Food and Drug Administration, HHS.
The Food and Drug Administration (FDA or we) is classifying the positive airway pressure delivery system 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 positive airway pressure delivery system'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.
This order is effective October 19, 2018. The classification was applicable on June 5, 2018.
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FOR FURTHER INFORMATION CONTACT:
Deepika Arora Lakhani, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2543, Silver Spring, MD 20993-0002, 301-796-4042, Deepika.Lakhani@fda.hhs.gov.
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Upon request, FDA has classified the positive airway pressure delivery system 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 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 and 21 CFR part 807 (21 U.S.C. 360(k) and part 807, respectively).
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 December 14, 2017, FRESCA Medical submitted a request for De Novo classification of the CURVE TM Positive Airway Pressure System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on June 5, 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 868.5273. We have named the generic type of device positive airway pressure delivery system, and it is identified as a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface.
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.
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Table 1—Positive Airway Pressure Delivery System Risks and Mitigation Measures
|Identified risks||Mitigation measures|
|Adverse tissue reaction||Biocompatibility evaluation, and Labeling.|
|Electromagnetic interference with other devices||Electromagnetic compatibility testing, and Labeling.|
|Infection||Reprocessing validation, and Labeling.|
|Device software failure leading to ineffective treatment||Software verification, validation, and hazard analysis.|
|Device hardware failure/malfunction leading to high airway pressure, carbon dioxide rebreathing or ineffective treatment||Non-clinical performance testing, and Labeling.|
|Electrical shock injury or thermal injury||Electrical safety, thermal safety, and mechanical testing; Software verification, validation, and hazard analysis; and Labeling.|
|Use error leading to ineffective therapy or patient injury||Labeling.|
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. In order 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, positive airway pressure delivery systems 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 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
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collection 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 part 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.
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Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, part 868 is amended as follows:
PART 868—ANESTHESIOLOGY DEVICES
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1. The authority citation for part 868 continues to read as follows: End Amendment Part
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2. Add § 868.5273 to subpart F to read as follows: End Amendment Part
Positive airway pressure delivery system.
(a) Identification. A positive airway pressure delivery system is a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface.
(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 of use, including the following:
(i) Waveform testing must simulate breathing conditions and evaluate pressure and airflow response over a range and combination of high and low breath rates and tidal volumes.
(ii) Use life testing must demonstrate adequate device performance over the labeled use life of the device.
(iii) Device integrity testing must demonstrate that the device can withstand typical forces expected during use.
(iv) Carbon dioxide rebreathing testing must be performed.
(v) System flow rate, maximum expiratory pressure, inhalation pressure, and intra-mask static pressure testing must be performed.
(vi) Air bolus testing must demonstrate that the device can withstand worst-case scenario air pressures.
(vii) Maximum limited pressure testing of the flow generator in single fault condition must be performed.
(viii) Maximum output temperature testing of delivered gas, if humidified, must be performed.
(3) Performance data must validate reprocessing instructions for any reusable components of the device.
(4) Performance data must demonstrate the electrical, thermal, and mechanical safety and the electromagnetic compatibility of the device.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Labeling must include the following:
(i) Therapy pressure range;
(ii) Use life and replacement schedule for all components;
(iii) Cleaning instructions; and
(iv) Instructions for assembly and connection of device components.
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Dated: October 16, 2018.
Associate Commissioner for Policy.
[FR Doc. 2018-22840 Filed 10-18-18; 8:45 am]
BILLING CODE 4164-01-P