Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations 50077 

(J) Specimen matrix comparison data, 

if more than one specimen type or 

anticoagulant can be tested with the 

device. Samples used for comparison 

must be from well-characterized patient 

samples covering the device measuring 

range. 

(K) Clinical performance must be 

established by comparing data generated 

by testing samples from the indicated 

population and the differential 

diagnosis or non-target disease groups 

with the device to the clinical 

diagnostic standard. 

(1) The diagnosis of NMO and 

NMOSD must be based on clinical 

findings, laboratory tests (e.g., 

serological tests), and radiological tests 

(e.g., magnetic resonance imaging). 

(2) The differential diagnosis or nontarget disease group must include the 

applicable diseases or conditions, 

including but not be limited to the 

following: Multiple sclerosis, stroke, 

Lyme disease, shingles, syphilis, human 

immunodeficiency virus, hepatitis B, 

tuberculosis, Srgen’s syndrome, 

systemic lupus erythematous, systemic 

vasculitis, sarcoidosis, Graves’ disease, 

Hashimoto’s disease, Type I diabetes, 

rheumatoid arthritis, Addison’s disease, 

and myasthenia gravis. 

(3) Diagnosis of diseases or conditions 

for the differential or non-target disease 

groups must be based on established 

diagnostic criteria and clinical 

evaluation. 

(4) For all samples, the diagnostic 

clinical criteria and the demographic 

information must be collected and 

provided. 

(5) The clinical validation results 

must demonstrate clinical sensitivity 

and clinical specificity for the test 

values based on the presence or absence 

of NMO and NMOSD. 

(6) The data must be summarized in 

tabular format comparing the 

interpretation of results to the disease 

status. 

(L) Expected/reference values 

generated by testing an adequate 

number of samples from apparently 

healthy normal individuals. 

(iii) Identification of risk mitigation 

elements used by the device, including 

description of all additional procedures, 

methods, and practices incorporated 

into the directions for use that mitigate 

risks associated with testing. 

(2) The device’s 21 CFR 809.10(b) 

compliant labeling must include 

warnings relevant to the device 

including: 

(i) A warning statement that reads 

‘‘The device is for use by laboratory 

professionals in a clinical laboratory 

setting’’; and 

(ii) A warning statement that reads 

‘‘The device is not to be used as a standalone device but as an adjunct to other 

clinical information. A diagnosis of 

Neuromyelitis Optica (NMO) and 

Neuromyelitis Optica Spectrum 

Disorders (NMOSD) should not be made 

on a single test result. The clinical 

symptoms, results from physical 

examination, laboratory tests (e.g., 

serological tests), and radiological tests 

(e.g. Magnetic Resonance Imaging), 

when appropriate, should always be 

taken into account when considering 

the diagnosis of NMO and NMOSD.’’ 

(3) The device’s 21 CFR 809.10(b) 

compliant labeling must include a 

detailed description of the protocol and 

performance studies performed in 

accordance with paragraph (b)(1)(ii) of 

this section and a summary of the 

results. 

Dated: October 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23489 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 866 

[Docket No. FDA–2017–N–5924] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

the Newborn Screening Test for Severe 

Combined Immunodeficiency Disorder 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the newborn screening test 

for severe combined immunodeficiency 

disorder (SCID) 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 newborn 

screening test for SCID’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 

30, 2017. The classification was 

applicable on December 15, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Caryl Giuliano, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5664, Silver Spring, 

MD 20993–0002, 301–796–2478, 

caryl.giuliano@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

newborn screening test for SCID 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 (the 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 (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 and part 807 (21 

U.S.C. 360(k) and 21 CFR 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. 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. 


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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 (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 October 14, 2014, Wallac Oy, a 

subsidiary of PerkinElmer, Inc., 

submitted a request for De Novo 

classification of the EnLite Neonatal 

TREC Kit. 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 general controls, 

will provide reasonable assurance of the 

safety and effectiveness of the device. 

Therefore, on December 15, 2014, 

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 866.5930. We 

have named the generic type of device 

newborn screening test for SCID, and it 

is identified as a prescription device 

intended to measure T-cell receptor 

excision circle (TREC) DNA obtained 

from dried blood spot specimens on 

filter paper using a polymerase chain 

reaction based test as an aid in 

screening newborns for SCID. 

Presumptive positive results must be 

followed up by diagnostic confirmatory 

testing. This test is not intended for use 

as a diagnostic test, 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. 

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—NEWBORN SCREENING TEST FOR SCID RISKS AND MITIGATION MEASURES

Identified risks Mitigation measures/21 CFR section 

False negative results due to device or user error .................................. Special controls (1) and (2) (21 CFR 866.5930(b)(1) and 21 CFR 

866.5930(b)(2)). 

False positive results due to device or user error ................................... Special controls (1) and (2) (21 CFR 866.5930(b)(1) and 21 CFR 

866.5930(b)(2)). 

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. 

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. 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 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 parts 801 and 

809, regarding labeling, have been 

approved under OMB control number 

0910–0485. 

List of Subjects in 21 CFR Part 866 

Biologics, Laboratories, 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 866 is 

amended as follows: 

PART 866—IMMUNOLOGY AND 

MICROBIOLOGY DEVICES 

■ 1. The authority citation for part 866 

continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 


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■ 2. Add § 866.5930 to subpart F to read 

as follows: 

§ 866.5930 Newborn screening test for 

severe combined immunodeficiency 

disorder (SCID). 

(a) Identification. A newborn 

screening test for SCID is a prescription 

device intended to measure T-cell 

receptor excision circle (TREC) DNA 

obtained from dried blood spot 

specimens on filter paper using a 

polymerase chain reaction based test as 

an aid in screening newborns for SCID. 

Presumptive positive results must be 

followed up by diagnostic confirmatory 

testing. This test is not intended for use 

as a diagnostic test, 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. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Premarket notification 

submissions must include the following 

information: 

(i) The intended use must indicate: 

(A) The test is not intended for 

diagnostic use, or for screening of SCIDlike syndromes, such as DiGeorge 

syndrome or Omenn syndrome; and 

(B) The test is not intended to screen 

for less acute SCID syndromes, such as 

leaky SCID or variant SCID. 

(ii) A detailed description of all 

components in the test that includes: 

(A) A detailed description of the test 

components, all required reagents, 

instrumentation and equipment, 

including illustrations or photographs of 

nonstandard equipment or methods; 

(B) Detailed documentation of the 

device software including, but not 

limited to, standalone software 

applications and hardware-based 

devices that incorporate software; 

(C) Specifications for the filter paper, 

which must be appropriately labeled for 

in vitro diagnostic use, to be used in 

specimen collection and how it will be 

used in specimen collection validation. 

These specifications must include: 

descriptive characteristics of the filter 

paper, instructions on how a lab should 

choose the appropriate filter paper, 

chemical properties of the filter paper, 

interference concerns associated with 

the chemicals in the filter paper, 

absorption properties of the filter paper, 

punch size, absorption capacity, testing 

for homogeneity of punches, diameter of 

the circle for the dried blood spot 

aliquot, absorption time, physical 

composition, and number and size of 

punches to be tested; 

(D) Methodology and protocols for 

detection of T-cell receptor excision 

circles and methods for determination 

of results. The cutoff must be selected 

before conducting clinical and 

analytical studies; 

(E) A description of the result outputs 

along with sample reports. Sample 

reports must include the scale used in 

reporting of results (e.g., TREC copies/ 

mL) and the range of values that will be 

reported out; and 

(F) A description of appropriate 

internal and external controls that are 

recommended or provided. The 

description must identify those control 

elements that are incorporated into the 

testing procedure. 

(iii) Information that demonstrates the 

performance characteristics of the test, 

including: 

(A) Data that demonstrates the clinical 

validity of the device, using well 

characterized prospectively or 

retrospectively obtained clinical 

specimens representative of the 

intended use population. A minimum of 

10 to 15 confirmed positive specimens 

must be obtained from more than 1 site, 

including relevant annotation, and, at 1 

year or beyond, a SCID diagnosis by 

flow cytometry or clinically meaningful 

information regarding the status of the 

subject must be obtained. Additional 

specimens should have been obtained 

that are characterized by other disorders 

that can be found by screening 

specimens that have low or absent TREC 

(e.g., other T-cell lymphopenic 

disorders) to supplement the range of 

results. The clinical validation study 

must have a pre-specified clinical 

decision point (i.e., cutoff to distinguish 

positive and negative results). Results 

must be summarized in tabular format 

comparing interpretation of results to 

the reference method. Point estimates 

together with two-sided 95 percent 

confidence intervals must be provided 

for the positive percent agreement, 

negative percent agreement, and overall 

percent agreement. Data must include 

the retest rate, the false positive rate 

before retest, the final false positive rate, 

and the false negative rate; 

(B) Device reproducibility data 

generated, using a minimum of three 

sites of which at least two must be 

external sites, with two operators at 

each site. Each site must conduct a 

minimum of five runs per operator over 

five nonconsecutive days evaluating a 

minimum of six different relevant TREC 

concentrations that span and are well 

distributed over the measuring range 

and include the clinical cutoff. 

Specimens must include cord blood and 

cord blood diluted with ABO matched 

adult blood specimens. Identical 

specimens from the same sample panel 

must be tested at each site. Each 

specimen must be run in triplicate and 

include controls run in triplicate. 

Results must be reported as the standard 

deviation and percentage coefficient of 

variation for each level tested. Results 

must also be displayed as a 

dichotomous variable around the cutoff. 

Total variation must be partitioned into 

the sum of within-lab and between-lab 

variations with pre-specified acceptance 

criteria and 95 percent confidence 

intervals for all data. Pre-specified 

acceptance criteria must be provided 

and followed; 

(C) Device precision data using 

clinical samples to evaluate the withinlot, between-lot, within-run, between 

run, and total variation. A range of 

TREC levels of the specimen must 

include samples within the measuring 

range, samples above and below the 

measuring range, as well as with 

samples very near above and below the 

cutoff value. At least three replicates of 

each specimen must be tested with 

controls and calibrator(s) according to 

the device instructions for use. The 

precision study must use well 

characterized samples using different 

lots, instruments, and operators. Results 

must be summarized in tabular format. 

Pre-specified acceptance criteria must 

be provided and followed; 

(D) Linearity of the test must be 

demonstrated using a dilution panel 

from clinical samples. The range of 

dilution samples must include samples 

within the measuring range, samples 

above and below the measuring range, 

as well as with samples very near above 

and below the cutoff value. Results of 

the regression analysis must be 

summarized in tabular format and fitted 

into a linear regression model with the 

individual measurement results against 

the dilution factors. Pre-specified 

acceptance criteria must be provided 

and followed; 

(E) Device analytic sensitivity data, 

including limit of blank, limit of 

detection, and limit of quantification; 

(F) Device specificity data, including 

interference, carryover, crosscontamination, and in silico analysis of 

potential off-target genomic sequences; 

(G) Device stability data, including 

real-time stability of samples under 

various storage times, temperatures, and 

freeze-thaw conditions. A separate 

shipping stability study must be 

performed; 

(H) Lot-to-lot reproducibility study of 

each filter paper that will be validated 

with the test. The lot-to-lot study must 

include a minimum of three lots of each 

blood spot card that will be validated 

with the test and be conducted over five 

nonconsecutive days. The sample panel 

must consist of specimens with a range 


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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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