1. The authority citation for part 870
is revised to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 870.4510 to subpart E to read
as follows:
■
II. Analysis of Environmental Impact
VerDate Sep<11>2014
Sterilization Validation.
Shelf Life Testing.
Labeling.
Biocompatibility Evaluation.
In vivo Performance Testing.
Non-clinical Performance Testing.
In vivo Performance Testing.
Labeling.
Non-clinical Performance Testing.
In vivo Performance Testing.
Labeling.
Training.
In vivo Performance Testing.
Labeling.
In vivo Performance Testing.
Labeling.
Training.
In vivo Performance Testing.
Labeling.
§ 870.4510
Apical closure device.
(a) Identification. An apical closure
device is a prescription device
consisting of a delivery system and
implant component that is used for soft
tissue approximation of cardiac apical
tissue during transcatheter valve
replacement procedures.
PO 00000
Frm 00047
Fmt 4700
Sfmt 9990
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) The patient contacting materials
must be evaluated to be biocompatible.
(2) Performance data must validate
the sterility of the patient-contacting
components of the device.
(3) Performance data must support the
shelf life of the device by demonstrating
continued sterility, package integrity,
and device functionality over the
labeled shelf life.
(4) Non-clinical performance testing
data must demonstrate that the device
performs as intended under anticipated
conditions of use. The following
performance characteristics must be
tested:
(i) Consistent and reliable implant
deployment;
(ii) Assessment of implant pull-out
force; and
(iii) Sheath size compatibility with
implant.
(5) In vivo evaluation of the device
must demonstrate device performance,
including device operation resulting in
closure of the myocardial wound.
(6) Labeling must include the
following:
(i) Detailed information explaining
how the device operates;
(ii) Sheath size that device can
accommodate;
(iii) Identification of the minimum
myocardial wall thickness to ensure
optimal device function; and
(iv) A shelf life.
Dated: October 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–25002 Filed 10–14–16; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\17OCR1.SGM
17OCR1
Agencies
[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)]
[Rules and Regulations]
[Pages 71370-71371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25002]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA-2016-N-2766]
Medical Devices; Cardiovascular Devices; Classification of the
Apical Closure Device
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is classifying the
apical closure device into class II (special controls). The special
controls that will apply to the device are identified in this order and
will be part of the codified language for the apical closure device's
classification. The Agency is classifying the device into class II
(special controls) in order to provide a reasonable assurance of safety
and effectiveness of the device.
DATES: This order is effective October 17, 2016. The classification was
applicable on July 27, 2016.
FOR FURTHER INFORMATION CONTACT: Jennifer Piselli, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 66, Rm. 1561, Silver Spring, MD, 20993-0002, 240-
402-6646, jennifer.piselli@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval unless and until the device
is classified or reclassified into class I or II, or FDA issues an
order finding the device to be substantially equivalent, in accordance
with section 513(i), to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1).
Under the first procedure, the person submits a premarket notification
under section 510(k) of the FD&C Act for a device that has not
previously been classified and, within 30 days of receiving an order
classifying the device into class III under section 513(f)(1) of the
FD&C Act, the person requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a premarket
notification under section 510(k) of the FD&C Act and then a request
for classification under the first procedure, the person determines
that there is no legally marketed device upon which to base a
determination of substantial equivalence and requests a classification
under section 513(f)(2) of the FD&C Act. If the person submits a
request to classify the device under this second procedure, FDA may
decline to undertake the classification request if FDA identifies a
legally marketed device that could provide a reasonable basis for
review of substantial equivalence with the device or if FDA determines
that the device submitted is not of ``low-moderate risk'' or that
general controls would be inadequate to control the risks and special
controls to mitigate the risks cannot be developed.
In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA shall
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
On June 25, 2015, Micro Interventional Devices, Inc. submitted a
request for classification of the Permaseal Device under section
513(f)(2) of the FD&C Act.
In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1). FDA classifies devices
into class II if general controls by themselves are insufficient to
provide reasonable assurance of safety and effectiveness, but there is
sufficient information to establish special controls to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the
request, FDA determined that the device can be classified into class II
with the establishment of special controls. FDA believes these special
controls, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of the device.
Therefore, on July 27, 2016, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 870.4510.
Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for an apical
closure device will need to comply with the special controls named in
this final administrative order.
The device is assigned the generic name apical closure device, and
it is identified as a prescription device consisting of a delivery
system and implant component that is used for soft tissue approximation
of cardiac apical tissue during transcatheter valve replacement
procedures.
FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1:
[[Page 71371]]
Table 1--Apical Closure Device Risks and Mitigation Measures
------------------------------------------------------------------------
Identified risk Mitigation measure
------------------------------------------------------------------------
Infection.............................. Sterilization Validation.
Shelf Life Testing.
Labeling.
Adverse Tissue Reaction................ Biocompatibility Evaluation.
In vivo Performance Testing.
Bleeding............................... Non-clinical Performance
Testing.
[ssquf] At ventricular puncture or In vivo Performance Testing.
anchor deployment sites. Labeling.
Tissue Damage.......................... Non-clinical Performance
Testing.
[ssquf] Apical tearing............. In vivo Performance Testing.
[ssquf] Myocardial tearing (local Labeling.
or diffuse). Training.
New Hypokinesia or Akinesis of Apex.... In vivo Performance Testing.
Labeling.
Thromboemboli and Full Thickness Injury In vivo Performance Testing.
Labeling.
Training.
Pericardial Tamponade.................. In vivo Performance Testing.
Labeling.
------------------------------------------------------------------------
FDA believes that special controls, in combination with the general
controls, address these risks to health and provide reasonable
assurance of the safety and effectiveness.
Apical closure devices are not safe for use except under the
supervision of a practitioner licensed by law to direct the use of the
device. As such, the device is a prescription device and must satisfy
prescription labeling requirements (see 21 CFR 801.109 Prescription
devices).
Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k), if FDA determines that premarket notification is not necessary
to provide reasonable assurance of the safety and effectiveness of the
device. For this type of device, FDA has determined that premarket
notification is necessary to provide reasonable assurance of the safety
and effectiveness of the device. Therefore, this device type is not
exempt from premarket notification requirements. Persons who intend to
market this type of device must submit to FDA a premarket notification,
prior to marketing the device, which contains information about the
apical closure device they intend to market.
II. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.34(b) that this action 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.
III. Paperwork Reduction Act of 1995
This final administrative order establishes special controls that
refer to previously approved collections of information found in other
FDA regulations. 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 part 807, subpart E, regarding premarket notification
submissions have been approved under OMB control number 0910-0120, and
the collections of information in 21 CFR part 801, regarding labeling
have been approved under OMB control number 0910-0485.
List of Subjects in 21 CFR Part 870
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
870 is amended as follows:
PART 870--CARDIOVASCULAR DEVICES
0
1. The authority citation for part 870 is revised to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 870.4510 to subpart E to read as follows:
Sec. 870.4510 Apical closure device.
(a) Identification. An apical closure device is a prescription
device consisting of a delivery system and implant component that is
used for soft tissue approximation of cardiac apical tissue during
transcatheter valve replacement procedures.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) The patient contacting materials must be evaluated to be
biocompatible.
(2) Performance data must validate the sterility of the patient-
contacting components of the device.
(3) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the labeled shelf life.
(4) Non-clinical performance testing data must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be tested:
(i) Consistent and reliable implant deployment;
(ii) Assessment of implant pull-out force; and
(iii) Sheath size compatibility with implant.
(5) In vivo evaluation of the device must demonstrate device
performance, including device operation resulting in closure of the
myocardial wound.
(6) Labeling must include the following:
(i) Detailed information explaining how the device operates;
(ii) Sheath size that device can accommodate;
(iii) Identification of the minimum myocardial wall thickness to
ensure optimal device function; and
(iv) A shelf life.
Dated: October 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25002 Filed 10-14-16; 8:45 am]
BILLING CODE 4164-01-P