72982 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Rules and Regulations 

‘‘Sacramento Mather Airport, CA.’’ The 

geographic coordinates of the airport are 

updated to match the FAA’s database. 

Lastly, Sacramento Mather Airport has 

part-time Class D airspace but does not 

include a part-time statement within the 

legal description. Part-time verbiage is 

added to the legal description to 

properly describe the airspace. 

Regulatory Notices and Analyses 

The FAA has determined that this 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current. It, therefore: (1) is not a 

‘‘significant regulatory action’’ under 

Executive Order 12866; (2) is not a 

‘‘significant rule’’ under DOT 

Regulatory Policies and Procedures (44 

FR 11034; February 26, 1979); and (3) 

does not warrant preparation of a 

regulatory evaluation as the anticipated 

impact is so minimal. Since this is a 

routine matter that only affects air traffic 

procedures and air navigation, it is 

certified that this rule, when 

promulgated, does not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

Environmental Review 

The FAA has determined that this 

action qualifies for categorical exclusion 

under the National Environmental 

Policy Act in accordance with FAA 

Order 1050.1F, ‘‘Environmental 

Impacts: Policies and Procedures,’’ 

paragraph 5–6.5.a. This airspace action 

is not expected to cause any potentially 

significant environmental impacts, and 

no extraordinary circumstances exist 

that warrant preparation of an 

environmental assessment. 

Lists of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

The Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

amends 14 CFR part 71 as follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

■ 1. The authority citation for 14 CFR 

part 71 continues to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g), 40103, 

40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 

1959–1963 Comp., p.389. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of FAA Order JO 7400.11H, 

Airspace Designations and Reporting 

Points, dated August 11, 2023, and 

effective September 15, 2023, is 

amended as follows: 

Paragraph 5000 Class D Airspace 

* * * * * 

AWP CA D Sacramento, CA [Amended] 

Sacramento Mather Airport, CA 

(Lat. 38°33′19′′ N, long 121°17′50′′ W) 

That airspace extending upward from the 

surface to and including 2,600 feet MSL 

within a 4.5-mile radius of the airport, and 

within 1.9 miles each side of the 061° bearing 

from the airport, extending from the 4.5-mile 

radius to 6.3 miles northeast of the airport. 

This Class D airspace area is effective during 

the specific dates and times established in 

advance by a Notice to Air Missions. The 

effective date and time will thereafter be 

continuously published in the Chart 

Supplement. 

* * * * * 

Paragraph 6005 Class E Airspace Areas 

Extending Upward From 700 Feet or More 

Above the Surface of the Earth. 

* * * * * 

AWP CA E5 Sacramento, CA [New] 

Sacramento Mather Airport, CA 

(Lat. 38°33′19′′ N, long. 121°17′50′′ W) 

That airspace extending upward from 700 

feet above the surface within a 6.8-mile 

radius of the airport from the 075° bearing 

clockwise to the 210° bearing, and within 2.8 

miles northwest and 2.4 miles southeast of 

the 054° bearing extending from the airport 

to 12.7 miles northeast, and within 6 miles 

northwest and 9 miles southeast of the 054° 

bearing extending from 12.7 miles northeast 

of the airport to 37 miles northeast, and 

within 2.8 miles either side of the 234° 

bearing extending from the airport to 10.9 

miles southwest. 

* * * * * 

Issued in Des Moines, Washington, on 

September 3, 2024. 

B.G. Chew, 

Group Manager, Operations Support Group, 

Western Service Center. 

[FR Doc. 2024–20198 Filed 9–6–24; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 862 

[Docket No. FDA–2024–N–4086] 

Medical Devices; Clinical Chemistry 

and Clinical Toxicology Devices; 

Classification of the Blood Collection 

Device for Cell-Free Nucleic Acids 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

classifying the blood collection device 

for cell-free nucleic acids 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 blood 

collection device for cell-free nucleic 

acids’ 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 September 

9, 2024. The classification was 

applicable on August 7, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Lindsey Coe, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3556, Silver Spring, 

MD 20993–0002, 240–402–5267, 

Lindsey.Coe@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

blood collection device for cell-free 

nucleic acids as class II (special 

controls), which we have determined 

will provide a reasonable assurance of 

safety and effectiveness. 

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 (see 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 

device by means of the procedures for 

premarket notification under section 


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Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Rules and Regulations 72983 

1FDA notes that the ‘‘ACTION’’ caption for this 

final order is styled as ‘‘Final amendment; final 

order,’’ rather than ‘‘Final order.’’ Beginning in 

December 2019, this editorial change was made to 

indicate that the document ‘‘amends’’ the Code of 

Federal Regulations. The change was made in 

accordance with the Office of Federal Register’s 

(OFR) interpretations of the Federal Register Act (44 

U.S.C. chapter 15), its implementing regulations (1 

CFR 5.9 and parts 21 and 22), and the Document 

Drafting Handbook. 

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 (see also 21 CFR part 860, 

subpart D (21 CFR part 860, subpart D)). 

Section 207 of the Food and Drug 

Administration Modernization Act of 

1997 (Pub. L. 105–115) established the 

first procedure for De Novo 

classification. Section 607 of the Food 

and Drug Administration Safety and 

Innovation Act (Pub. L. 112–144) 

modified the De Novo application 

process by adding a second procedure. 

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 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. 

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 section 513(f)(2)(B)(i) of the 

FD&C Act). As a result, other device 

sponsors do not have to submit a De 

Novo request or premarket approval 

application to market a substantially 

equivalent device (see section 513(i) of 

the FD&C Act, defining ‘‘substantial 

equivalence’’). Instead, sponsors can use 

the 510(k) process, when necessary, to 

market their device. 

II. De Novo Classification 

On January 10, 2020, FDA received 

Streck, Inc.’s request for De Novo 

classification of the Cell-Free DNA BCT. 

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 August 7, 2020, FDA 

issued an order to the requester 

classifying the device into class II. In 

this final order, FDA is codifying the 

classification of the device by adding 21 

CFR 862.1676.1 We have named the 

generic type of device blood collection 

device for cell-free nucleic acids, and it 

is identified as intended for medical 

purposes to collect, store, transport, and 

handle blood specimens and to stabilize 

and isolate cell-free nucleic acid 

components prior to further testing. 

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—BLOOD COLLECTION DEVICE

FOR CELL-FREE NUCLEIC ACIDS

RISKS AND MITIGATION MEASURES

Identified risks to health Mitigation measures 

Blood pathogen exposure/Injury.Certain design 

verification and validation. 

Failure to collect and 

transport sample.

Certain design 

verification and validation. 

Insufficient sample quantity and quality.Certain design 

verification and validation. 

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 

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. 3501–3521). The 

collections of information in part 860, 

subpart D, regarding De Novo 

classification 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; the 

collections of information in 21 CFR 

part 820, regarding quality system 

regulation, have been approved under 

OMB control number 0910–0073; 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 862 

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 862 is 

amended as follows: 

PART 862—CLINICAL CHEMISTRY 

AND CLINICAL TOXICOLOGY 

DEVICES 

■ 1. The authority citation for part 862 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 862.1676 to subpart B to read 

as follows: 


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72984 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Rules and Regulations 

§ 862.1676 Blood collection device for cellfree nucleic acids. 

(a) Identification. A blood collection 

device for cell-free nucleic acids is a 

device intended for medical purposes to 

collect, store, transport, and handle 

blood specimens and to stabilize and 

isolate cell-free nucleic acid 

components prior to further testing. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Design verification and validation 

documentation must include 

appropriate design inputs and design 

outputs that are essential for the proper 

functioning of the device for its 

intended use, including all of its 

indications for use, and must include 

the following: 

(i) Documentation demonstrating that 

appropriate, as determined by FDA, 

measures are in place (e.g., validated 

device design features and 

specifications) to ensure that users of 

blood collection device for cell-free 

nucleic acids devices are not exposed to 

undue risk of bloodborne pathogen 

exposure and operator injury during use 

of the device, including blood 

collection, transportation, and 

centrifugation processes. 

(ii) Documentation demonstrating that 

appropriate, as determined by FDA, 

measures are in place (e.g., validated 

device design features and 

specifications) to ensure that the device 

reproducibly and reliably collects, 

transports, stabilizes, and isolates cellfree nucleic acids of sufficient yield and 

quality suitable for downstream 

applications as appropriate for its 

intended use. At a minimum, these 

measures must include: 

(A) Data demonstrating that blood 

samples collected in the device have 

reproducible cell-free nucleic acid 

yields that are suitable, as determined 

by FDA, for downstream testing as 

appropriate for the intended use, 

including estimates of within-lot, 

within-device, and lot-to-lot variability; 

(B) Data demonstrating that cell-free 

nucleic acid yields isolated from blood 

specimens collected into the device do 

not add clinically significant bias to test 

results obtained using the downstream 

application(s) described in the intended 

use. For devices indicated for use with 

multiple downstream applications, data 

demonstrating acceptable performance 

for each type of claimed use or, 

alternatively, an appropriate, as 

determined by FDA, clinical 

justification for why such data are not 

needed; 

(C) Data demonstrating that the device 

appropriately stabilizes cell-free nucleic 

acids after sample collection, during 

storage, and during transport over the 

claimed shelf life of the device; 

(D) Data demonstrating that samples 

collected in the device have minimal 

levels of contamination with other types 

of nucleic acids present in cells or 

cellular components, and that these 

levels of contamination do not interfere 

with downstream testing; 

(E) Data from analytical or clinical 

studies that demonstrate that, when 

used as intended, the device 

consistently draws a blood sample 

volume that is within the indicated fill 

range; 

(F) Data from analytical or clinical 

studies that demonstrate that, when 

used as intended, cell-free nucleic acid 

yield, stability, and quality are not 

significantly impacted by interference 

due to other parts of the device (such as 

reduced or excess active ingredient) or 

specimen collection and processing 

procedures (such as hemolysis, 

centrifugation, or mixing of blood with 

anticoagulant or additives); and 

(G) Data from analytical studies that 

demonstrate that the device is suitable 

for its intended use across all storage 

and sample handling conditions 

described in the device labeling, 

including device shelf life and shipping 

conditions (e.g., temperature, humidity, 

duration). 

(iii) A protocol, reviewed and 

determined acceptable by FDA, that 

specifies the verification and validation 

activities that will be performed for 

anticipated device modifications to 

reevaluate performance claims or 

performance specifications. This 

protocol must include a process for 

assessing whether a modification to 

technology, engineering, performance, 

materials, specifications, or indications 

for use, or any combination thereof, 

could significantly affect the safety or 

effectiveness of the device. The protocol 

must include assessment metrics, 

acceptance criteria, and analytical 

methods for the performance testing of 

changes. 

Dated: September 4, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–20254 Filed 9–6–24; 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–2024–N–4059] 

Medical Devices; GastroenterologyUrology Devices; Classification of the 

Endoscopic Pancreatic Debridement 

Device 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the endoscopic pancreatic 

debridement device 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 

pancreatic debridement device’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. 

DATES: This order is effective September 

9, 2024. The classification was 

applicable on December 23, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Thelma Valdes, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2610, Silver Spring, 

MD 20993–0002, 301–796–9621, 

Thelma.Valdes@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

endoscopic pancreatic debridement 

device as class II (special controls), 

which we have determined will provide 

a reasonable assurance of safety and 

effectiveness. 

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 


ddrumheller on DSK120RN23PROD with RULES1