Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations 27699 

including the limitation imposed on the 

amount to be paid. 

§ 725.716 How should a miner prepare and 

submit requests for reimbursement for 

covered medical expenses and 

transportation costs? 

(a) If a miner has paid bills for a 

medical service or treatment covered 

under § 725.701 and seeks 

reimbursement for those expenses, he or 

she may submit a request for 

reimbursement on Form OWCP–915, 

together with an itemized bill. The 

reimbursement request must be 

accompanied by evidence that the 

provider received payment for the 

service from the miner and a statement 

of the amount paid. Acceptable 

evidence that payment was received 

includes, but is not limited to, a copy 

of the miner’s canceled check (both 

front and back) or a copy of the miner’s 

credit card receipt. 

(b) OWCP may waive the 

requirements of paragraph (a) of this 

section if extensive delays in the filing 

or the adjudication of a claim make it 

unusually difficult for the miner to 

obtain the required information. 

(c) Reimbursements for covered 

medical services paid by a miner 

generally will be no greater than the 

maximum allowable charge for such 

service as determined under 

§§ 725.707–725.711. 

(d) A miner will be only partially 

reimbursed for a covered medical 

service if the amount he or she paid to 

a provider for the service exceeds the 

maximum charge allowable. If this 

happens, OWCP will advise the miner 

of the maximum allowable charge for 

the service in question and of his or her 

responsibility to ask the provider to 

refund to the miner, or credit to the 

miner’s account, the amount he or she 

paid which exceeds the maximum 

allowable charge. 

(e) If the provider does not refund to 

the miner or credit to his or her account 

the amount of money paid in excess of 

the charge allowed by OWCP, the miner 

should submit documentation to OWCP 

of the attempt to obtain such refund or 

credit. OWCP may make reasonable 

reimbursement to the miner after 

reviewing the facts and circumstances of 

the case. 

(f) If a miner has paid transportation 

costs or other incidental expenses 

related to covered medical services 

under this part, the miner may submit 

a request for reimbursement on Form 

OWCP–957 or OWCP–915, together 

with proof of payment. 

§ 725.717 What are the time limitations for 

requesting payment or reimbursement for 

covered medical services or treatments? 

OWCP will pay providers and 

reimburse miners promptly for all bills 

received on an approved form and in a 

timely manner. However, absent good 

cause, no bill will be paid for expenses 

incurred if the bill is submitted more 

than one year beyond the end of the 

calendar year in which the expense was 

incurred or the service or supply was 

provided, or more than one year beyond 

the end of the calendar year in which 

the miner’s eligibility for benefits is 

finally adjudicated, whichever is later. 

A provider may not request 

reimbursement from a miner for a bill 

denied by OWCP due to late submission 

of the bill by the provider. 

§ 725.718 How are disputes concerning 

medical benefits resolved? 

(a) If a dispute develops concerning 

medical services or treatments or their 

payment under this part, OWCP must 

attempt to informally resolve the 

dispute. OWCP may, on its own 

initiative or at the request of the 

responsible operator or its insurance 

carrier, order the claimant to submit to 

an examination by a physician selected 

by OWCP. 

(b) If a dispute cannot be resolved 

informally, OWCP will refer the case to 

the Office of Administrative Law Judges 

for a hearing in accordance with this 

part. Any such hearing concerning 

authorization of medical services or 

treatments must be scheduled at the 

earliest possible time and must take 

precedence over all other hearing 

requests except for other requests under 

this section and as provided by 

§ 727.405 of this subchapter (see 

§ 725.4(d)). During the pendency of such 

adjudication, OWCP may order the 

payment of medical benefits prior to 

final adjudication under the same 

conditions applicable to benefits 

awarded under § 725.522. 

(c) In the development or adjudication 

of a dispute over medical benefits, the 

adjudication officer is authorized to take 

whatever action may be necessary to 

protect the health of a totally disabled 

miner. 

(d) Any interested medical provider 

may, if appropriate, be made a party to 

a dispute under this subpart. 

§ 725.719 What is the objective of 

vocational rehabilitation? 

The objective of vocational 

rehabilitation is the return of a miner 

who is totally disabled by 

pneumoconiosis to gainful employment 

commensurate with such miner’s 

physical impairment. This objective 

may be achieved through a program of 

re-evaluation and redirection of the 

miner’s abilities, or retraining in another 

occupation, and selective job placement 

assistance. 

§ 725.720 How does a miner request 

vocational rehabilitation assistance? 

Each miner who has been determined 

entitled to receive benefits under part C 

of title IV of the Act must be informed 

by OWCP of the availability and 

advisability of vocational rehabilitation 

services. If such miner chooses to avail 

himself or herself of vocational 

rehabilitation, his or her request will be 

processed and referred by OWCP 

vocational rehabilitation advisors 

pursuant to the provisions of §§ 702.501 

through 702.508 of this chapter as is 

appropriate. 

Dated: June 5, 2018. 

Julia K. Hearthway, 

Director, Office of Workers’ Compensation 

Programs. 

[FR Doc. 2018–12418 Filed 6–13–18; 8:45 am] 

BILLING CODE 4510–CR–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2018–N–1928] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

the Brain Trauma Assessment Test 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the brain trauma assessment 

test 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 

brain trauma assessment test’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 June 14, 

2018. The classification was applicable 

on February 14, 2018. 

FOR FURTHER INFORMATION CONTACT: Erin 

Cutts, Center for Devices and 

Radiological Health, Food and Drug 


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27700 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5618, Silver Spring, 

MD 20993–0002, 301–796–6307, 

erin.cutts@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

brain trauma assessment test 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 (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 (21 U.S.C. 

360(k)) and part 807 (21 CFR part 807). 

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. 

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. 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 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 August 28, 2017, Banyan 

Biomarkers, Inc., submitted a request for 

De Novo classification of the Banyan 

BTI. 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 February 14, 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 866.5830. We 

have named the generic type of device 

brain trauma assessment test, and it is 

identified as a device that consists of 

reagents used to detect and measure 

brain injury biomarkers in human 

specimens. The measurements aid in 

the evaluation of patients with 

suspected mild traumatic brain injury in 

conjunction with other clinical 

information to assist in determining the 

need for head imaging per current 

standard of care. 

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—BRAIN TRAUMA ASSESSMENT TEST RISKS AND MITIGATION MEASURES

Identified risks Mitigation measures 

Inaccurate test results that provide false positive or false negative results.General controls and special control (1) (21 CFR 866.5830(b)(1)). 

Failure to correctly interpret test results can lead to false positive or 

false negative results.

General controls and special control (2) (21 CFR 866.5830(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. 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 


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Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations 27701 

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 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 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. 

■ 2. Add § 866.5830 to subpart F to read 

as follows: 

§ 866.5830 Brain trauma assessment test. 

(a) Identification. A brain trauma 

assessment test is a device that consists 

of reagents used to detect and measure 

brain injury biomarkers in human 

specimens. The measurements aid in 

the evaluation of patients with 

suspected mild traumatic brain injury in 

conjunction with other clinical 

information to assist in determining the 

need for head imaging per current 

standard of care. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) The 21 CFR 809.10(b) compliant 

labeling must include detailed 

descriptions of and results from 

performance testing conducted to 

evaluate precision, accuracy, linearity, 

analytical sensitivity, interference, and 

cross-reactivity. This information must 

include the following: 

(i) Performance testing of device 

precision must, at minimum, use one 

unmodified clinical specimen from the 

intended use population with 

concentration of the brain injury 

biomarker(s) near the medical decision 

point. Contrived specimens that have 

been generated from pooling of multiple 

samples or spiking of purified analyte to 

cover the measuring range may be used, 

but the contrived samples must be 

prepared to mimic clinical specimens as 

closely as possible. This testing must 

evaluate repeatability and 

reproducibility using a protocol from an 

FDA-recognized standard. 

(ii) Device performance data must be 

demonstrated through a clinical study 

and must include the following: 

(A) Data demonstrating clinical 

validity including the clinical 

sensitivity and specificity, and positive 

and negative predictive value of the test 

in the intended use population of 

patients with suspected mild traumatic 

brain injury (i.e., Glasgow Coma Score 

(GCS) of 13–15), or equivalent standard 

of care for determination of severity of 

traumatic brain injury (TBI). 

(B) Study must be performed using 

the operators and in settings that are 

representative of the types of operators 

and settings for which the device is 

intended to be used. 

(C) All eligible subjects must meet the 

well-defined study inclusion and 

exclusion criteria that define the 

intended use population. The 

prevalence of diseased or injured 

subjects in the study population must 

reflect the prevalence of the device’s 

intended use population, or 

alternatively, statistical measures must 

be used to account for any bias due to 

enrichment of subpopulations of the 

intended use population. 

(D) All eligible subjects must have 

undergone a head computerized 

tomography (CT) scan or other 

appropriate clinical diagnostic standard 

used to determine the presence of an 

intracranial lesion as part of standard of 

care and must also be evaluated by the 

subject device. All clinical diagnostic 

standards used in the clinical study 

must follow standard clinical practice in 

the United States. 

(E) Relevant demographic variables 

and baseline characteristics including 

medical history and neurological 

history. In addition, head injury 

characteristics, neurological 

assessments, and physical evidence of 

trauma must be provided for each 

subject. This information includes but is 

not limited to the following: Time since 

head injury, time from head injury to CT 

scan, time from head injury to blood 

draw, GCS score or equivalent, 

experience of loss of consciousness, 

presence of confusion, episodes of 

vomiting, post-traumatic amnesia 

characteristics, presence of posttraumatic seizures, drug or alcohol 

intoxication, mechanism of injury, acute 

intracranial lesion type, neurosurgical 

lesion, and cranial fracture. 

(F) Each CT scan or other imaging 

result must be independently evaluated 

in a blinded manner by at least two 

board-certified radiologists to determine 

whether it is positive or negative as 

defined by the presence or absence of 

acute intracranial lesions. This 

independent review must be conducted 

without access to test results of the 

device. Prior to conducting the review, 

the criteria and procedures to be 

followed for scoring the images must be 

established, including the mechanism 

for determining consensus. 

(G) All the clinical samples must be 

tested with the subject device blinded to 

the TBI status and the neurologicallesion-status of the subject. 

(H) Details on how missing values in 

data are handled must be provided. 

(I) For banked clinical samples, 

details on storage conditions and storage 

period must be provided. In addition, a 

specimen stability study must be 

conducted for the duration of storage to 

demonstrate integrity of archived 

clinical samples. The samples evaluated 

in the assay test development must not 

be used to establish the clinical validity 

of the assays. 

(iii) Performance testing of device 

analytical specificity must include the 

most commonly reported concomitant 

medications present in specimens from 

the intended use population. 

Additionally, potential cross-reacting 

endogenous analytes must be evaluated 

at the highest concentration reported in 

specimens from the intended use 

population. 

(iv) Expected/reference values 

generated by testing a statistically 

appropriate number of samples from 

apparently healthy normal individuals. 


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27702 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations 

(2) The 21 CFR 809.10(a) and (b) 

compliant labeling must include the 

following limitations: 

(i) A limiting statement that this 

device is not intended to be used a 

stand-alone device but as an adjunct to 

other clinical information to aid in the 

evaluation of patients who are being 

considered for standard of care 

neuroimaging. 

(ii) A limiting statement that reads ‘‘A 

negative result is generally associated 

with the absence of acute intracranial 

lesions. An appropriate neuroimaging 

method is required for diagnosis of 

acute intracranial lesions.’’ 

(iii) As applicable, a limiting 

statement that reads ‘‘This device is for 

use by laboratory professionals in a 

clinical laboratory setting.’’ 

Dated: June 8, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12760 Filed 6–13–18; 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–2018–N–1862] 

Medical Devices; GastroenterologyUrology Devices; Classification of the 

Endoscopic Electrosurgical Clip 

Cutting System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the endoscopic 

electrosurgical clip cutting 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 

endoscopic electrosurgical clip cutting 

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 June 14, 

2018. The classification was applicable 

on December 22, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Purva Pandya, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G223, Silver Spring, 

MD 20993–0002, 240–402–9979, 

Purva.Pandya@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

endoscopic electrosurgical clip cutting 

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 (21 U.S.C. 

360(k)) and part 807 (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. 

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. 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. 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 lessburdensome 510(k) process, when 

necessary, to market their device. 

II. De Novo Classification 

On April 11, 2016, Ovesco Endoscopy 

AG submitted a request for De Novo 

classification of the remOVE 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. 


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