Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Rules and Regulations 26575 

[FR Doc. 2018–12304 Filed 6–7–18; 8:45 am] 

BILLING CODE 4910–13–C 

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 


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

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 interference with other devices ....... Electromagnetic compatibility testing, Electrical safety testing, and Labeling. 

Damage to underlying tissue including nerves and blood vessels, scarring, and hyper/hypopigmentation due to: 

• Exceeding safe penetration depth 

• Mechanical failure 

• Software malfunction 

Non-clinical performance testing, Technological characteristics, Shelf 

life testing, Labeling, and Software verification, validation, and hazard 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 


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

■ 1. The authority citation for part 878 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 878.4430 to subpart E to read 

as follows: 

§ 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 crosscontamination, 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 patientcontacting 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 888 

[Docket No. FDA–2018–N–1863] 

Medical Devices; Orthopedic Devices; 

Classification of the In Vivo Cured 

Intramedullary Fixation Rod 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the in vivo cured 

intramedullary fixation rod 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 in vivo 

cured intramedullary fixation rod’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 December 19, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Peter Allen, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1512, Silver Spring, 

MD 20993–0002, 301–796–6402, 

Peter.Allen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

in vivo cured intramedullary fixation 

rod 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 


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