83 FR 54006 - Medical Devices; Anesthesiology Devices; Classification of the High Flow Humidified Oxygen Delivery Device
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 208 (October 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 208 (October 26, 2018)
| Page Range | 54006-54007 | |
| FR Document | 2018-23409 |
[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)] [Rules and Regulations] [Pages 54006-54007] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-23409] [[Page 54006]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 868 [Docket No. FDA-2018-N-3729] Medical Devices; Anesthesiology Devices; Classification of the High Flow Humidified Oxygen Delivery Device AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is classifying the high flow humidified oxygen delivery device 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 high flow humidified oxygen delivery device'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 26, 2018. The classification was applicable on April 10, 2018. FOR FURTHER INFORMATION CONTACT: Derya Coursey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2563, Silver Spring, MD 20993-0002, 240-402-6130, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Upon request, FDA has classified the high flow humidified oxygen delivery device 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 (see 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 January 3, 2017, Vapotherm, Inc. submitted a request for De Novo classification of the Precision Flow[supreg] HVNI. 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 April 10, 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 868.5454. We have named the generic type of device high flow humidified oxygen delivery device, and it is identified as a prescription device that delivers high flow oxygen with humidification for patients who are suffering from respiratory distress and/or hypoxemia. 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. [[Page 54007]] Table 1--High Flow Humidified Oxygen Delivery Device Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risks Mitigation measures ------------------------------------------------------------------------ Adverse tissue reaction................ Biocompatibility evaluation, Non-clinical performance testing, and Labeling. Interference with other devices........ Electromagnetic compatibility testing, Radiofrequency identification testing, and Labeling. Infection.............................. Cleaning validation and Labeling. Device software failure leading to Software verification, delayed initiation of therapy. validation, and hazard analysis; and Labeling. Device failure/malfunction leading to Non-clinical performance ineffective treatment. testing and Labeling. Electrical shock injury from device Electrical safety, thermal failure. safety, and mechanical safety testing. Use error/improper device use leading Labeling. to hypoxia or worsening hypercarbia. ------------------------------------------------------------------------ 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. At the time of classification, high flow humidified oxygen delivery devices are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 352(f)(1)). 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 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; 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 868 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 868 is amended as follows: PART 868--ANESTHESIOLOGY DEVICES 0 1. The authority citation for part 868 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 868.5454 to subpart F to read as follows: Sec. 868.5454 High flow humidified oxygen delivery device. (a) Identification. A high flow humidified oxygen delivery device is a prescription device that delivers high flow oxygen with humidification for patients who are suffering from respiratory distress and/or hypoxemia. (b) Classification. Class II (special controls). The special controls for this device are: (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, including the following: (i) Alarm testing must be performed; (ii) Continuous use thermal stability testing must be performed; (iii) Humidity output testing must be performed; and (iv) Blender performance testing must evaluate fraction of inspired oxygen (FiO2 ) blending accuracy. (3) Performance data must validate cleaning instructions for any reusable components of the device. (4) Electrical safety, thermal safety, mechanical safety, electromagnetic compatibility, and radiofrequency identification testing must be performed. (5) Software verification, validation, and hazard analysis must be performed. (6) Labeling must include: (i) A description of available FiO2 ranges for different flowrates and inlet gas pressures; (ii) Instructions for applicable flowrates for all intended populations; (iii) A warning that patients on high flow oxygen are acute and require appropriate monitoring, to include pulse oximetry; (iv) A warning regarding the risk of condensation at low set temperatures and certain flows; and (v) A description of all alarms and their functions. Dated: October 22, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-23409 Filed 10-25-18; 8:45 am] BILLING CODE 4164-01-P
![54006 Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Rules and Regulations
DEPARTMENT OF HEALTH AND within, class III and requires premarket We believe this De Novo classification
HUMAN SERVICES approval unless and until FDA takes an will enhance patients’ access to
action to classify or reclassify the device beneficial innovation, in part by
Food and Drug Administration (see 21 U.S.C. 360c(f)(1)). We refer to reducing regulatory burdens. When FDA
these devices as ‘‘postamendments classifies a device into class I or II via
21 CFR Part 868 devices’’ because they were not in the De Novo process, the device can
commercial distribution prior to the serve as a predicate for future devices of
[Docket No. FDA–2018–N–3729]
date of enactment of the Medical Device that type, including for 510(k)s (see 21
Medical Devices; Anesthesiology Amendments of 1976, which amended U.S.C. 360c(f)(2)(B)(i)). As a result, other
Devices; Classification of the High the Federal Food, Drug, and Cosmetic device sponsors do not have to submit
Flow Humidified Oxygen Delivery Act (FD&C Act). a De Novo request or premarket
Device FDA may take a variety of actions in
approval application to market a
appropriate circumstances to classify or
substantially equivalent device (see 21
AGENCY: Food and Drug Administration, reclassify a device into class I or II. We
U.S.C. 360c(i), defining ‘‘substantial
HHS. may issue an order finding a new device
to be substantially equivalent under equivalence’’). Instead, sponsors can use
ACTION: Final order. the less-burdensome 510(k) process,
section 513(i) of the FD&C Act (see 21
U.S.C. 360c(i)) to a predicate device that when necessary, to market their device.
SUMMARY: The Food and Drug
Administration (FDA or we) is does not require premarket approval. II. De Novo Classification
classifying the high flow humidified We determine whether a new device is
oxygen delivery device into class II substantially equivalent to a predicate On January 3, 2017, Vapotherm, Inc.
(special controls). The special controls by means of the procedures for submitted a request for De Novo
that apply to the device type are premarket notification under section classification of the Precision Flow®
identified in this order and will be part 510(k) of the FD&C Act (21 U.S.C. HVNI. FDA reviewed the request in
of the codified language for the high 360(k)) and part 807 (21 CFR part 807). order to classify the device under the
flow humidified oxygen delivery FDA may also classify a device criteria for classification set forth in
device’s classification. We are taking through ‘‘De Novo’’ classification, a section 513(a)(1) of the FD&C Act.
this action because we have determined common name for the process
authorized under section 513(f)(2) of the We classify devices into class II if
that classifying the device into class II
FD&C Act. Section 207 of the Food and general controls by themselves are
(special controls) will provide a
reasonable assurance of safety and Drug Administration Modernization Act insufficient to provide reasonable
effectiveness of the device. We believe of 1997 (Pub. L. 105–115) established assurance of safety and effectiveness,
this action will also enhance patients’ the first procedure for De Novo but there is sufficient information to
access to beneficial innovative devices, classification. Section 607 of the Food establish special controls that, in
in part by reducing regulatory burdens. and Drug Administration Safety and combination with the general controls,
Innovation Act (Pub. L. 112–144) provide reasonable assurance of the
DATES: This order is effective October
modified the De Novo application safety and effectiveness of the device for
26, 2018. The classification was
applicable on April 10, 2018. process by adding a second procedure. its intended use (see 21 U.S.C.
A device sponsor may utilize either 360c(a)(1)(B)). After review of the
FOR FURTHER INFORMATION CONTACT: procedure for De Novo classification. information submitted in the request,
Derya Coursey, Center for Devices and Under the first procedure, the person we determined that the device can be
Radiological Health, Food and Drug submits a 510(k) for a device that has classified into class II with the
Administration, 10903 New Hampshire not previously been classified. After establishment of special controls. FDA
Ave., Bldg. 66, Rm. 2563, Silver Spring, receiving an order from FDA classifying
MD 20993–0002, 240–402–6130, has determined that these special
the device into class III under section controls, in addition to the general
Derya.Coursey@fda.hhs.gov. 513(f)(1) of the FD&C Act, the person controls, will provide reasonable
SUPPLEMENTARY INFORMATION: then requests a classification under assurance of the safety and effectiveness
section 513(f)(2). of the device.
I. Background
Under the second procedure, rather
Upon request, FDA has classified the than first submitting a 510(k) and then Therefore, on April 10, 2018, FDA
high flow humidified oxygen delivery a request for classification, if the person issued an order to the requester
device as class II (special controls), determines that there is no legally classifying the device into class II. FDA
which we have determined will provide marketed device upon which to base a is codifying the classification of the
a reasonable assurance of safety and determination of substantial device by adding 21 CFR 868.5454. We
effectiveness. In addition, we believe equivalence, that person requests a have named the generic type of device
this action will enhance patients’ access classification under section 513(f)(2) of high flow humidified oxygen delivery
to beneficial innovation, in part by the FD&C Act. device, and it is identified as a
reducing regulatory burdens by placing Under either procedure for De Novo prescription device that delivers high
the device into a lower device class than classification, FDA is required to flow oxygen with humidification for
the automatic class III assignment. classify the device by written order patients who are suffering from
khammond on DSK30JT082PROD with RULES
The automatic assignment of class III within 120 days. The classification will respiratory distress and/or hypoxemia.
occurs by operation of law and without be according to the criteria under
any action by FDA, regardless of the section 513(a)(1) of the FD&C Act. FDA has identified the following risks
level of risk posed by the new device. Although the device was automatically to health associated specifically with
Any device that was not in commercial placed within class III, the De Novo this type of device and the measures
distribution before May 28, 1976, is classification is considered to be the required to mitigate these risks in
automatically classified as, and remains initial classification of the device. table 1.
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![Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Rules and Regulations 54007
TABLE 1—HIGH FLOW HUMIDIFIED OXYGEN DELIVERY DEVICE RISKS AND MITIGATION MEASURES
Identified risks Mitigation measures
Adverse tissue reaction ............................................................................ Biocompatibility evaluation, Non-clinical performance testing, and La-
beling.
Interference with other devices ................................................................ Electromagnetic compatibility testing, Radiofrequency identification test-
ing, and Labeling.
Infection .................................................................................................... Cleaning validation and Labeling.
Device software failure leading to delayed initiation of therapy .............. Software verification, validation, and hazard analysis; and Labeling.
Device failure/malfunction leading to ineffective treatment ...................... Non-clinical performance testing and Labeling.
Electrical shock injury from device failure ................................................ Electrical safety, thermal safety, and mechanical safety testing.
Use error/improper device use leading to hypoxia or worsening Labeling.
hypercarbia.
FDA has determined that special number 0910–0073; the collections of (ii) Continuous use thermal stability
controls, in combination with the information in 21 CFR part 814, testing must be performed;
general controls, address these risks to subparts A through E, regarding (iii) Humidity output testing must be
health and provide reasonable assurance premarket approval, have been performed; and
of safety and effectiveness. For a device approved under OMB control number (iv) Blender performance testing must
to fall within this classification, and 0910–0231; the collections of evaluate fraction of inspired oxygen
thus avoid automatic classification in information in part 807, subpart E, (FiO2) blending accuracy.
class III, it would have to comply with regarding premarket notification (3) Performance data must validate
the special controls named in this final submissions, have been approved under cleaning instructions for any reusable
order. The necessary special controls OMB control number 0910–0120; and components of the device.
appear in the regulation codified by this the collections of information in 21 CFR (4) Electrical safety, thermal safety,
order. This device is subject to part 801, regarding labeling, have been mechanical safety, electromagnetic
premarket notification requirements approved under OMB control number compatibility, and radiofrequency
under section 510(k) of the FD&C Act. 0910–0485. identification testing must be
At the time of classification, high flow performed.
humidified oxygen delivery devices are List of Subjects in 21 CFR Part 868 (5) Software verification, validation,
for prescription use only. Prescription Medical devices. and hazard analysis must be performed.
devices are exempt from the (6) Labeling must include:
Therefore, under the Federal Food, (i) A description of available FiO2
requirement for adequate directions for Drug, and Cosmetic Act and under
use for the layperson under section ranges for different flowrates and inlet
authority delegated to the Commissioner gas pressures;
502(f)(1) of the FD&C Act (21 U.S.C. of Food and Drugs, 21 CFR part 868 is
352(f)(1)) and 21 CFR 801.5, as long as (ii) Instructions for applicable
amended as follows: flowrates for all intended populations;
the conditions of 21 CFR 801.109 are
met (referring to 21 U.S.C. 352(f)(1)). (iii) A warning that patients on high
PART 868—ANESTHESIOLOGY flow oxygen are acute and require
III. Analysis of Environmental Impact DEVICES appropriate monitoring, to include
We have determined under 21 CFR pulse oximetry;
■ 1. The authority citation for part 868
25.34(b) that this action is of a type that (iv) A warning regarding the risk of
continues to read as follows:
does not individually or cumulatively condensation at low set temperatures
Authority: 21 U.S.C. 351, 360, 360c, 360e, and certain flows; and
have a significant effect on the human
360j, 360l, 371. (v) A description of all alarms and
environment. Therefore, neither an
environmental assessment nor an ■ 2. Add § 868.5454 to subpart F to read their functions.
environmental impact statement is as follows: Dated: October 22, 2018.
required. Leslie Kux,
§ 868.5454 High flow humidified oxygen
IV. Paperwork Reduction Act of 1995 delivery device. Associate Commissioner for Policy.
[FR Doc. 2018–23409 Filed 10–25–18; 8:45 am]
This final order establishes special (a) Identification. A high flow
BILLING CODE 4164–01–P
controls that refer to previously humidified oxygen delivery device is a
approved collections of information prescription device that delivers high
found in other FDA regulations and flow oxygen with humidification for
DEPARTMENT OF HEALTH AND
guidance. These collections of patients who are suffering from
HUMAN SERVICES
information are subject to review by the respiratory distress and/or hypoxemia.
Office of Management and Budget (b) Classification. Class II (special Food and Drug Administration
(OMB) under the Paperwork Reduction controls). The special controls for this
Act of 1995 (44 U.S.C. 3501–3520). The device are: 21 CFR Part 874
collections of information in the (1) The patient-contacting
guidance document ‘‘De Novo components of the device must be [Docket No. FDA–2018–N–3772]
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Classification Process (Evaluation of demonstrated to be biocompatible.
Medical Devices; Ear, Nose, and Throat
Automatic Class III Designation)’’ have (2) Non-clinical performance testing
Devices; Classification of the Active
been approved under OMB control must demonstrate that the device
Implantable Bone Conduction Hearing
number 0910–0844; the collections of performs as intended under anticipated
System
information in 21 CFR part 820, conditions for use, including the
regarding quality system regulation, following: AGENCY: Food and Drug Administration,
have been approved under OMB control (i) Alarm testing must be performed; HHS.
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Document Created: 2018-10-26 02:28:50
Document Modified: 2018-10-26 02:28:50
| 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 26, 2018. The classification was applicable on April 10, 2018. | |
| Contact | Derya Coursey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2563, Silver Spring, MD 20993-0002, 240-402-6130, [email protected] | |
| FR Citation | 83 FR 54006 |
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