26575 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Rules and Regulations 
[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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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—M ICRONEEDLING DEVICE FOR AESTHETIC USERISKS AND MITIGATION MEASURES  
Identified risks Mitigation measures 
Adverse tissue reaction ............................................................................ Biocompatibility evaluation and Labeling. 
Cross-contamination and infection ........................................................... Sterilization validation, Reprocess ing validation, Non-clinical perform-
ance testing, Shelf life testing, and Labeling. 
Electrical shock or electromagnetic interference with other devices ....... Electromagnetic compatibility testing, Electrical saf ety testing, and La-
beling. 
Damage to underlying tissue including nerves and blood vessels, scar-
ring, 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 haz-ard 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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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 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 
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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