[Federal Register Volume 83, Number 45 (Wednesday, March 7, 2018)]
[Rules and Regulations]
[Pages 9698-9700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04616]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2018-N-0387]


Medical Devices; General and Plastic Surgery Devices; 
Classification of the Extracorporeal Shock Wave Device for Treatment of 
Chronic Wounds

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 extracorporeal shock wave device for treatment of chronic wounds 
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 extracorporeal shock wave device for 
treatment of chronic wounds' 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 March 7, 2018. The classification was 
applicable on December 28, 2017.

FOR FURTHER INFORMATION CONTACT: Mehmet Kosoglu, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1572, Silver Spring, MD 20993-0002, 301-796-6194, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the extracorporeal shock wave 
device for treatment of chronic wounds 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 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. 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 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.

II. De Novo Classification

    On July 25, 2016, Sanuwave, Inc., submitted a request for De Novo 
classification of the dermaPACE 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

[[Page 9699]]

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 December 28, 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 878.4685. We have named 
the generic type of device extracorporeal shock wave device for 
treatment of chronic wounds, and it is identified as a prescription 
device that focuses acoustic shock waves onto the dermal tissue. The 
shock waves are generated inside the device and transferred to the body 
using an acoustic interface.
    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--Extracorporeal Shock Wave Device for Treatment of Chronic
                  Wounds Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Adverse tissue reaction................  Biocompatibility evaluation.
Infection..............................  Reprocessing validation and
                                          Labeling.
Inadequate healing.....................  Labeling.
Device failure/malfunction leading to    Non-clinical performance
 application site injury.                 testing; Electrical safety
                                          testing; Electromagnetic
                                          compatibility (EMC) testing;
                                          Use life testing; Software
                                          verification, validation, and
                                          hazard analysis; and Labeling.
Hearing loss...........................  Non-clinical performance
                                          testing and Labeling.
------------------------------------------------------------------------

    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. 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).
    At the time of classification, extracorporeal shock wave devices 
for treatment of chronic wounds are for prescription use only. 
Prescription devices are exempt from the requirement for adequate 
directions for use for the layperson under section 502(f)(1) of the 
FD&C Act and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 
are met (referring to 21 U.S.C. 352(f)(1)).

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 and guidance. 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 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; 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 878

    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 
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for part 878 continues to read as follows:

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


0
2. Add Sec.  878.4685 to subpart E to read as follows:


Sec.  878.4685   Extracorporeal shock wave device for treatment of 
chronic wounds.

    (a) Identification. An extracorporeal shock wave device for 
treatment of chronic wounds is a prescription device that focuses 
acoustic shock waves onto the dermal tissue. The shock waves are 
generated inside the device and transferred to the body using an 
acoustic interface.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must be conducted to 
demonstrate that the system produces anticipated and reproducible 
acoustic pressure shock waves.
    (2) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (3) Performance data must demonstrate that the reusable components 
of the device can be reprocessed for subsequent use.
    (4) Performance data must be provided to demonstrate the 
electromagnetic compatibility and electrical safety of the device.
    (5) Software verification, validation, and hazard analysis must be 
performed.
    (6) Performance data must support the use life of the system by 
demonstrating continued system functionality over the labeled use life.
    (7) Physician labeling must include:
    (i) Information on how the device operates and the typical course 
of treatment;
    (ii) A detailed summary of the device's technical parameters;
    (iii) Validated methods and instructions for reprocessing of any 
reusable components; and
    (iv) Instructions for preventing hearing loss by use of hearing 
protection.
    (8) Patient labeling must include:
    (i) Relevant contraindications, warnings, precautions, adverse 
effects, and complications;
    (ii) Information on how the device operates and the typical course 
of treatment;

[[Page 9700]]

    (iii) The probable risks and benefits associated with the use of 
the device;
    (iv) Post-procedure care instructions; and
    (v) Alternative treatments.

    Dated: February 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04616 Filed 3-6-18; 8:45 am]
 BILLING CODE 4164-01-P