52968 Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Rules and Regulations 
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, 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 § 878.4165 to subpart E to read 
as follows: 
§ 878.4165 Wound autofluorescence 
imaging device. 
(a) Identification. A wound 
autofluorescence imaging device is a 
tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information. 
(b) Classification. Class I (general 
controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9. 
Dated: October 16, 2018. 
Leslie Kux, 
Associate Commissioner for Policy. 
[FR Doc. 2018–22837 Filed 10–18–18; 8:45 am] 
BILLING CODE 4164–01–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Part 878 
[Docket No. FDA–2018–N–3598] 
Medical Devices; General and Plastic 
Surgery Devices; Classification of the Light Based Energy Source Device for Topical Application 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Final order. 
SUMMARY : The Food and Drug 
Administration (FDA or we) is classifying the light based energy source device for topical application 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 light based energy source device for topical application’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 October 
19, 2018. The classification was applicable on October 18, 2012. 
FOR FURTHER INFORMATION CONTACT : Neil 
Ogden, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G414, Silver Spring, MD, 20993–0002, 301–796–6397, Neil.Ogden@fda.hhs.gov. 
SUPPLEMENTARY INFORMATION : 
I. Background 
Upon request, FDA has classified the 
light based energy source device for topical application 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 (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 (Pub. L. 105–115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112–144) modified the De Novo application process by adding a second procedure. 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 (PMA) 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 
For this device, FDA issued an order 
on June 10, 2009, finding the ViruLite 
Cold Sore Machine not substantially equivalent to a predicate not subject to PMA. Thus, the device remained in class III in accordance with section 513(f)(1) of the FD&C Act when we issued the order. 
On June 30, 2009, Pacer Therapeutics, 
Ltd. submitted a request for De Novo classification of the ViruLite Cold Sore Machine. FDA reviewed the request in 
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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 October 18, 2012, 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 878.4860. We have named the generic type of device 
light based energy source device for topical application, and it is identified as a device that emits light energy at near infrared spectrum and is applied externally to the surface of herpes simplex labialis lesions on or around the lips. 
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—L IGHT BASED ENERGY SOURCE DEVICE FOR TOPICAL APPLICATION RISKS AND MITIGATION MEASURES  
Identified risks Mitigation measures 
Redness and discomfort ........................................................................... Clinical performance testing, Usability testing, and Labeling. 
Burns and blisters ..................................................................................... Clinical performance testing, Usability testing, and Labeling. 
Adverse tissue reaction ............................................................................ Biocompatibility evaluation.  
Infection/transmissibility ............................................................................ Labeling, Cleaning and disinfection validation, and Usability testing. 
Electrical shock ......................................................................................... Electrical safety testing and Labeling. 
Electromagnetic incompatibility ................................................................ Electromagnetic compatibility testing and Labeling. 
User error ................................................................................................. Usability testing and Labeling. 
Ocular injury ............................................................................................. Labeling and Non-clinical performance testing for ocular safety. 
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) of the FD&C Act. 
III. Analysis of Environmental Impact 
We have 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 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910–0073; 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 § 878.4860 to subpart E to read 
as follows: 
§ 878.4860 Light based energy source 
device for topical application. 
(a) Identification. The device emits 
light energy at near infrared spectrum 
and is applied externally to the surface of herpes simplex labialis lesions on or 
around the lips. 
(b) Classification. Class II (special 
controls). The special controls for this device are: 
(1) The technical parameters of the 
device, including wavelength, treatment time, treatment area, energy density, spot size, and power, must be characterized. 
(2) The cleaning and disinfection 
instructions for the device must be validated. 
(3) The device must be demonstrated 
to be biocompatible. 
(4) Performance testing must validate 
electromagnetic compatibility (EMC), ocular safety, and electrical safety of the device. 
(5) Labeling must direct end-users to 
contact the device manufacturer and MedWatch if they experience any adverse events when using this device. 
(6) Labeling must include specific 
information pertinent to use of the device by the intended patient population and the treatment regimen. 
(7) Simulated use testing must 
include information from a usability, 
label comprehension and self-selection study to demonstrate that the device can be used by the intended patient population without any assistance. 
(8) Clinical data must show adequate 
reduction in time to healing and assess risks of redness, discomfort, burns, and blisters. 
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Dated: October 15, 2018. 
Leslie Kux, 
Associate Commissioner for Policy. 
[FR Doc. 2018–22786 Filed 10–18–18; 8:45 am] 
BILLING CODE 4164–01–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Part 878 
[Docket No. FDA–2018–N–3595] 
Medical Devices; General and Plastic 
Surgery Devices; Classification of the Hemostatic Device for Intraluminal Gastrointestinal Use 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Final order. 
SUMMARY : The Food and Drug 
Administration (FDA or we) is classifying the hemostatic device for intraluminal gastrointestinal 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 hemostatic device for intraluminal gastrointestinal 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 October 
19, 2018. The classification was applicable on May 7, 2018. 
FOR FURTHER INFORMATION CONTACT : 
Maegen Colehour, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G423, Silver Spring, MD, 20993–0002, 301–796–6436, Maegen.Colehour@fda.hhs.gov . 
SUPPLEMENTARY INFORMATION : 
I. Background 
Upon request, FDA has classified the 
hemostatic device for intraluminal gastrointestinal use 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 (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 (Pub. L. 105–115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112–144) 
modified the De Novo application process by adding a second procedure. 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 is required to 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 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 March 9, 2017, Wilson-Cook 
Medical, Inc. submitted a request for De 
Novo classification of the Hemospray
® 
Endoscopic Hemostat. 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 May 7, 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 878.4456. We have named the generic type of device hemostatic device for intraluminal gastrointestinal use, and it is identified as a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other means. 
FDA has identified the following risks 
to health associated specifically with this type of device and the measures 
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