82 FR 35067 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 144 (July 28, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 144 (July 28, 2017)
| Page Range | 35067-35069 | |
| FR Document | 2017-15894 |
[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)] [Rules and Regulations] [Pages 35067-35069] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-15894] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 876 [Docket No. FDA-2017-N-1609] Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is classifying the oral removable palatal space occupying device for weight management and/or weight loss into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the oral removable palatal space occupying device for weight management and/or weight loss classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. DATES: This order is effective July 28, 2017. The classification was applicable on September 26, 2016. FOR FURTHER INFORMATION CONTACT: Mark Antonino, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G208, Silver Spring, MD, 20993-0002, 240-402-9980, mark.antonino@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially [[Page 35068]] equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations. Section 513(f)(2) of the FD&C Act, also known as De Novo classification, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1) of the FD&C Act. Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1), the person requests a classification under section 513(f)(2) of the FD&C Act. Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of ``low-moderate risk'' or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed. In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA shall classify the device by written order within 120 days. This classification will be the initial classification of the device. On July 31, 2015, Scientific Intake submitted a request for classification of the Sensor Monitored Alimentary Restriction Therapy (SMART) device under section 513(f)(2) of the FD&C Act. In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies 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 to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on September 26, 2016, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 876.5981. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for an oral removable palatal space occupying device for weight management and/or weight loss will need to comply with the special controls named in this final order. A De Novo classification decreases regulatory burdens. When FDA classifies a device type as class I or II via the De Novo pathway, other manufacturers do not have to submit a De Novo request or premarket approval application to market the same type of device, unless the device has a new intended use or technological characteristics that raise different questions of safety or effectiveness. Instead, manufacturers can use the less burdensome 510(k) pathway, when necessary, to market their device, and the device that was the subject of the original De Novo classification can serve as a predicate device for additional 510(k)s from other manufacturers. The device is assigned the generic name oral removable palatal space occupying device for weight management and/or weight loss, and it is identified as a prescription device that is worn during meals to limit bite size, thereby reducing the amount of food that is consumed. The device may contain recording sensors for monitoring patient use. This classification does not include devices that are intended to treat any dental diseases or conditions. 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--Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss Risks to Health and Mitigation Measures ------------------------------------------------------------------------ Identified risks Mitigation measures ------------------------------------------------------------------------ Tooth Movement, Irritation, Non-clinical performance testing. and Soreness of Mouth or Labeling. Gums, including: Training.Improper mold making; User error; and Damage to material (soft edge separation) Choking or gag reflex........ Clinical performance testing. Labeling. Adverse tissue reaction...... Biocompatibility evaluation. Incorrect data Non-clinical performance testing. interpretation, including: Labeling. Hardware malfunction Training. (sensor malfunction) Electrical shock and Non-clinical performance testing. electrical interference with other devices. Weight gain.................. Clinical performance testing. Labeling. ------------------------------------------------------------------------ FDA believes that the special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. Oral removable palatal space occupying devices for weight management and/or weight loss are not safe for use except under the supervision of a practitioner licensed by law to direct the use of the device. As such, the device is a prescription device and must satisfy prescription labeling requirements (see 21 CFR 801.109, Prescription devices). [[Page 35069]] Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k), if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA believes premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device type and, therefore, is planning to exempt the device from the premarket notification requirements under section 510(m) of the FD&C Act. Once finalized, persons who intend to market this device type need not submit a 510(k) premarket notification containing information on the oral removable palatal space occupying device for weight management and/or weight loss prior to marketing the device. II. 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. III. Paperwork Reduction Act of 1995 This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. 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 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 876 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 876 is amended as follows: PART 876--GASTROENTEROLOGY-UROLOGY DEVICES 0 1. The authority citation for part 876 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 876.5981 to subpart F to read as follows: Sec. 876.5981 Oral removable palatal space occupying device for weight management and/or weight loss. (a) Identification. An oral removable palatal space occupying device for weight management and/or weight loss is a prescription device that is worn during meals to limit bite size, thereby reducing the amount of food that is consumed. The device may contain recording sensors for monitoring patient use. This classification does not include devices that are intended to treat any dental diseases or conditions (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 for its intended use. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, as follows: (i) Mechanical testing must demonstrate that the device performs as intended for the labeled use life and does not create forces that result in movement of teeth and damage to teeth. (ii) Electrical safety and electromagnetic compatibility testing must demonstrate that the device performs as intended. (iii) Software verification and validation must demonstrate that the device performs as intended. (iv) Battery testing must demonstrate that the device battery performs as intended. (3) Clinical performance testing must demonstrate the device performs as intended and must include an evaluation for choking. (4) Device labeling must address the following: (i) Patient labeling must state: (A) The clinical benefit of weight management and/or weight loss as assessed by using percent total body weight loss; (B) Treatment must be offered in combination with a behavioral modification program; (C) Instructions on how to use the device as intended; and (D) The use life of the device. (ii) Physician labeling must state: (A) The clinical benefit of weight management and/or weight loss as assessed by using percent total body weight loss; (B) Treatment must be offered in combination with a behavioral modification program; (C) Instructions on how to use the device as intended; and (D) The use life of the device. (5) Training must be provided to health professionals that includes procedures for determining a patient's oral health status, instructions for making the palatal mold, and assessment of issues with the device that may require service by the manufacturer. Dated: July 24, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-15894 Filed 7-27-17; 8:45 am] BILLING CODE 4164-01-P
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information found in other FDA algorithm(s) must be provided. DEPARTMENT OF HEALTH AND
regulations. These collections of Verification of algorithm calculations HUMAN SERVICES
information are subject to review by the and validation testing of the algorithm
Office of Management and Budget using a data set separate from the Food and Drug Administration
(OMB) under the Paperwork Reduction training data must demonstrate the
Act of 1995 (44 U.S.C. 3501–3520). The validity of modeling. 21 CFR Part 876
collections of information in part 807, (3) Usability assessment must be
[Docket No. FDA–2017–N–1609]
subpart E, regarding premarket provided to demonstrate that risk of
notification submissions have been misinterpretation of the status indicator Medical Devices; Gastroenterology-
approved under OMB control number is appropriately mitigated. Urology Devices; Classification of the
0910–0120, and the collections of (4) Clinical data must be provided in Oral Removable Palatal Space
information in 21 CFR part 801, support of the intended use and include Occupying Device for Weight
regarding labeling have been approved the following: Management and/or Weight Loss
under OMB control number 0910–0485. (i) Output measure(s) must be
compared to an acceptable reference AGENCY: Food and Drug Administration,
List of Subjects in 21 CFR Part 870 method to demonstrate that the output HHS.
Medical devices. measure(s) represent(s) the predictive ACTION: Final order.
Therefore, under the Federal Food, measure(s) that the device provides in
Drug, and Cosmetic Act and under an accurate and reproducible manner; SUMMARY: The Food and Drug
authority delegated to the Commissioner (ii) The data set must be Administration (FDA or Agency) is
of Food and Drugs, 21 CFR part 870 is representative of the intended use classifying the oral removable palatal
population for the device. Any selection space occupying device for weight
amended as follows:
criteria or limitations of the samples management and/or weight loss into
PART 870—CARDIOVASCULAR must be fully described and justified; class II (special controls). The special
DEVICES (iii) Agreement of the measure(s) with controls that will apply to the device are
the reference measure(s) must be identified in this order and will be part
■ 1. The authority citation for part 870 assessed across the full measurement of the codified language for the oral
continues to read as follows: range; and removable palatal space occupying
(iv) Data must be provided within the device for weight management and/or
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
clinical validation study or using weight loss classification. The Agency is
equivalent datasets to demonstrate the classifying the device into class II
■ 2. Add § 870.2200 to subpart C to read consistency of the output and be
as follows: (special controls) in order to provide a
representative of the range of data reasonable assurance of safety and
sources and data quality likely to be
§ 870.2200 Adjunctive cardiovascular effectiveness of the device.
status indicator. encountered in the intended use
population and relevant use conditions DATES: This order is effective July 28,
(a) Identification. The adjunctive 2017. The classification was applicable
cardiovascular status indicator is a in the intended use environment.
(5) Labeling must include the on September 26, 2016.
prescription device based on sensor
following: FOR FURTHER INFORMATION CONTACT:
technology for the measurement of a (i) The type of sensor data used, Mark Antonino, Center for Devices and
physical parameter(s). This device is including specification of compatible Radiological Health, Food and Drug
intended for adjunctive use with other sensors for data acquisition; Administration, 10903 New Hampshire
physical vital sign parameters and (ii) A description of what the device Ave., Bldg. 66, Rm. G208, Silver Spring,
patient information and is not intended measures and outputs to the user; MD, 20993–0002, 240–402–9980,
to independently direct therapy. (iii) Warnings identifying sensor mark.antonino@fda.hhs.gov.
(b) Classification. Class II (special reading acquisition factors that may
controls). The special controls for this SUPPLEMENTARY INFORMATION:
impact measurement results;
device are: (iv) Guidance for interpretation of the I. Background
(1) Software description, verification, measurements, including warning(s)
and validation based on comprehensive In accordance with section 513(f)(1) of
specifying adjunctive use of the the Federal Food, Drug, and Cosmetic
hazard analysis must be provided, measurements;
including: Act (the FD&C Act) (21 U.S.C.
(v) Key assumptions made in the
(i) Full characterization of technical 360c(f)(1)), devices that were not in
calculation and determination of
parameters of the software, including commercial distribution before May 28,
measurements;
any proprietary algorithm(s); 1976 (the date of enactment of the
(vi) The measurement performance of
(ii) Description of the expected impact Medical Device Amendments of 1976),
the device for all presented parameters,
of all applicable sensor acquisition generally referred to as postamendments
with appropriate confidence intervals,
hardware characteristics on devices, are classified automatically by
and the supporting evidence for this
performance and any associated statute into class III without any FDA
performance; and
hardware specifications; (vii) A detailed description of the rulemaking process. These devices
(iii) Specification of acceptable patients studied in the clinical remain in class III and require
incoming sensor data quality control validation (e.g., age, gender, race/ premarket approval, unless and until
asabaliauskas on DSKBBXCHB2PROD with RULES
measures; and ethnicity, clinical stability) as well as the device is classified or reclassified
(iv) Mitigation of impact of user error procedural details of the clinical study. into class I or II, or FDA issues an order
or failure of any subsystem components finding the device to be substantially
(signal detection and analysis, data Dated: July 24, 2017. equivalent, in accordance with section
display, and storage) on accuracy of Leslie Kux, 513(i) of the FD&C Act, to a predicate
patient reports. Associate Commissioner for Policy. device that does not require premarket
(2) Scientific justification for the [FR Doc. 2017–15901 Filed 7–27–17; 8:45 am] approval. The Agency determines
validity of the status indicator BILLING CODE 4164–01–P whether new devices are substantially
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Section 510(m) of the FD&C Act § 876.5981 Oral removable palatal space procedures for determining a patient’s
provides that FDA may exempt a class occupying device for weight management oral health status, instructions for
II device from the premarket notification and/or weight loss. making the palatal mold, and
requirements under section 510(k), if (a) Identification. An oral removable assessment of issues with the device
FDA determines that premarket palatal space occupying device for that may require service by the
notification is not necessary to provide weight management and/or weight loss manufacturer.
reasonable assurance of the safety and is a prescription device that is worn
Dated: July 24, 2017.
effectiveness of the device. For this type during meals to limit bite size, thereby
reducing the amount of food that is Leslie Kux,
of device, FDA believes premarket
consumed. The device may contain Associate Commissioner for Policy.
notification is not necessary to provide
reasonable assurance of the safety and recording sensors for monitoring patient [FR Doc. 2017–15894 Filed 7–27–17; 8:45 am]
effectiveness of the device type and, use. This classification does not include BILLING CODE 4164–01–P
therefore, is planning to exempt the devices that are intended to treat any
device from the premarket notification dental diseases or conditions
requirements under section 510(m) of (b) Classification. Class II (special DEPARTMENT OF HEALTH AND
the FD&C Act. Once finalized, persons controls). The special controls for this HUMAN SERVICES
who intend to market this device type device are:
(1) The patient-contacting Food and Drug Administration
need not submit a 510(k) premarket
notification containing information on components of the device must be
demonstrated to be biocompatible for its 21 CFR Part 882
the oral removable palatal space
occupying device for weight intended use. [Docket No. FDA–2017–N–1608]
management and/or weight loss prior to (2) Non-clinical performance testing
marketing the device. must demonstrate that the device Medical Devices; Neurological
performs as intended under anticipated Devices; Classification of Cranial
II. Analysis of Environmental Impact conditions for use, as follows: Motion Measurement Device
The Agency has determined under 21 (i) Mechanical testing must
demonstrate that the device performs as AGENCY: Food and Drug Administration,
CFR 25.34(b) that this action is of a type
intended for the labeled use life and HHS.
that does not individually or
cumulatively have a significant effect on does not create forces that result in ACTION: Final order.
the human environment. Therefore, movement of teeth and damage to teeth. SUMMARY: The Food and Drug
neither an environmental assessment (ii) Electrical safety and
Administration (FDA or Agency) is
nor an environmental impact statement electromagnetic compatibility testing
classifying the cranial motion
is required. must demonstrate that the device
measurement device into class II
performs as intended.
III. Paperwork Reduction Act of 1995 (iii) Software verification and (special controls). The special controls
This final order establishes special validation must demonstrate that the that will apply to the device are
controls that refer to previously device performs as intended. identified in this order and will be part
approved collections of information (iv) Battery testing must demonstrate of the codified language for the cranial
found in other FDA regulations. These that the device battery performs as motion measurement device’s
collections of information are subject to intended. classification. The Agency is classifying
review by the Office of Management and (3) Clinical performance testing must the device into class II (special controls)
Budget (OMB) under the Paperwork demonstrate the device performs as in order to provide a reasonable
Reduction Act of 1995 (44 U.S.C. 3501– intended and must include an assurance of safety and effectiveness of
3520). The collections of information in evaluation for choking. the device.
part 807, subpart E, regarding premarket (4) Device labeling must address the DATES: This order is effective July 28,
notification submissions have been following: 2017. The classification was applicable
approved under OMB control number (i) Patient labeling must state: on August 1, 2016.
0910–0120, and the collections of (A) The clinical benefit of weight FOR FURTHER INFORMATION CONTACT: Jay
information in 21 CFR part 801 management and/or weight loss as Gupta, Center for Devices and
regarding labeling have been approved assessed by using percent total body Radiological Health, Food and Drug
under OMB control number 0910–0485. weight loss; Administration, 10903 New Hampshire
(B) Treatment must be offered in Ave., Bldg. 66, Rm. 2630, Silver Spring,
List of Subjects in 21 CFR Part 876 combination with a behavioral MD 20993–0002, 301–796–2795,
Medical devices. modification program; jay.gupta@fda.hhs.gov.
(C) Instructions on how to use the
Therefore, under the Federal Food, SUPPLEMENTARY INFORMATION:
device as intended; and
Drug, and Cosmetic Act and under
(D) The use life of the device. I. Background
authority delegated to the Commissioner (ii) Physician labeling must state:
of Food and Drugs, 21 CFR part 876 is (A) The clinical benefit of weight In accordance with section 513(f)(1) of
amended as follows: management and/or weight loss as the Federal Food, Drug, and Cosmetic
assessed by using percent total body Act (the FD&C Act) (21 U.S.C.
PART 876—GASTROENTEROLOGY- 360c(f)(1)), devices that were not in
weight loss;
asabaliauskas on DSKBBXCHB2PROD with RULES
UROLOGY DEVICES (B) Treatment must be offered in commercial distribution before May 28,
combination with a behavioral 1976 (the date of enactment of the
■ 1. The authority citation for part 876
modification program; Medical Device Amendments of 1976),
continues to read as follows:
(C) Instructions on how to use the generally referred to as postamendments
Authority: 21 U.S.C. 351, 360, 360c, 360e, device as intended; and devices, are classified automatically by
360j, 360l, 371. (D) The use life of the device. statute into class III without any FDA
■ 2. Add § 876.5981 to subpart F to read (5) Training must be provided to rulemaking process. These devices
as follows: health professionals that includes remain in class III and require
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Document Created: 2017-07-28 03:10:17
Document Modified: 2017-07-28 03:10:17
| 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 July 28, 2017. The classification was applicable on September 26, 2016. | |
| Contact | Mark Antonino, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G208, Silver Spring, MD, 20993-0002, 240-402-9980, [email protected] | |
| FR Citation | 82 FR 35067 |
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