83 FR 52968 - Medical Devices; General and Plastic Surgery Devices; Classification of the Light Based Energy Source Device for Topical Application
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 203 (October 19, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 203 (October 19, 2018)
| Page Range | 52968-52970 | |
| FR Document | 2018-22786 |
[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)] [Rules and Regulations] [Pages 52968-52970] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22786] ----------------------------------------------------------------------- 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, [email protected]. 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 [[Page 52969]] 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--Light 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 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. 878.4860 to subpart E to read as follows: Sec. 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. [[Page 52970]] 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
![52968 Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Rules and Regulations
List of Subjects in 21 CFR Part 878 into class II (special controls) will FD&C Act. Section 207 of the Food and
Medical devices. provide a reasonable assurance of safety Drug Administration Modernization Act
and effectiveness of the device. We of 1997 (Pub. L. 105–115) established
Therefore, under the Federal Food,
believe this action will also enhance the first procedure for De Novo
Drug, and Cosmetic Act and under
patients’ access to beneficial innovative classification. Section 607 of the Food
authority delegated to the Commissioner
devices, in part by reducing regulatory and Drug Administration Safety and
of Food and Drugs, part 878 is amended
burdens. Innovation Act (Pub. L. 112–144)
as follows:
DATES: This order is effective October modified the De Novo application
PART 878—GENERAL AND PLASTIC 19, 2018. The classification was process by adding a second procedure.
SURGERY DEVICES applicable on October 18, 2012. A device sponsor may utilize either
FOR FURTHER INFORMATION CONTACT: Neil procedure for De Novo classification.
■ 1. The authority citation for part 878 Ogden, Center for Devices and Under the first procedure, the person
continues to read as follows: Radiological Health, Food and Drug submits a 510(k) for a device that has
not previously been classified. After
Authority: 21 U.S.C. 351, 360, 360c, 360e, Administration, 10903 New Hampshire
receiving an order from FDA classifying
360j, 360l, 371. Ave., Bldg. 66, Rm. G414, Silver Spring,
the device into class III under section
MD, 20993–0002, 301–796–6397,
■ 2. Add § 878.4165 to subpart E to read 513(f)(1) of the FD&C Act, the person
Neil.Ogden@fda.hhs.gov.
as follows: then requests a classification under
SUPPLEMENTARY INFORMATION: section 513(f)(2).
§ 878.4165 Wound autofluorescence Under the second procedure, rather
imaging device. I. Background
than first submitting a 510(k) and then
(a) Identification. A wound Upon request, FDA has classified the a request for classification, if the person
autofluorescence imaging device is a light based energy source device for determines that there is no legally
tool to view autofluorescence images topical application as class II (special marketed device upon which to base a
from skin wounds that are exposed to an controls), which we have determined determination of substantial
excitation light. The device is not will provide a reasonable assurance of equivalence, that person requests a
intended to provide quantitative or safety and effectiveness. In addition, we classification under section 513(f)(2) of
diagnostic information. believe this action will enhance the FD&C Act.
(b) Classification. Class I (general patients’ access to beneficial innovation, Under either procedure for De Novo
controls). The device is exempt from the in part by reducing regulatory burdens classification, FDA shall classify the
premarket notification procedures in by placing the device into a lower device by written order within 120 days.
subpart E of part 807 of this chapter, device class than the automatic class III The classification will be according to
subject to the limitations in § 878.9. assignment. the criteria under section 513(a)(1) of
Dated: October 16, 2018. The automatic assignment of class III the FD&C Act. Although the device was
Leslie Kux, occurs by operation of law and without automatically placed within class III,
Associate Commissioner for Policy.
any action by FDA, regardless of the the De Novo classification is considered
level of risk posed by the new device. to be the initial classification of the
[FR Doc. 2018–22837 Filed 10–18–18; 8:45 am]
Any device that was not in commercial device.
BILLING CODE 4164–01–P
distribution before May 28, 1976, is We believe this De Novo classification
automatically classified as, and remains will enhance patients’ access to
within, class III and requires premarket beneficial innovation, in part by
DEPARTMENT OF HEALTH AND
approval unless and until FDA takes an reducing regulatory burdens. When FDA
HUMAN SERVICES
action to classify or reclassify the device classifies a device into class I or II via
Food and Drug Administration (see 21 U.S.C. 360c(f)(1)). We refer to the De Novo process, the device can
these devices as ‘‘postamendments serve as a predicate for future devices of
21 CFR Part 878 devices’’ because they were not in that type, including for 510(k)s (see 21
commercial distribution prior to the U.S.C. 360c(f)(2)(B)(i)). As a result, other
[Docket No. FDA–2018–N–3598] date of enactment of the Medical Device device sponsors do not have to submit
Amendments of 1976, which amended a De Novo request or premarket
Medical Devices; General and Plastic
the Federal Food, Drug, and Cosmetic approval application (PMA) to market a
Surgery Devices; Classification of the
Act (FD&C Act). substantially equivalent device (see 21
Light Based Energy Source Device for FDA may take a variety of actions in
Topical Application U.S.C. 360c(i), defining ‘‘substantial
appropriate circumstances to classify or equivalence’’). Instead, sponsors can use
AGENCY: Food and Drug Administration, reclassify a device into class I or II. We the less-burdensome 510(k) process,
HHS. may issue an order finding a new device when necessary, to market their device.
ACTION: Final order. to be substantially equivalent under
section 513(i) of the FD&C Act (21 II. De Novo Classification
SUMMARY: The Food and Drug U.S.C. 360c(i)) to a predicate device that For this device, FDA issued an order
Administration (FDA or we) is does not require premarket approval. on June 10, 2009, finding the ViruLite
classifying the light based energy source We determine whether a new device is Cold Sore Machine not substantially
device for topical application into class substantially equivalent to a predicate equivalent to a predicate not subject to
II (special controls). The special controls by means of the procedures for PMA. Thus, the device remained in
that apply to the device type are premarket notification under section class III in accordance with section
amozie on DSK3GDR082PROD with RULES
identified in this order and will be part 510(k) of the FD&C Act (21 U.S.C. 513(f)(1) of the FD&C Act when we
of the codified language for the light 360(k)) and part 807 (21 CFR part 807). issued the order.
based energy source device for topical FDA may also classify a device On June 30, 2009, Pacer Therapeutics,
application’s classification. We are through ‘‘De Novo’’ classification, a Ltd. submitted a request for De Novo
taking this action because we have common name for the process classification of the ViruLite Cold Sore
determined that classifying the device authorized under section 513(f)(2) of the Machine. FDA reviewed the request in
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![52970 Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Rules and Regulations
Dated: October 15, 2018. The automatic assignment of class III section 513(a)(1) of the FD&C Act.
Leslie Kux, occurs by operation of law and without Although the device was automatically
Associate Commissioner for Policy. any action by FDA, regardless of the placed within class III, the De Novo
[FR Doc. 2018–22786 Filed 10–18–18; 8:45 am] level of risk posed by the new device. classification is considered to be the
BILLING CODE 4164–01–P
Any device that was not in commercial initial classification of the device.
distribution before May 28, 1976, is We believe this De Novo classification
automatically classified as, and remains will enhance patients’ access to
DEPARTMENT OF HEALTH AND within, class III and requires premarket beneficial innovation, in part by
HUMAN SERVICES approval unless and until FDA takes an reducing regulatory burdens. When FDA
action to classify or reclassify the device classifies a device into class I or II via
Food and Drug Administration (see 21 U.S.C. 360c(f)(1)). We refer to the De Novo process, the device can
these devices as ‘‘postamendments serve as a predicate for future devices of
21 CFR Part 878 devices’’ because they were not in that type, including for 510(k)s (see 21
commercial distribution prior to the U.S.C. 360c(f)(2)(B)(i)). As a result, other
[Docket No. FDA–2018–N–3595]
date of enactment of the Medical Device device sponsors do not have to submit
Medical Devices; General and Plastic Amendments of 1976, which amended a De Novo request or premarket
Surgery Devices; Classification of the the Federal Food, Drug, and Cosmetic approval application to market a
Hemostatic Device for Intraluminal Act (FD&C Act). substantially equivalent device (see 21
Gastrointestinal Use FDA may take a variety of actions in U.S.C. 360c(i), defining ‘‘substantial
appropriate circumstances to classify or equivalence’’). Instead, sponsors can use
AGENCY: Food and Drug Administration, reclassify a device into class I or II. We the less-burdensome 510(k) process,
HHS. may issue an order finding a new device when necessary, to market their device.
ACTION: Final order. to be substantially equivalent under
section 513(i) of the FD&C Act (21 II. De Novo Classification
SUMMARY: The Food and Drug U.S.C. 360c(i)) to a predicate device that On March 9, 2017, Wilson-Cook
Administration (FDA or we) is does not require premarket approval. Medical, Inc. submitted a request for De
classifying the hemostatic device for We determine whether a new device is Novo classification of the Hemospray®
intraluminal gastrointestinal use into substantially equivalent to a predicate Endoscopic Hemostat. FDA reviewed
class II (special controls). The special by means of the procedures for the request in order to classify the
controls that apply to the device type premarket notification under section device under the criteria for
are identified in this order and will be 510(k) of the FD&C Act (21 U.S.C. classification set forth in section
part of the codified language for the 360(k)) and part 807 (21 CFR part 807). 513(a)(1) of the FD&C Act.
hemostatic device for intraluminal FDA may also classify a device
through ‘‘De Novo’’ classification, a We classify devices into class II if
gastrointestinal use’s classification. We general controls by themselves are
are taking this action because we have common name for the process
authorized under section 513(f)(2) of the insufficient to provide reasonable
determined that classifying the device assurance of safety and effectiveness,
into class II (special controls) will FD&C Act. Section 207 of the Food and
Drug Administration Modernization Act but there is sufficient information to
provide a reasonable assurance of safety establish special controls that, in
and effectiveness of the device. We of 1997 (Pub. L. 105–115) established
the first procedure for De Novo combination with the general controls,
believe this action will also enhance provide reasonable assurance of the
patients’ access to beneficial innovative classification. Section 607 of the Food
and Drug Administration Safety and safety and effectiveness of the device for
devices, in part by reducing regulatory its intended use (see 21 U.S.C.
burdens. Innovation Act (Pub. L. 112–144)
modified the De Novo application 360c(a)(1)(B)). After review of the
DATES: This order is effective October information submitted in the request,
process by adding a second procedure.
19, 2018. The classification was we determined that the device can be
A device sponsor may utilize either
applicable on May 7, 2018. classified into class II with the
procedure for De Novo classification.
FOR FURTHER INFORMATION CONTACT: Under the first procedure, the person establishment of special controls. FDA
Maegen Colehour, Center for Devices submits a 510(k) for a device that has has determined that these special
and Radiological Health, Food and Drug not previously been classified. After controls, in addition to the general
Administration, 10903 New Hampshire receiving an order from FDA classifying controls, will provide reasonable
Ave., Bldg. 66, Rm. G423, Silver Spring, the device into class III under section assurance of the safety and effectiveness
MD, 20993–0002, 301–796–6436, 513(f)(1) of the FD&C Act, the person of the device.
Maegen.Colehour@fda.hhs.gov. then requests a classification under Therefore, on May 7, 2018, FDA
SUPPLEMENTARY INFORMATION: section 513(f)(2). issued an order to the requester
Under the second procedure, rather classifying the device into class II. FDA
I. Background is codifying the classification of the
than first submitting a 510(k) and then
Upon request, FDA has classified the a request for classification, if the person device by adding 21 CFR 878.4456. We
hemostatic device for intraluminal determines that there is no legally have named the generic type of device
gastrointestinal use as class II (special marketed device upon which to base a hemostatic device for intraluminal
controls), which we have determined determination of substantial gastrointestinal use, and it is identified
will provide a reasonable assurance of equivalence, that person requests a as a prescription device that is
safety and effectiveness. In addition, we classification under section 513(f)(2) of endoscopically applied to the upper
amozie on DSK3GDR082PROD with RULES
believe this action will enhance the FD&C Act. and/or lower gastrointestinal tract and is
patients’ access to beneficial innovation, Under either procedure for De Novo intended to produce hemostasis via
in part by reducing regulatory burdens classification, FDA is required to absorption of fluid or by other means.
by placing the device into a lower classify the device by written order FDA has identified the following risks
device class than the automatic class III within 120 days. The classification will to health associated specifically with
assignment. be according to the criteria under this type of device and the measures
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Document Created: 2018-10-19 01:25:53
Document Modified: 2018-10-19 01:25:53
| 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 October 19, 2018. The classification was applicable on October 18, 2012. | |
| 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, [email protected] | |
| FR Citation | 83 FR 52968 |
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