83 FR 52966 - Medical Devices; General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device
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 | 52966-52968 | |
| FR Document | 2018-22837 |
[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)] [Rules and Regulations] [Pages 52966-52968] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22837] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 [Docket No. FDA-2018-N-3696] Medical Devices; General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is classifying the wound autofluorescence imaging device into class I. We are taking this action because we have determined that classifying the device into class I 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 July 31, 2018. FOR FURTHER INFORMATION CONTACT: Yasaman Ardeshirpour, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G455, Silver Spring, MD, 20993-0002, 240-402-3706, [email protected]. SUPPLEMENTARY INFORMATION: [[Page 52967]] I. Background Upon request, FDA has classified the wound autofluorescence imaging device as class I (general 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 to a predicate device that does not require premarket approval (see 21 U.S.C. 360c(i)). 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 (21 U.S.C. 360c(f)(2)). 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 (21 U.S.C. 360c(a)(1)). Although the device was automatically 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 PMA 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 February 16, 2018, MolecuLight, Inc. submitted a request for De Novo classification of the MolecuLight i:X. 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 I if general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(A)). After review of the information submitted in the request, we determined that the device can be classified into class I. FDA has determined that general controls will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on July 31, 2018, FDA issued an order to the requester classifying the device into class I. FDA is codifying the classification of the device by adding 21 CFR 878.4165. We have named the generic type of device wound autofluorescence imaging device, and it is identified as 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. FDA has identified the following risks to health associated specifically with this type of device: electrical/mechanical/thermal, electromagnetic compatibility (EMC) and optical safety of the device, and the error in fluorescence detection from the wound. Section 510(l)(1) of the FD&C Act provides that a device within a type that has been classified into class I under section 513 of the FD&C Act is exempt from premarket notification under section 510(k), unless the device is of substantial importance in preventing impairment of human health or presents a potentially unreasonable risk of illness or injury (21 U.S.C. 360(l)(1)). Devices within this type are exempt from the premarket notification requirements under section 510(k), subject to the limitations of exemptions in 21 CFR 878.9. 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 refers 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 current good manufacturing practices, have been approved under OMB control number 0910-0073; and 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. [[Page 52968]] 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 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. 878.4165 to subpart E to read as follows: Sec. 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 Sec. 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
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FDA has determined that special List of Subjects in 21 CFR Part 868 (3) Performance data must validate
controls, in combination with the Medical devices. reprocessing instructions for any
general controls, address these risks to reusable components of the device.
health and provide reasonable assurance Therefore, under the Federal Food,
(4) Performance data must
of safety and effectiveness. In order for Drug, and Cosmetic Act and under
demonstrate the electrical, thermal, and
a device to fall within this classification, authority delegated to the Commissioner
mechanical safety and the
and thus avoid automatic classification of Food and Drugs, part 868 is amended
electromagnetic compatibility of the
in class III, it would have to comply as follows:
device.
with the special controls named in this PART 868—ANESTHESIOLOGY (5) Software verification, validation,
final order. The necessary special DEVICES and hazard analysis must be performed.
controls appear in the regulation (6) Labeling must include the
codified by this order. This device is ■ 1. The authority citation for part 868 following:
subject to premarket notification continues to read as follows: (i) Therapy pressure range;
requirements under section 510(k) of the Authority: 21 U.S.C. 351, 360, 360c, 360e, (ii) Use life and replacement schedule
FD&C Act. 360j, 360l, 371. for all components;
At the time of classification, positive
■ 2. Add § 868.5273 to subpart F to read (iii) Cleaning instructions; and
airway pressure delivery systems are for
as follows: (iv) Instructions for assembly and
prescription use only. Prescription
connection of device components.
devices are exempt from the
§ 868.5273 Positive airway pressure Dated: October 16, 2018.
requirement for adequate directions for delivery system.
use for the layperson under section Leslie Kux,
(a) Identification. A positive airway
502(f)(1) of the FD&C Act and 21 CFR Associate Commissioner for Policy.
pressure delivery system is a
801.5, as long as the conditions of 21 [FR Doc. 2018–22840 Filed 10–18–18; 8:45 am]
prescription noninvasive ventilatory
CFR 801.109 are met (referring to 21
device that delivers expiratory positive BILLING CODE 4164–01–P
U.S.C. 352(f)(1)).
airway pressure for patients suffering
III. Analysis of Environmental Impact from obstructive sleep apnea. The
system also provides positive airway DEPARTMENT OF HEALTH AND
The Agency has determined under 21 HUMAN SERVICES
CFR 25.34(b) that this action is of a type pressure during incipient apnea. The
that does not individually or system may include a dedicated flow Food and Drug Administration
cumulatively have a significant effect on generator and a patient interface.
the human environment. Therefore, (b) Classification. Class II (special
21 CFR Part 878
neither an environmental assessment controls). The special controls for this
nor an environmental impact statement device are:
(1) The patient-contacting [Docket No. FDA–2018–N–3696]
is required.
components of the device must be
IV. Paperwork Reduction Act of 1995 demonstrated to be biocompatible. Medical Devices; General and Plastic
(2) Non-clinical performance testing Surgery Devices; Classification of the
This final order establishes special Wound Autofluorescence Imaging
controls that refer to previously must demonstrate that the device
performs as intended under anticipated Device
approved collections of information
found in other FDA regulations and conditions of use, including the
AGENCY: Food and Drug Administration,
guidance. These collections of following:
HHS.
information are subject to review by the (i) Waveform testing must simulate
breathing conditions and evaluate ACTION: Final order.
Office of Management and Budget
(OMB) under the Paperwork Reduction pressure and airflow response over a
SUMMARY: The Food and Drug
Act of 1995 (44 U.S.C. 3501–3520). The range and combination of high and low
Administration (FDA or we) is
collections of information in the breath rates and tidal volumes.
(ii) Use life testing must demonstrate classifying the wound autofluorescence
guidance document ‘‘De Novo imaging device into class I. We are
adequate device performance over the
Classification Process (Evaluation of taking this action because we have
labeled use life of the device.
Automatic Class III Designation)’’ have (iii) Device integrity testing must determined that classifying the device
been approved under OMB control demonstrate that the device can into class I will provide a reasonable
number 0910–0844; the collections of withstand typical forces expected assurance of safety and effectiveness of
information in 21 CFR part 814, during use. the device. We believe this action will
subparts A through E, regarding (iv) Carbon dioxide rebreathing also enhance patients’ access to
premarket approval, have been testing must be performed. beneficial innovative devices, in part by
approved under OMB control number (v) System flow rate, maximum reducing regulatory burdens.
0910–0231; the collection of expiratory pressure, inhalation pressure, DATES: This order is effective October
information in 21 CFR part 820, and intra-mask static pressure testing 19, 2018. The classification was
regarding quality system regulation, must be performed. applicable on July 31, 2018.
have been approved under OMB control (vi) Air bolus testing must FOR FURTHER INFORMATION CONTACT:
number 0910–0073; the collections of demonstrate that the device can
information in part 807, subpart E, Yasaman Ardeshirpour, Center for
withstand worst-case scenario air Devices and Radiological Health, Food
regarding premarket notification pressures.
amozie on DSK3GDR082PROD with RULES
submissions, have been approved under and Drug Administration, 10903 New
(vii) Maximum limited pressure
OMB control number 0910–0120; and Hampshire Ave., Bldg. 66, Rm. G455,
testing of the flow generator in single
the collections of information in part 21 Silver Spring, MD, 20993–0002, 240–
fault condition must be performed.
CFR part 801, regarding labeling, have (viii) Maximum output temperature 402–3706, Yasaman.Ardeshirpour@
been approved under OMB control testing of delivered gas, if humidified, fda.hhs.gov.
number 0910–0485. must be performed. SUPPLEMENTARY INFORMATION:
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![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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Document Created: 2018-10-19 01:25:11
Document Modified: 2018-10-19 01:25:11
| 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 July 31, 2018. | |
| Contact | Yasaman Ardeshirpour, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G455, Silver Spring, MD, 20993-0002, 240-402-3706, [email protected] | |
| FR Citation | 83 FR 52966 |
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