Unknown. Final amendment; final order

4,281 words·~19 min read·/register/2026/05/12/2026-09335·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2026-05-12.xml --- 91 91 Tuesday, May 12, 2026 Contents Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 25882-25891 2026-09433 2026-09434 2026-09435 2026-09436 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 25891 2026-09330 Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Medicaid and Children's Health Insurance Program, 25892 2026-09329 Children Children and Families Administration PROPOSED RULES Restoring Flexibility to Support Head Start Program Access, 25842-25849 2026-09383 Board Civil Rights Cold Case Records Review Board NOTICES Formal Determination on Records Release, 25850-25856 2026-09336 2026-09367 Coast Guard Coast Guard RULES Safety Zone: Seddon Channel, Tampa, FL, 25786-25787 2026-09375 Safety Zones:

Fireworks Displays in the USCG East District; Philadelphia, PA, 25785-25786 2026-09391 PROPOSED RULES Safety Zone: James River, Richmond, VA, 25840-25842 2026-09377 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration Commodity Futures Commodity Futures Trading Commission PROPOSED RULES Clearing Requirement Determination under Section 2(h) of the Commodity Exchange Act for Interest Rate Swaps to Account for Canadian Dollars and Mexican Pesos Interest Rate Benchmark Transitions, 25812-25840 2026-09428 Education Department Education Department NOTICES Accrediting Agency Currently Undergoing Review for the Purpose of Recognition by the U.S.

Secretary of Education, 25871 2026-09432 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Borrower Defense to Loan Repayment Universal Forms, 25870 2026-09442 Build America, Buy America Act Domestic Sourcing Requirements Waiver—United States Department of Education BABAA Waiver Request Form, 25869 2026-09374 Competition Announcement: Career Pathways Exploration, 25870-25871 2026-09440 Election Election Assistance Commission NOTICES Meetings; Sunshine Act, 25871-25872 2026-09423 Energy Department Energy Department See Federal Energy Regulatory Commission NOTICES Hearings, Meetings, Proceedings, etc.:

Environmental Management Site-Specific Advisory Board, Nevada, 25873 2026-09431 Environmental Management Site-Specific Advisory Board, Paducah, 25872-25873 2026-09430 Environmental Management Site-Specific Advisory Board, Savannah River Site, Postponement, 25872 2026-09376 Environmental Protection Environmental Protection Agency NOTICES Access to Confidential Business Information: Science Applications International Corp., 25881 2026-09370 Federal Aviation Federal Aviation Administration PROPOSED RULES Airworthiness Directives:

Airbus Canada Limited Partnership (Type Certificate Previously Held by C Series Aircraft Limited Partnership (CSALP); Bombardier, Inc.) Airplanes, 25809-25812 2026-09381 Federal Energy Federal Energy Regulatory Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 25873-25875 2026-09332 Application: Northern Illinois Hydropower, LLC; Waiver Period for Water Quality Certification, 25880-25881 2026-09426 Combined Filings, 25875-25878 2026-09378 2026-09379 Effectiveness of Exempt Wholesale Generator Status:

Mayhew Lake Energy Storage, LLC, Crowned Ridge Energy Storage I, LLC, Empire Offshore Wind LLC, et al., 25875 2026-09380 Environmental Assessments; Availability, etc.: Green Mountain Power Corp., 25877 2026-09427 Environmental Impact Statements; Availability, etc.: Lewis Ridge Pumped Storage, LLC, 25878-25880 2026-09425 Federal Motor Federal Motor Carrier Safety Administration NOTICES Exemption Application: Qualification of Drivers; Hearing, 26241-26242 2026-09388 Federal Reserve Federal Reserve System NOTICES Change in Bank Control:

Acquisitions of Shares of a Bank or Bank Holding Company, 25881-25882 2026-09389 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 25882 2026-09390 Food and Drug Food and Drug Administration RULES Medical Devices: Immunology and Microbiology Devices; Classification of the Device to Detect and Identify Microorganism Nucleic Acids and Resistance Markers from Patients with Suspected Orthopedic Infection, 25783-25785 2026-09335 NOTICES 21st Century Cures Act:

Annual Compilation of Notices of Updates from the Susceptibility Test Interpretive Criteria Web Page, 25894-25896 2026-09438 Guidance: Enforcement Priorities for Certain New Tobacco Products Marketed without Premarket Authorization, 25892-25894 2026-09368 Request for Information: Drug Repurposing for Unmet Medical Needs, 25897-25899 2026-09366 Health and Human Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Children and Families Administration See Food and Drug Administration See National Institutes of Health RULES Restoring Flexibility in the Child Care and Development Fund, 25796-25808 2026-09382 Homeland Homeland Security Department See Coast Guard Interior Interior Department See Land Management Bureau See National Park Service PROPOSED RULES Revision of Regulations for Grazing Administration, Exclusive of Alaska, 26852-26885 2026-09387 Internal Revenue Internal Revenue Service NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Notice of Recapture Event for New Markets Credit, 26247-26248 2026-09397 Reporting Requirements for Recipients of Points Paid on Residential Mortgages and Mortgage Interest Statement, 26247 2026-09396 Tip Reporting Alternative Commitment Agreement for Use in the Cosmetology and Barber Industry, 26248 2026-09395 International Trade Adm International Trade Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Parts Tariff Offset Program for Motor Vehicles and Motor Vehicle Parts, 25864-25865 2026-09318 Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Aluminum Foil from the Republic of Turkiye, 25857-25859 2026-09320 Certain Crystalline Silicon Photovoltaic Products from Taiwan, 25862-25864 2026-09322 Steel Concrete Reinforcing Bar from Mexico, 25859-25862 2026-09321 Scope Rulings, 25856-25857 2026-09319 International Trade Com International Trade Commission NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews:

N-Cyclohexylbenzothiazole-2-sulfenamide from China, 25923-25924 2026-09337 Investigations; Determinations, Modifications, and Rulings, etc.: Certain Ink Cartridges and Components Thereof II, 25921-25923 2026-09439 Certain Semiconductor Devices and Products Containing the Same, 25924-25926 2026-09338 Labor Department Labor Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Employment Transition Model, 25926 2026-09373 Land Land Management Bureau RULES Rescission of Conservation and Landscape Health Rule, 25787-25796 2026-09386 PROPOSED RULES Revision of Regulations for Grazing Administration, Exclusive of Alaska, 26852-26885 2026-09387 NOTICES Oil and Gas Lease:

TXNM139423, New Mexico, Proposed Reinstatement, 25901 2026-09441 National Institute National Institutes of Health NOTICES Hearings, Meetings, Proceedings, etc.: Center for Scientific Review, 25899-25900 2026-09323 National Institute of Allergy and Infectious Diseases, 25900-25901 2026-09324 Office of the Secretary, 25901 2026-09325 National Oceanic National Oceanic and Atmospheric Administration NOTICES Comparability Findings: Implementation of Fish and Fish Product Import Provisions of the Marine Mammal Protection Action, 25867-25868 2026-09429 Determination of Overfishing or an Overfished Condition, 25865 2026-09371 Environmental Assessments;

Availability, etc.: Olympic Coast National Marine Sanctuary, Draft Management Plan, 25865-25867 2026-09372 Hearings, Meetings, Proceedings, etc.: Pacific Fishery Management Council, 25868-25869 2026-09316 National Park National Park Service NOTICES Intended Disposition: U.S. Department of the Air Force, Francis E. Warren Air Force Base, Laramie County, WY, 25907 2026-09410 Inventory Completion: California Department of Transportation, Oakland, CA, 25918-25919 2026-09416 California State University, Channel Islands, Camarillo, CA, 25906-25907 2026-09414 Department of the Interior, Bureau of Indian Affairs, Washington, DC, and San Bernardino County Museum, Redlands, CA, 25903-25904 2026-09421 Diablo Valley College, Pleasant Hill, CA, 25912-25913 2026-09420 Field Museum, Chicago, IL, 25910 2026-09412 Kansas State Historical Society, Topeka, KS, 25913-25915 2026-09422 Princeton University, Princeton, NJ, 25909-25910 2026-09405 U.S.

Department of the Air Force, Francis E. Warren Air Force Base, Laramie County, WY, 25911-25912 2026-09409 University of Michigan, Ann Arbor, MI, 25905-25906 2026-09401 University of Northern Colorado, Greeley, CO, 25917-25918 2026-09411 University of Texas at Austin, Texas Archeological Research Laboratory, Austin, TX, 25915-25916 2026-09404 Repatriation of Cultural Items: Benton Museum of Art at Pomona College, Claremont, CA, 25904 2026-09400 California Department of Parks and Recreation, Sacramento, CA, 25909 2026-09398 Chicago Historical Society, Chicago, IL, 25901-25902 2026-09419 Department of the Interior, Bureau of Indian Affairs, Washington, DC, and Arizona State University, School of Human Evolution and Social Change, Tempe, AZ, 25902-25903 2026-09415 J.B Speed Art Museum, Louisville, KY, 25919-25920 2026-09402 Kalamazoo Valley Museum, Kalamazoo, MI, 25911 2026-09413 Los Angeles County Museum of Natural History, Los Angeles, CA, 25920-25921 2026-09399 Museum of Riverside, Riverside, CA, 25904-25905 2026-09417 New York State Museum, Albany, NY, 25917 2026-09403 Robert S.

Peabody Institute of Archaeology, Andover, MA, 25916-25917 2026-09418 University of California, Davis, Davis, CA, 25908-25909, 25919 2026-09406 2026-09407 Yale Peabody Museum, Yale University, New Haven, CT, 25907-25908 2026-09408 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Facility Operating Licenses: Applications and Amendments Involving Proposed No Significant Hazards Considerations, etc., 25927-25936 2026-09369 Regulatory Issue Summary: Combined License Review Performance and Reporting, 25926-25927 2026-09328 Pension Benefit Pension Benefit Guaranty Corporation NOTICES Civil Monetary Penalty Inflation Adjustment, 25936-25937 2026-09334 Personnel Personnel Management Office NOTICES Privacy Act;

Systems of Records, 25937-25938 2026-09339 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Permits; Applications, Issuances, etc.: Hazardous Materials, 26242-26247 2026-09392 2026-09393 2026-09424 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: Military Spouse Day (Proc. 11027), 26887-26890 2026-09505 Victory Day for World War II (Proc. 11028), 26891-26892 2026-09506 Securities Securities and Exchange Commission NOTICES Self-Regulatory Organizations;

Proposed Rule Changes: BOX Exchange LLC, 26802-26850 2026-09365 Cboe BYX Exchange, Inc., 26217-26240 2026-09353 Cboe BZX Exchange, Inc., 26123-26146 2026-09352 Cboe C2 Exchange, Inc., 26194-26217 2026-09354 Cboe EDGA Exchange, Inc., 26008-26031 2026-09351 Cboe EDGX Exchange, Inc., 26054-26077 2026-09350 Cboe Exchange, Inc., 26146-26169 2026-09355 Investors Exchange LLC, 26100-26123, 26252-26300 2026-09340 2026-09349 Miami International Securities Exchange, LLC, 26077-26100, 26352-26400 2026-09342 2026-09344 MIAX Emerald, LLC, 25961-25984, 26602-26650 2026-09343 2026-09360 MIAX PEARL, LLC, 25985-26008, 26031-26054, 26652-26700, 26702-26750 2026-09345 2026-09346 2026-09361 2026-09362 MIAX Sapphire, LLC, 25938-25961, 26752-26800 2026-09347 2026-09363 New York Stock Exchange LLC, 26502-26550 2026-09358 NYSE American LLC, 26452-26500 2026-09357 NYSE Arca, Inc., 26402-26450 2026-09356 NYSE National, Inc., 26302-26350 2026-09341 NYSE Texas, Inc., 26171-26194, 26552-26600 2026-09348 2026-09359 The Depository Trust Co., 26169-26171 2026-09364 Small Business Small Business Administration NOTICES Disaster Declaration:

Texas, 26240-26241 2026-09384 Transportation Department Transportation Department See Federal Aviation Administration See Federal Motor Carrier Safety Administration See Pipeline and Hazardous Materials Safety Administration Treasury Treasury Department See Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Opportunity Zones Nomination Tool, 26249 2026-09437 Separate Parts In This Issue Part II Securities and Exchange Commission, 26252-26300 2026-09340 Part III Securities and Exchange Commission, 26302-26350 2026-09341 Part IV Securities and Exchange Commission, 26352-26400 2026-09342 Part V Securities and Exchange Commission, 26402-26450 2026-09356 Part VI Securities and Exchange Commission, 26452-26500 2026-09357 Part VII Securities and Exchange Commission, 26502-26550 2026-09358 Part VIII Securities and Exchange Commission, 26552-26600 2026-09359 Part IX Securities and Exchange Commission, 26602-26650 2026-09360 Part X Securities and Exchange Commission, 26652-26700 2026-09361 Part XI Securities and Exchange Commission, 26702-26750 2026-09362 Part XII Securities and Exchange Commission, 26752-26800 2026-09363 Part XIII Securities and Exchange Commission, 26802-26850 2026-09365 Part XIV Interior Department, Land Management Bureau, 26852-26885 2026-09387 Interior Department, 26852-26885 2026-09387 Part XV Presidential Documents, 26887-26892 2026-09505 2026-09506 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.

To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription. 91 91 Tuesday, May 12, 2026 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2026-N-4274] Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganism Nucleic Acids and Resistance Markers From Patients With Suspected Orthopedic Infection AGENCY:

Food and Drug Administration, HHS. ACTION: Final amendment; final order. SUMMARY: The Food and Drug Administration

(FDA)is classifying the device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection 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 classification of the device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection. We are taking this action because we have determined that classifying the device into class II 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 May 12, 2026. The classification was applicable on April 29, 2022. FOR FURTHER INFORMATION CONTACT: Bryan Grabias, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3204, Silver Spring, MD 20993-0002, 240-402-9563, *Bryan.Grabias@fda.hhs.gov.* SUPPLEMENTARY INFORMATION: I. Background Upon request, FDA (the Agency or we) has classified the device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection into class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness of the device. 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 into, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (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 device 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 (see also 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 classification 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 premarket notification (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 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 less burdensome 510(k) process, when necessary, to market their device. II. De Novo Classification On October 27, 2020, FDA received BioFire Diagnostics, LLC's request for De Novo classification of the BioFire Joint Infection

(JI)Panel. 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 of the device, 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 section 513(a)(1)(B) of the FD&C Act). 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 April 29, 2022, 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 866.3988. 1 We have named the generic type of device “device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection,” and it is identified as a qualitative in vitro device intended to simultaneously detect and identify microorganism nucleic acids from human clinical specimens collected from patients with suspected orthopedic infection. The device detects specific nucleic acid sequences for microorganism identification as well as markers for antimicrobial resistance. This device is intended to aid in the diagnosis of orthopedic infections when used in conjunction with other clinical signs and symptoms and other laboratory findings. However, the device does not replace traditional methods for culture and susceptibility testing. 1 FDA 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. FDA has identified the risks to health associated with this type of device and the measures required to mitigate these risks in table 1. Table 1—Risks to Health and Mitigation Measures for Devices To Detect and Identify Microorganism Nucleic Acids and Resistance Markers From Patients With Suspected Orthopedic Infection Identified risks to health Mitigation measures Risk of false test results leading to improper patient management Use of certain specimen collection devices identified in special control (1). Certain labeling information identified in special control (2), including limitations, warnings, device descriptions, explanation of procedures, and performance information identified in special controls (3)(iii) and (3)(iv). Certain design verification and validation identified in special control (3), including documentation of certain analytical studies and clinical studies and device descriptions. Failure to correctly interpret test results leading to misdiagnosis and associated risk of false test results Certain labeling information identified in special control (2), including limitations, warnings, device descriptions, explanation of procedures, and performance information identified in special controls (3)(iii) and (3)(iv). Certain design verification and validation identified in special control (3), including documentation of certain analytical studies and clinical studies and device descriptions. Failure to correctly operate the device leading to false test results or incorrect interpretation of test results Use of certain specimen collection devices identified in special control (1). Certain labeling information identified in special control (2), including limitations, warnings, device descriptions, explanation of procedures, and performance information identified in special controls (3)(iii) and (3)(iv). Certain design verification and validation identified in special control (3), including documentation of certain analytical studies and clinical studies and device descriptions. 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 of the device. 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 final order. Under the FD&C Act, submission of a premarket notification under section 510(k) is required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt under section 510(m) of the FD&C Act. At this time FDA has not made this determination for devices to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection. This device is therefore 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 normally 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 management 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 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 § 866.3988 to subpart D to read as follows: § 866.3988 Device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection.

(a)*Identification.* A device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection is a qualitative in vitro device intended to simultaneously detect and identify microorganism nucleic acids from human clinical specimens collected from patients with suspected orthopedic infection. The device detects specific nucleic acid sequences for microorganism identification as well as markers for antimicrobial resistance. This device is intended to aid in the diagnosis of orthopedic infections when used in conjunction with other clinical signs and symptoms and other laboratory findings. However, the device does not replace traditional methods for culture and susceptibility testing.

(b)*Classification.* Class II (special controls). The special controls for this device are:

(1)Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device; alternatively, the sample collection device must be cleared in a premarket submission as a part of this device.

(2)The labeling required under § 809.10(b) of this chapter must include:

(i)An intended use that includes a detailed description of targets the device detects and measures, the results provided to the user, the clinical indications appropriate for test use, and the specific population(s) for which the device is intended.

(ii)Limiting statements, when applicable, indicating:

(A)The device is intended to be used in conjunction with clinical history, signs and symptoms, and results of other diagnostic tests, including culture and antimicrobial susceptibility testing;

(B)Detection of resistance markers cannot be definitively linked to specific microorganisms and that the source of a detected resistance marker may be an organism not detected by the assay; and

(C)Antimicrobial resistance can occur via multiple mechanisms. A not detected result for the antimicrobial resistance gene assays does not indicate antimicrobial susceptibility. Culturing and susceptibility testing of isolates is needed to determine antimicrobial susceptibility.

(iii)A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens.

(iv)Detailed descriptions of the performance characteristics of the device for all claimed specimen types as shown by the analytical and clinical studies required under paragraphs (b)(3)(iii) and (b)(3)(iv) of this section except specimen stability performance characteristics.

(3)Design verification and validation must include:

(i)A detailed device description, including all device parts, control elements incorporated into the test procedure, reagents required but not provided, the principle of device operation and test methodology, and the computational path from collected raw data to reported result ( *e.g.,* how collected raw signals are converted into a reported result).

(ii)A detailed description of the impact of any software, including software applications and hardware-based devices that incorporate software, on the device's functions.

(iii)Detailed documentation of analytical studies, including those demonstrating Limit of Detection, inclusivity, cross-reactivity, microbial interference, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, within lab precision, and reproducibility, as appropriate.

(iv)Detailed documentation and performance results from a clinical study that includes prospective (sequentially collected) samples for each claimed specimen type and, when determined to be appropriate by FDA, additional characterized clinical samples. The study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained using a comparator method that FDA has determined to be appropriate. Detailed documentation must include the clinical study protocol (including a predefined statistical analysis plan), study report, testing results, and results of all statistical analyses. Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2026-09335 Filed 5-11-26; 8:45 am]

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