83 FR 52964 - Medical Devices; Anesthesiology Devices; Classification of the Positive Airway Pressure Delivery System
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 | 52964-52966 | |
| FR Document | 2018-22840 |
[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)] [Rules and Regulations] [Pages 52964-52966] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22840] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 868 [Docket No. FDA-2018-N-3684] Medical Devices; Anesthesiology Devices; Classification of the Positive Airway Pressure Delivery System AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: 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. DATES: This order is effective October 19, 2018. The classification was applicable on June 5, 2018. 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, [email protected]. SUPPLEMENTARY INFORMATION: [[Page 52965]] I. Background 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. 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 Electromagnetic compatibility devices. testing, and Labeling. Infection.............................. Reprocessing validation, and Labeling. Device software failure leading to Software verification, ineffective treatment. validation, and hazard analysis. Device hardware failure/malfunction Non-clinical performance leading to high airway pressure, testing, and Labeling. carbon dioxide rebreathing or ineffective treatment. Electrical shock injury or thermal Electrical safety, thermal injury. safety, and mechanical testing; Software verification, validation, and hazard analysis; and Labeling. Use error leading to ineffective Labeling. therapy or patient injury. ------------------------------------------------------------------------ [[Page 52966]] 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. 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, 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. 868.5273 to subpart F to read as follows: Sec. 868.5273 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. Dated: October 16, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-22840 Filed 10-18-18; 8:45 am] BILLING CODE 4164-01-P
![52964 Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Rules and Regulations
publish notice of a rulemaking in the In accordance with the foregoing, title shall be deemed to have satisfied the
Federal Register and provide an 17, chapter II of the Code of Federal filing deadline for such report or form
opportunity for public comment. This Regulations is amended as follows: if the issuer files such report or form
requirement does not apply, however, if with the Commission on or before
the agency ‘‘for good cause finds . . . PART 227—REGULATION November 23, 2018.
that notice and public procedure are CROWDFUNDING, GENERAL RULES (2) In any report or form filed
impracticable, unnecessary, or contrary AND REGULATIONS pursuant to paragraph (g)(1) of this
to the public interest.’’ 11 The APA also section, the issuer must disclose that it
generally requires that an agency ■ 1. The authority citation for part 227 is relying on this paragraph (g) and state
publish an adopted rule in the Federal is revised to read as follows: the reasons why, in good faith, it could
Register at least 30 days before it Authority: 15 U.S.C. 77d, 77d–1, 77s, 77z– not file such report or form on a timely
becomes effective. This requirement 3, 78c, 78o, 78q, 78w, 78mm, and Pub. L. basis.
does not apply, however, if the agency 112–106, secs. 301–305, 126 Stat. 306 (2012).
By the Commission.
finds good cause for making the rule ■ 2. Amend § 227.202 by adding Dated: October 16, 2018.
effective sooner.12 paragraph (d) to read as follows: Brent J. Fields,
Given the temporary nature of the Secretary.
relief contemplated by the interim final § 227.202 Ongoing reporting requirements.
* * * * * [FR Doc. 2018–22930 Filed 10–17–18; 4:15 pm]
temporary rules and the significant and
immediate impact of Hurricane Michael (d) Temporary relief from certain BILLING CODE 8011–01–P
and its aftermath on issuers in affected reporting requirements. (1) An issuer
areas, as discussed above, the that is not able to meet a filing deadline
Commission finds that good cause exists for any report or form required to be DEPARTMENT OF HEALTH AND
to dispense with notice and comment as filed by this section, 17 CFR HUMAN SERVICES
impracticable and unnecessary, and to 227.203(a)(3)), or 17 CFR 227.203(b)
act immediately to amend Rule 202 of during the period from and including Food and Drug Administration
Regulation Crowdfunding and Rule 257 October 10, 2018 to and including
of Regulation A.13 Further, the interim November 21, 2018 due to Hurricane 21 CFR Part 868
final temporary rules will not affect the Michael and its aftermath shall be
burden or cost estimates associated with deemed to have satisfied the filing [Docket No. FDA–2018–N–3684]
existing collections of information deadline for such report or form if the
under Regulation Crowdfunding and issuer files such report or form with the Medical Devices; Anesthesiology
Regulation A for purposes of the Commission on or before November 23, Devices; Classification of the Positive
Paperwork Reduction Act of 1995.14 2018. Airway Pressure Delivery System
(2) In any report or form filed
V. Statutory Basis and Text of pursuant to paragraph (d)(1) of this AGENCY: Food and Drug Administration,
Amendments section, the issuer must disclose that it HHS.
is relying on this paragraph (d) and state ACTION: Final order.
We are adopting amendments to Rule
202 of Regulation Crowdfunding and the reasons why, in good faith, it could
SUMMARY: The Food and Drug
Rule 257 of Regulation A under the not file such report or form on a timely
Administration (FDA or we) is
authority set forth in the Securities Act basis.
classifying the positive airway pressure
(15 U.S.C. 77a et seq.), particularly, PART 230—GENERAL RULES AND delivery system into class II (special
Section 28 thereof. REGULATIONS, SECURITIES ACT OF controls). The special controls that
List of Subjects 1933 apply to the device type are identified
in this order and will be part of the
17 CFR Part 227 ■ 3. The authority citation for part 230 codified language for the positive
continues to read in part as follows: airway pressure delivery system’s
Crowdfunding, Funding portals,
Authority: 15 U.S.C. 77b, 77b note, 77c, classification. We are taking this action
Intermediaries, Reporting and
77d, 77f, 77g, 77h, 77j, 77r, 77s, 77z–3, 77sss, because we have determined that
recordkeeping requirements, Securities.
78c, 78d, 78j, 78l, 78m, 78n, 78o, 78o–7 note, classifying the device into class II
17 CFR Part 230 78t, 78w, 78ll(d), 78mm, 80a–8, 80a–24, 80a– (special controls) will provide a
28, 80a–29, 80a–30, and 80a–37, and Pub. L. reasonable assurance of safety and
Reporting and recordkeeping 112–106, sec. 201(a), sec. 401, 126 Stat. 313 effectiveness of the device. We believe
requirements, Securities. (2012), unless otherwise noted. this action will also enhance patients’
* * * * * access to beneficial innovative devices,
11 5 U.S.C. 553(b)(3)(B).
12 5
■ 4. Amend § 230.257 by adding in part by reducing regulatory burdens.
U.S.C. 553(d)(3).
13 This finding also satisfies the requirements of paragraph (g) to read as follows: DATES: This order is effective October
5 U.S.C. 808(2), allowing the interim final 19, 2018. The classification was
§ 230.257 Periodic and current reporting;
temporary rules to become effective
exit report.
applicable on June 5, 2018.
notwithstanding the requirement of 5 U.S.C. 801 (if
FOR FURTHER INFORMATION CONTACT:
a federal agency finds that notice and public (g) Temporary relief from ongoing
comment are impractical, unnecessary or contrary reporting requirements. (1) An issuer Deepika Arora Lakhani, Center for
to the public interest, a rule shall take effect at such
that is not able to meet a filing deadline Devices and Radiological Health, Food
amozie on DSK3GDR082PROD with RULES
time as the federal agency promulgating the rule and Drug Administration, 10903 New
determines). The interim final temporary rules also for any report or form required to be
do not require analysis under the Regulatory filed by 17 CFR 230.252(f)(2)(i) or this Hampshire Ave., Bldg. 66, Rm. 2543,
Flexibility Act. See 5 U.S.C. 604(a) (requiring a final section during the period from and Silver Spring, MD 20993–0002, 301–
regulatory flexibility analysis only for rules
including October 10, 2018 to and 796–4042, Deepika.Lakhani@
required by the APA or other law to undergo notice fda.hhs.gov.
and comment). including November 21, 2018 due to
14 44 U.S.C. 3501 et seq. Hurricane Michael and its aftermath SUPPLEMENTARY INFORMATION:
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![52966 Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Rules and Regulations
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:
VerDate Sep<11>2014 16:11 Oct 18, 2018 Jkt 247001 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 E:\FR\FM\19OCR1.SGM 19OCR1](https://thefederalregister.org/doc/83_FR_53167/page/3.svg)
Document Created: 2018-10-19 01:25:54
Document Modified: 2018-10-19 01:25:54
| 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 June 5, 2018. | |
| 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, [email protected] | |
| FR Citation | 83 FR 52964 |
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