50080 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations 

of TREC levels and include samples 

within the measuring range, samples 

above and below the measuring range, 

and samples very near above and below 

the cutoff value. Multiple punches must 

be obtained from each card for 

demonstration of homogeneity of the 

analyte across the dried blood spot. 

Comparability of the test performance 

for each filter paper must be 

demonstrated. Stability and storage of 

TREC DNA on each blood spot card 

must be demonstrated. Results of the 

lot-to-lot study must be summarized 

providing the mean, standard deviation, 

and percentage coefficient of variation 

in a tabular format. Data must be 

calculated for within-run, between-run, 

within-lot, and between-lot. Data 

demonstrating the concordance between 

results across different filter papers 

must be provided. Study acceptance 

criteria must be provided and followed; 

and 

(I) If applicable, a thermocycler 

reproducibility study must be 

performed using thermocyclers from 

three independent thermocyler 

manufacturers. The sample panel must 

consist of specimens with a range of 

TREC levels and must include samples 

within the measuring range, samples 

above and below the measuring range, 

and samples very near above and below 

the cutoff value. The study must be 

done using three filter paper lots and 

conducted over five nonconsecutive 

days. Results of the thermocycler 

reproducibility study must be 

summarized providing the mean, 

standard deviation, and percentage 

coefficient of variance in a tabular 

format. Data must be calculated for the 

within-run, between-run, within-lot, 

between-lot, and between thermocycler 

manufacturer study results. Study 

acceptance criteria must be provided 

and followed. 

(iv) Identification of risk mitigation 

elements used by your device, including 

a description of all additional 

procedures, methods, and practices 

incorporated into the directions for use 

that mitigate risks associated with 

testing. 

(2) Your § 809.10 compliant labeling 

must include: 

(i) A warning statement that reads 

‘‘This test is not intended for diagnostic 

use, preimplantation or prenatal testing, 

or for screening of SCID-like syndromes, 

such as DiGeorge syndrome or Omenn 

syndrome. It is also not intended to 

screen for less acute SCID syndromes, 

such as leaky SCID or variant SCID.’’; 

(ii) A warning statement that reads 

‘‘Test results are intended to be used in 

conjunction with other clinical and 

diagnostic findings, consistent with 

professional standards of practice, 

including confirmation by alternative 

methods and clinical evaluation, as 

appropriate.’’; 

(iii) A description of the performance 

studies listed in paragraph (b)(1)(iii) and 

a summary of the results; and 

(iv) A description of the filter paper 

specifications required for the test. 

Dated: October 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23496 Filed 10–27–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 876 

[Docket No. FDA–2017–N–1609] 

Medical Devices; GastroenterologyUrology 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; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

final order entitled ‘‘Medical Devices; 

Gastroenterology-Urology Devices; 

Classification of the Oral Removable 

Palatal Space Occupying Device for 

Weight Management and/or Weight 

Loss’’ that appeared in the Federal 

Register of July 28, 2017. The final order 

was published with an incorrect 

statement in the preamble about 

whether FDA planned to exempt the 

device from premarket notification 

requirements. This document corrects 

that error. 

DATES: Effective October 30, 2017 

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: In the 

Federal Register of July 28, 2017 (82 FR 

35067), FDA published the final order 

‘‘Medical Devices; GastroenterologyUrology Devices; Classification of the 

Oral Removable Palatal Space 

Occupying Device for Weight 

Management and/or Weight Loss.’’ The 

final order published with an incorrect 

statement in the preamble about 

whether FDA planned to exempt the 

device from premarket notification 

requirements under section 510(k) of the 

FD&C Act. 

In the Federal Register of July 28, 

2017, (82 FR 35067), the following 

correction is made: On page 35069, in 

the first column, the first paragraph is 

corrected as follows: 

‘‘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 has determined that 

premarket notification is necessary to 

provide reasonable assurance of the 

safety and effectiveness of the device. 

Therefore, this device type is not 

exempt from premarket notification 

requirements. Persons who intend to 

market this type of device must submit 

to FDA a premarket notification, prior to 

marketing the device, which contains 

information about the oral removable 

palatal space occupying device for 

weight management and/or weight loss 

they intend to market.’’ 

Dated: October 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23490 Filed 10–27–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 882 

[Docket No. FDA–2017–N–5934] 

Medical Devices; Neurological 

Devices; Classification of the NonElectroencephalogram Physiological 

Signal Based Seizure Monitoring 

System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the nonelectroencephalogram (non-EEG) 

physiological signal based seizure 

monitoring 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 non-EEG 

physiological signal based seizure 

monitoring system’s classification. We 


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