[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Rules and Regulations]
[Pages 26575-26577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12335]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2018-N-1900]


Medical Devices; General and Plastic Surgery Devices; 
Classification of the Microneedling Device for Aesthetic Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the microneedling device for aesthetic use 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 microneedling device for aesthetic use'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 June 8, 2018. The classification was 
applicable on March 1, 2018.

FOR FURTHER INFORMATION CONTACT: Kimberly Ferlin, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. G449, Silver Spring, MD, 20993-0002, 240-
402-1834, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the microneedling device for 
aesthetic use as class II (special controls), which we

[[Page 26576]]

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.

II. De Novo Classification

    On July 5, 2016, Bellus Medical, LLC, submitted a request for De 
Novo classification of the SkinPen Precision 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 the 
general controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on March 1, 2018, 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 878.4430. We have named 
the generic type of device microneedling device for aesthetic use, and 
it is identified as a device using one or more needles to mechanically 
puncture and injure skin tissue for aesthetic use. This classification 
does not include devices intended for transdermal delivery of topical 
products such as cosmetics, drugs, or biologics.
    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--Microneedling Device for Aesthetic Use Risks and Mitigation
                                Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction................  Biocompatibility evaluation and
                                          Labeling.
Cross-contamination and infection......  Sterilization validation,
                                          Reprocessing validation, Non-
                                          clinical performance testing,
                                          Shelf life testing, and
                                          Labeling.
Electrical shock or electromagnetic      Electromagnetic compatibility
 interference with other devices.         testing, Electrical safety
                                          testing, and Labeling.
Damage to underlying tissue including    Non-clinical performance
 nerves and blood vessels, scarring,      testing, Technological
 and hyper/hypopigmentation due to:       characteristics, Shelf life
 Exceeding safe penetration       testing, Labeling, and
 depth                                    Software verification,
 Mechanical failure               validation, and hazard
 Software malfunction             analysis.
------------------------------------------------------------------------

    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

[[Page 26577]]

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 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 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; 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.  878.4430 to subpart E to read as follows:


Sec.  878.4430  Microneedling device for aesthetic use.

    (a) Identification. A microneedling device for aesthetic use is a 
device using one or more needles to mechanically puncture and injure 
skin tissue for aesthetic use. This classification does not include 
devices intended for transdermal delivery of topical products such as 
cosmetics, drugs, or biologics.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The technical specifications and needle characteristics must be 
identified, including needle length, geometry, maximum penetration 
depth, and puncture rate.
    (2) Non-clinical performance data must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be tested:
    (i) Accuracy of needle penetration depth and puncture rate;
    (ii) Safety features built into the device to protect against 
cross-contamination, including fluid ingress protection; and
    (iii) Identification of the maximum safe needle penetration depth 
for the device for the labeled indications for use.
    (3) Performance data must demonstrate the sterility of the patient-
contacting components 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 intended shelf life.
    (5) Performance data must demonstrate the electrical safety and 
electromagnetic compatibility (EMC) of all electrical components of the 
device.
    (6) Software verification, validation, and hazard analysis must be 
performed for all software components of the device.
    (7) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (8) Performance data must validate the cleaning and disinfection 
instructions for reusable components of the device.
    (9) Labeling must include the following:
    (i) Information on how to operate the device and its components and 
the typical course of treatment;
    (ii) A summary of the device technical parameters, including needle 
length, needle geometry, maximum penetration depth, and puncture rate;
    (iii) Validated methods and instructions for reprocessing of any 
reusable components;
    (iv) Disposal instructions; and
    (v) A shelf life.
    (10) Patient labeling must be provided and must include:
    (i) Information on how the device operates and the typical course 
of treatment;
    (ii) The probable risks and benefits associated with use of the 
device; and
    (iii) Postoperative care instructions.

    Dated: June 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12335 Filed 6-7-18; 8:45 am]
 BILLING CODE 4164-01-P


