[Federal Register Volume 83, Number 4 (Friday, January 5, 2018)]
[Rules and Regulations]
[Pages 600-602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00051]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 892
[Docket No. FDA-2017-N-6539]
Medical Devices; Radiology Devices; Classification of the
Absorbable Perirectal Spacer
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the absorbable perirectal spacer into class II (special controls). The
special controls that apply to the device type are identified in this
order and will be part of the codified language for the absorbable
perirectal spacer's classification. We are taking this action because
we have determined that classifying the device into class II (special
controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices, in part by reducing
regulatory burdens.
DATES: This order is effective January 5, 2018. The classification was
applicable on April 1, 2015.
FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-796-5866,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the absorbable perirectal spacer
as class II (special controls), which we have determined will provide a
reasonable assurance of safety and effectiveness. In addition, we
believe this action will enhance patients' access to beneficial
innovation, in part by reducing regulatory burdens by placing the
device into a lower device class than the automatic class III
assignment.
The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA shall
classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the less-burdensome 510(k)
process, when necessary, to market their device.
[[Page 601]]
II. De Novo Classification
On October 1, 2014, Augmenix, Inc. submitted a request for De Novo
classification of the SpaceOAR System. FDA reviewed the request in
order to classify the device under the criteria for classification set
forth in section 513(a)(1) of the FD&C Act.
We classify 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 that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to general
controls, will provide reasonable assurance of the safety and
effectiveness of the device.
Therefore, on April 1, 2015, 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 892.5725. We have named
the generic type of device absorbable perirectal spacer, and it is
identified as a device composed of biodegradable material that
temporarily positions the anterior rectal wall away from the prostate
during radiotherapy for prostate cancer with the intent to reduce the
radiation dose delivered to the anterior rectum. The absorbable spacer
maintains space for the entire course of prostate radiotherapy
treatment and is completely absorbed by the patient's body over time.
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.
Table 1--Absorbable Perirectal Spacer Risks and Mitigation Measures
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Mitigation measures/21 CFR
Identified risks section
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Device functional failure or the device Special Controls (1)(i) (21 CFR
is unable to maintain space stability 892.5725(b)(1)(i)), (1)(ii)
during the course of radiation therapy. (21 CFR 892.5725(b)(1)(ii)),
(1)(iv) (21 CFR
892.5725(b)(1)(iv)), and
(1)(vi) (21 CFR
892.5725(b)(1)(vi)).
Prolonged or delayed procedure......... Special Controls (1)(iii) (21
CFR 892.5725(b)(1)(iii)),
(1)(iv) (21 CFR
892.5725(b)(1)(iv)), (2) (21
CFR 892.5725(b)(2)), and (3)
(21 CFR 892.5725(b)(3)).
Needle penetration and/or spacer Special Controls (1)(iv) (21
material injection into bloodstream, CFR 892.5725(b)(1)(iv)), (2)
bladder, prostate, rectal wall, (21 CFR 892.5725(b)(2)), and
rectum, or urethra. (3) (21 CFR 892.5725(b)(3)).
Incomplete absorption.................. Special Controls (1)(iii) (21
CFR 892.5725(b)(1)(iii)),
(1)(iv) (21 CFR
892.5725(b)(1)(iv)), and
(1)(vii) (21 CFR
892.5725(b)(1)(vii)).
Infection or local tissue inflammatory Special Controls (1)(iv) (21
reactions. CFR 892.5725(b)(1)(iv)),
(1)(v) (21 CFR
892.5725(b)(1)(v)), (1)(vi)
(21 CFR 892.5725(b)(1)(vi)),
(1)(vii) (21 CFR
892.5725(b)(1)(vii)), and (3)
(21 CFR 892.5725(b)(3)).
Pain or discomfort associated with Special Controls (1)(iv) (21
spacer. CFR 892.5725(b)(1)(iv)) and
(3) (21 CFR 892.5725(b)(3)).
Urine retention, bleeding, rectal Special Controls (1)(iii) (21
mucosal damage, ulcers, necrosis, CFR 892.5725(b)(1)(iii)),
constipation, or rectal urgency. (1)(iv) (21 CFR
892.5725(b)(1)(iv)), (1)(vii)
(21 CFR 892.5725(b)(1)(vii)),
(2) (21 CFR 892.5725(b)(2)),
and (3) (21 CFR
892.5725(b)(3)).
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FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. This device is subject to premarket
notification requirements under section 510(k) of the FD&C Act.
III. 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.
IV. Paperwork Reduction Act of 1995
This final 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
the guidance document ``De Novo Classification Process (Evaluation of
Automatic Class III Designation)'' have been approved under OMB control
number 0910-0844; the collections of information in 21 CFR part 814,
subparts A through E, regarding premarket approval, have been approved
under OMB control number 0910-0231; the collections of information in
part 807, subpart E, regarding premarket notification submissions, have
been approved under OMB control number 0910-0120; the collections of
information in part 820 have been approved under OMB control number
0910-0073; 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 892
Medical devices, Radiation protection, X-rays.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
892 is amended as follows:
PART 892--RADIOLOGY DEVICES
0
1. The authority citation for part 892 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 892.5725 to subpart F to read as follows:
Sec. 892.5725 Absorbable perirectal spacer.
(a) Identification. An absorbable perirectal spacer is composed of
biodegradable material that temporarily positions the anterior rectal
wall away from the prostate during radiotherapy for prostate cancer
with the intent to
[[Page 602]]
reduce the radiation dose delivered to the anterior rectum. The
absorbable spacer maintains space for the entire course of prostate
radiotherapy treatment and is completely absorbed by the patient's body
over time.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) The premarket notification submission must include methodology
and results of the following non-clinical and clinical performance
testing. For all clinical investigations used to support premarket
notification submissions for this type of device, line listings of the
study data must be provided.
(i) Performance bench testing must demonstrate appropriate
perirectal space creation and maintenance for the duration of prostate
radiotherapy.
(ii) Performance bench testing must demonstrate that therapeutic
radiation levels do not alter the performance of the device.
(iii) Performance in vivo testing must demonstrate appropriate
deployment of spacer as indicated in the accompanying labeling, and
demonstrate appropriate expansion and absorption characteristics in a
clinically relevant environment.
(iv) Clinical study must demonstrate appropriate spacer stability
and lack of migration for the entire course of radiotherapy, complete
absorption, and lack of long term toxicity.
(v) Sterility testing must demonstrate the sterility of the device
and the effects of the sterilization process on the physical
characteristics of the spacer.
(vi) Shelf-life testing must demonstrate the stability of the
physical characteristics of the spacer throughout the shelf-life as
indicated in the accompanying labeling.
(vii) The device must be demonstrated to be biocompatible.
(2) The risk management activities performed as part of the
manufacturer's Sec. 820.30 design controls must document an
appropriate end user initial training program which will be offered as
part of efforts to mitigate the risk of failure to correctly operate
the device, including, but not limited to, documentation of an
appropriate end user initial training program on the proper spacer
deployment technique.
(3) The device labeling must include the following:
(i) A detailed summary of reported or observed complications
related to the use of the device;
(ii) Appropriate warnings;
(iii) Detailed instructions for system preparations and detailed
implant procedure instructions; and
(iv) An expiration date that is supported by performance data as
specified in paragraph (b)(1)(vi) of this section.
Dated: January 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00051 Filed 1-4-18; 8:45 am]
BILLING CODE 4164-01-P