[Federal Register Volume 82, Number 218 (Tuesday, November 14, 2017)]
[Rules and Regulations]
[Pages 52649-52651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24586]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2017-N-6289]


Medical Devices; Gastroenterology-Urology Devices; Classification 
of the Prostatic Artery Embolization Device

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 prostatic artery embolization device 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 prostatic artery embolization device'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 November 14, 2017. The classification 
was applicable on June 21, 2017.

FOR FURTHER INFORMATION CONTACT: Benjamin Fisher, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. G108, Silver Spring, MD 20993-0002, 301-
796-0245, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the prostatic artery embolization 
device 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 to a predicate device that does not require 
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new 
device is substantially equivalent to a predicate by means of the 
procedures

[[Page 52650]]

for premarket notification under section 510(k) of the FD&C Act and 
part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    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 (21 U.S.C. 360c(f)(2)). 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 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 pre-market approval 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.

II. De Novo Classification

    On August 5, 2016, BioSphere Medical, S.A., submitted a request for 
De Novo classification of the Embosphere[supreg] Microspheres. FDA 
reviewed the request 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 generals 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 the 
general controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on June 21, 2017, FDA issued an order to the requester 
classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 876.5550. We have named 
the generic type of device prostatic artery embolization device, and it 
is identified as an intravascular implant intended to occlude the 
prostatic arteries to prevent blood flow to the targeted area of the 
prostate, resulting in a reduction of lower urinary tract symptoms 
related to benign prostatic hyperplasia. This does not include 
cyanoacrylates and other embolic agents which act by in situ 
polymerization or precipitation, or embolization devices used in 
neurovascular applications (see 21 CFR 882.5950).
    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--Prostatic Artery Embolization Device Risks and Mitigation
                                Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction................  Biocompatibility evaluation.
Infection..............................  Sterilization validation, Shelf-
                                          life validation, Non-clinical
                                          performance testing, and
                                          Labeling.
Non-target ischemia....................  Clinical data, Non-clinical
                                          performance testing, and
                                          Labeling.
Urinary retention......................  Labeling.
Post-prostatic artery embolization       Labeling.
 syndrome (nausea, vomiting, regional
 pain, non-infectious fever, minor
 hematuria, or hematochezia).
------------------------------------------------------------------------

    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).

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 part 21 CFR part 
814, subparts A through E, regarding premarket approval, have been 
approved under OMB control number 0910-0231; the collections of

[[Page 52651]]

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 876

    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 
876 is amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for part 876 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  876.5550 to subpart F to read as follows:


Sec.  876.5550   Prostatic artery embolization device.

    (a) Identification. A prostatic artery embolization device is an 
intravascular implant intended to occlude the prostatic arteries to 
prevent blood flow to the targeted area of the prostate, resulting in a 
reduction of lower urinary tract symptoms related to benign prostatic 
hyperplasia. This does not include cyanoacrylates and other embolic 
agents which act by in situ polymerization or precipitation, or 
embolization devices used in neurovascular applications (see 21 CFR 
882.5950).
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The device must be demonstrated to be biocompatible.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Evaluation of suitability for injection through catheters 
intended for use in embolization; and
    (ii) Evaluation of the size distribution of the device.
    (3) Performance data must support the sterility and pyrogenicity of 
the device.
    (4) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (5) Clinical data must evaluate post-embolization damage due to 
non-target embolization under anticipated use conditions.
    (6) The labeling must include:
    (i) Specific instructions on safe device preparation and use;
    (ii) The device shelf life;
    (iii) Data regarding urinary retention; and
    (iv) Data regarding post-prostatic artery embolization syndrome.

    Dated: November 7, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017-24586 Filed 11-13-17; 8:45 am]
 BILLING CODE 4164-01-P