83 FR 26575 - Medical Devices; General and Plastic Surgery Devices; Classification of the Microneedling Device for Aesthetic Use

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 111 (June 8, 2018)

Page Range		26575-26577
FR Document		2018-12335

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.

Federal Register, Volume 83 Issue 111 (Friday, June 8, 2018)

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


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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, Kimberly.Ferlin@fda.hhs.gov.

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

26576 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Rules and Regulations

have determined will provide a Administration Safety and Innovation II. De Novo Classification
reasonable assurance of safety and Act modified the De Novo application
effectiveness. In addition, we believe process by adding a second procedure On July 5, 2016, Bellus Medical, LLC,
this action will enhance patients’ access (Pub. L. 112–144). A device sponsor submitted a request for De Novo
to beneficial innovation, in part by may utilize either procedure for De classification of the SkinPen Precision
reducing regulatory burdens by placing Novo classification. System. FDA reviewed the request in
the device into a lower device class than Under the first procedure, the person order to classify the device under the
the automatic class III assignment. submits a 510(k) for a device that has criteria for classification set forth in
The automatic assignment of class III not previously been classified. After section 513(a)(1) of the FD&C Act.
occurs by operation of law and without receiving an order from FDA classifying We classify devices into class II if
any action by FDA, regardless of the the device into class III under section general controls by themselves are
level of risk posed by the new device. 513(f)(1) of the FD&C Act, the person insufficient to provide reasonable
Any device that was not in commercial then requests a classification under assurance of safety and effectiveness,
distribution before May 28, 1976, is section 513(f)(2). but there is sufficient information to
automatically classified as, and remains Under the second procedure, rather
establish special controls that, in
within, class III and requires premarket than first submitting a 510(k) and then
a request for classification, if the person combination with the general controls,
approval unless and until FDA takes an provide reasonable assurance of the
action to classify or reclassify the device determines that there is no legally
marketed device upon which to base a safety and effectiveness of the device for
(see 21 U.S.C. 360c(f)(1)). We refer to its intended use (see 21 U.S.C.
these devices as ‘‘postamendments determination of substantial
equivalence, that person requests a 360c(a)(1)(B)). After review of the
devices’’ because they were not in information submitted in the request,
commercial distribution prior to the classification under section 513(f)(2) of
the FD&C Act. we determined that the device can be
date of enactment of the Medical Device classified into class II with the
Under either procedure for De Novo
Amendments of 1976, which amended establishment of special controls. FDA
classification, FDA shall classify the
the Federal Food, Drug, and Cosmetic device by written order within 120 days. has determined that these special
Act (FD&C Act). The classification will be according to controls, in addition to the general
FDA may take a variety of actions in the criteria under section 513(a)(1) of controls, will provide reasonable
appropriate circumstances to classify or the FD&C Act. Although the device was assurance of the safety and effectiveness
reclassify a device into class I or II. We automatically placed within class III, of the device.
may issue an order finding a new device the De Novo classification is considered
to be substantially equivalent under Therefore, on March 1, 2018, FDA
to be the initial classification of the issued an order to the requester
section 513(i) of the FD&C Act (21 device.
U.S.C. 360c(i)) to a predicate device that classifying the device into class II. FDA
We believe this De Novo classification is codifying the classification of the
does not require premarket approval. will enhance patients’ access to
We determine whether a new device is device by adding 21 CFR 878.4430. We
beneficial innovation, in part by have named the generic type of device
substantially equivalent to a predicate reducing regulatory burdens. When FDA
by means of the procedures for microneedling device for aesthetic use,
classifies a device into class I or II via
premarket notification under section and it is identified as a device using one
the De Novo process, the device can
510(k) of the FD&C Act (21 U.S.C. or more needles to mechanically
serve as a predicate for future devices of
360(k)) and part 807 (21 CFR part 807). puncture and injure skin tissue for
that type, including for 510(k)s (see 21
FDA may also classify a device U.S.C. 360c(f)(2)(B)(i)). As a result, other aesthetic use. This classification does
through ‘‘De Novo’’ classification, a device sponsors do not have to submit not include devices intended for
common name for the process a De Novo request or premarket transdermal delivery of topical products
authorized under section 513(f)(2) of the approval application in order to market such as cosmetics, drugs, or biologics.
FD&C Act. Section 207 of the Food and a substantially equivalent device (see 21 FDA has identified the following risks
Drug Administration Modernization Act U.S.C. 360c(i), defining ‘‘substantial to health associated specifically with
of 1997 established the first procedure equivalence’’). Instead, sponsors can use this type of device and the measures
for De Novo classification (Pub. L. 105– the less burdensome 510(k) process, required to mitigate these risks in
115). Section 607 of the Food and Drug when necessary, to market their device. 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 perform-
ance testing, Shelf life testing, and Labeling.
Electrical shock or electromagnetic interference with other devices ....... Electromagnetic compatibility testing, Electrical safety testing, and La-
beling.
Damage to underlying tissue including nerves and blood vessels, scar- Non-clinical performance testing, Technological characteristics, Shelf
ring, and hyper/hypopigmentation due to: life testing, Labeling, and Software verification, validation, and haz-
• Exceeding safe penetration depth ard analysis.
• Mechanical failure
amozie on DSK3GDR082PROD with RULES

• Software malfunction

FDA has determined that special health and provide reasonable assurance thus avoid automatic classification in
controls, in combination with the of safety and effectiveness. For a device class III, it would have to comply with
general controls, address these risks to to fall within this classification, and the special controls named in this final

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Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Rules and Regulations 26577

order. The necessary special controls puncture and injure skin tissue for (i) Information on how the device
appear in the regulation codified by this aesthetic use. This classification does operates and the typical course of
order. This device is subject to not include devices intended for treatment;
premarket notification requirements transdermal delivery of topical products (ii) The probable risks and benefits
under section 510(k) of the FD&C Act. such as cosmetics, drugs, or biologics. associated with use of the device; and
(b) Classification. Class II (special (iii) Postoperative care instructions.
III. Analysis of Environmental Impact
controls). The special controls for this Dated: June 4, 2018.
The Agency has determined under 21 device are: Leslie Kux,
CFR 25.34(b) that this action is of a type (1) The technical specifications and Associate Commissioner for Policy.
that does not individually or needle characteristics must be
cumulatively have a significant effect on [FR Doc. 2018–12335 Filed 6–7–18; 8:45 am]
identified, including needle length,
the human environment. Therefore, geometry, maximum penetration depth, BILLING CODE 4164–01–P

neither an environmental assessment and puncture rate.
nor an environmental impact statement (2) Non-clinical performance data
is required. DEPARTMENT OF HEALTH AND
must demonstrate that the device HUMAN SERVICES
IV. Paperwork Reduction Act of 1995 performs as intended under anticipated
conditions of use. The following Food and Drug Administration
This final order establishes special performance characteristics must be
controls that refer to previously tested:
approved collections of information 21 CFR Part 888
(i) Accuracy of needle penetration
found in other FDA regulations and depth and puncture rate; [Docket No. FDA–2018–N–1863]
guidance. These collections of (ii) Safety features built into the
information are subject to review by the Medical Devices; Orthopedic Devices;
device to protect against cross- Classification of the In Vivo Cured
Office of Management and Budget contamination, including fluid ingress
(OMB) under the Paperwork Reduction Intramedullary Fixation Rod
protection; and
Act of 1995 (44 U.S.C. 3501–3520). The (iii) Identification of the maximum AGENCY: Food and Drug Administration,
collections of information in the safe needle penetration depth for the HHS.
guidance document ‘‘De Novo device for the labeled indications for
Classification Process (Evaluation of ACTION: Final order.
use.
Automatic Class III Designation)’’ have SUMMARY: The Food and Drug
(3) Performance data must
been approved under OMB control Administration (FDA or we) is
demonstrate the sterility of the patient-
number 0910–0844; the collections of classifying the in vivo cured
contacting components of the device.
information in 21 CFR part 814, intramedullary fixation rod into class II
(4) Performance data must support the
subparts A through E, regarding (special controls). The special controls
shelf life of the device by demonstrating
premarket approval, have been that apply to the device type are
continued sterility, package integrity,
approved under OMB control number identified in this order and will be part
and device functionality over the
0910–0231; the collections of of the codified language for the in vivo
intended shelf life.
information in part 807, subpart E, cured intramedullary fixation rod’s
(5) Performance data must
regarding premarket notification classification. We are taking this action
demonstrate the electrical safety and
submissions, have been approved under because we have determined that
electromagnetic compatibility (EMC) of
OMB control number 0910–0120; and classifying the device into class II
all electrical components of the device.
the collections of information in 21 CFR (special controls) will provide a
(6) Software verification, validation,
part 801, regarding labeling, have been reasonable assurance of safety and
and hazard analysis must be performed
approved under OMB control number effectiveness of the device. We believe
for all software components of the
0910–0485. this action will also enhance patients’
device.
List of Subjects in 21 CFR Part 878 (7) The patient-contacting access to beneficial innovative devices,
components of the device must be in part by reducing regulatory burdens.
Medical devices.
demonstrated to be biocompatible. DATES: This order is effective June 8,
Therefore, under the Federal Food,
(8) Performance data must validate 2018. The classification was applicable
Drug, and Cosmetic Act and under
the cleaning and disinfection on December 19, 2017.
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 878 is instructions for reusable components of FOR FURTHER INFORMATION CONTACT:
amended as follows: the device. Peter Allen, Center for Devices and
(9) Labeling must include the Radiological Health, Food and Drug
PART 878—GENERAL AND PLASTIC following: Administration, 10903 New Hampshire
SURGERY DEVICES (i) Information on how to operate the Ave., Bldg. 66, Rm. 1512, Silver Spring,
device and its components and the MD 20993–0002, 301–796–6402,
■ 1. The authority citation for part 878 typical course of treatment; Peter.Allen@fda.hhs.gov.
continues to read as follows: (ii) A summary of the device technical SUPPLEMENTARY INFORMATION:
Authority: 21 U.S.C. 351, 360, 360c, 360e, parameters, including needle length,
360j, 360l, 371. needle geometry, maximum penetration I. Background
■ 2. Add § 878.4430 to subpart E to read depth, and puncture rate; Upon request, FDA has classified the
(iii) Validated methods and in vivo cured intramedullary fixation
amozie on DSK3GDR082PROD with RULES

as follows:
instructions for reprocessing of any rod as class II (special controls), which
§ 878.4430 Microneedling device for reusable components; we have determined will provide a
aesthetic use. (iv) Disposal instructions; and reasonable assurance of safety and
(a) Identification. A microneedling (v) A shelf life. effectiveness. In addition, we believe
device for aesthetic use is a device using (10) Patient labeling must be provided this action will enhance patients’ access
one or more needles to mechanically and must include: to beneficial innovation, in part by

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Document Created: 2018-06-08 01:23:14
Document Modified: 2018-06-08 01:23:14

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final order.
Dates		This order is effective June 8, 2018. The classification was applicable on March 1, 2018.
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]
FR Citation		83 FR 26575

83 FR 26575 - Medical Devices; General and Plastic Surgery Devices; Classification of the Microneedling Device for Aesthetic Use

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 111 (June 8, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration