(a) Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

(b) Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 64 FR 1125, Jan. 8, 1999]

(a) Identification. A fludeoxyglucose F18-guided radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator. The device is intended for use with approved fludeoxyglucose F18. The emission computed tomography detection system acquires images of positron-emitting fludeoxyglucose F18 for the purpose of guiding the delivery of megavoltage X-rays for oncologic treatment with radiation therapy using an FDA-cleared, -authorized, or -approved linear accelerator.

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

(1) An analysis must be provided of any effects on safety or effectiveness based on differences that exist in the use (i.e., concentration, rate of administration, route of administration; region, organ, or system of the body; or patient population) of fludeoxyglucose F18 with the device compared to the current approved drug labeling; and adequate justification, including support from clinical performance testing and labeling, must be provided that the differences do not adversely affect the safety and effectiveness of fludeoxyglucose F18 when used with the device.

(2) Design verification and validation activities must include monitoring of changes to the labeling and formulation of fludeoxyglucose F18, and addressing such changes so that they do not adversely affect the safety and effectiveness of the device and fludeoxyglucose F18 when used with the device.

(3) Clinical performance testing must demonstrate that the system performs as intended under anticipated conditions of use, including demonstrating: adequate reader performance for distinguishing patients with eligible versus ineligible radiopharmaceutical biodistribution on imaging; reproducibility across fractions; and sufficient signal strength to meet system sensitivity requirements. Clinical performance testing under anticipated conditions of use must evaluate: dose ranging for identification of lowest safe and adequate dose; and all adverse events.

(4) Non-clinical performance testing under anticipated conditions of use must demonstrate:

(i) Compatibility of the linear accelerator and the tomography scanner;

(ii) Adequate positron emission tomography (PET) imaging performance for patient selection in comparison with a legally marketed diagnostic scanner's output;

(iii) Adequacy of the chosen imaging metrics for inter- and intra-fractional treatment delivery; and

(iv) Dosimetric concurrence between delivered dose distributions and treatment plan, including comparison of delivery isolating difference between guidance on and off conditions.

(5) Performance testing must demonstrate the electrical safety and electromagnetic compatibility of any electrical components.

(6) Software verification, validation, and hazard analysis must be performed for any software components of the device. Software documentation must include a detailed description of the dose delivery tracking algorithms, including the dose calculation methods, treatment boundaries, treatment delivery fluence calculation methods, system latency for moving targets, interface for post-treatment review, limitations of the algorithm, and accompanying verification and validation testing to ensure device and algorithm functionality as informed by the software requirements and hazard analysis.

(7) A training program must be included to ensure users can correctly interpret images to determine patient eligibility.

(8) The labeling must include the following:

(i) A detailed description of the patient population included in clinical testing specifying age, primary cancer type, cancer stage, and target volume locations and sizes;

(ii) A dedicated imaging agent section which includes a description of the use of fludeoxyglucose F18 with the device and a statement in the indications for use informing users where full prescribing information is available for fludeoxyglucose F18 in the current approved drug labeling and in the device labeling;

(iii) Detailed instructions for use of fludeoxyglucose F18 with the device to guide radiation therapy, including: uptake time needed, time window to deliver treatment, physician review of pre-delivery safety checks, image interpretation, tissue targeted for fludeoxyglucose F18 uptake, pre-treatment image criteria to determine patient eligibility, and other differences compared to the current approved fludeoxyglucose F18 drug labeling;

(iv) A detailed summary of the performance testing required under paragraphs (b)(3) and (b)(4) of this section, including test methods, dataset characteristics, and results;

(v) A detailed description of the user workflow; and

(vi) An instruction for users to plan for an alternative treatment if pre-treatment evaluation fails.

[91 FR 50710, Aug. 6, 2026]

(a) Identification. A medical neutron radiation therapy system is a device intended to generate high-energy neutrons for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment support, treatment planning computer programs, component parts, and accessories.

(b) Classification. Class II.

(a) Identification. A manual radionuclide applicator system is a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 65 FR 2323, Jan. 14, 2000]

(a) Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.

(b) Classification. Class II.

(a) Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.

(b) Classification. Class II.

(a) Identification. A rectal balloon for prostate immobilization is a single use, inflatable, non-powered positioning device placed in the rectum to immobilize the prostate in patients undergoing radiation therapy. The device is intended to be used during all the phases of radiation therapy, including treatment planning, image verification, and radiotherapy delivery.

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

(1) The premarket notification submission must include methodology and results of the following non-clinical and clinical performance testing:

(i) Biocompatibility testing of the final finished device;

(ii) If provided sterile, sterilization validation;

(iii) If not provided sterile, bioburden testing of the final finished device;

(iv) Shelf life and expiration date validation; and

(v) Performance testing including but not limited to:

(A) Venting mechanism (if device has a vent mechanism);

(B) Safety mechanism(s) to prevent advancement beyond its intended safe placement; and

(C) Structural integrity testing (e.g., tensile strength, balloon leakage and burst strength).

(2) Labeling that includes:

(i) Appropriate warnings and contraindications, including, but not limited to the following statements:

(A) “Do not transport the patient with the rectal balloon inserted. The balloon should be removed prior to transport.”;

(B) “Failure to perform the standard imaging position verification protocol may cause the device to not perform as intended.”;

(C) “Reduce the rectal balloon fill volume if the patient experiences discomfort due to the rectal balloon inflation.”; and

(D) “Do not apply excessive pressure/force on the shaft or tubing of the rectal balloon.”

(ii) Adequate instructions for use on the proper insertion procedure, positioning, and inflation of the rectal balloon;

(iii) Whether the device is sterile or non-sterile; and

(iv) An expiration date.

[82 FR 61171, Dec. 27, 2017]

(a) Identification. An absorbable perirectal spacer is composed of biodegradable material that temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate cancer with the intent to reduce the radiation dose delivered to the anterior rectum. The absorbable spacer maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

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

(1) The premarket notification submission must include methodology and results of the following non-clinical and clinical performance testing. For all clinical investigations used to support premarket notification submissions for this type of device, line listings of the study data must be provided.

(i) Performance bench testing must demonstrate appropriate perirectal space creation and maintenance for the duration of prostate radiotherapy.

(ii) Performance bench testing must demonstrate that therapeutic radiation levels do not alter the performance of the device.

(iii) Performance in vivo testing must demonstrate appropriate deployment of spacer as indicated in the accompanying labeling, and demonstrate appropriate expansion and absorption characteristics in a clinically relevant environment.

(iv) Clinical study must demonstrate appropriate spacer stability and lack of migration for the entire course of radiotherapy, complete absorption, and lack of long term toxicity.

(v) Sterility testing must demonstrate the sterility of the device and the effects of the sterilization process on the physical characteristics of the spacer.

(vi) Shelf-life testing must demonstrate the stability of the physical characteristics of the spacer throughout the shelf-life as indicated in the accompanying labeling.

(vii) The device must be demonstrated to be biocompatible.

(2) The risk management activities performed as part of the manufacturer's § 820.10(c) of this chapter design and development activities must document an appropriate end user initial training program which will be offered as part of efforts to mitigate the risk of failure to correctly operate the device, including, but not limited to, documentation of an appropriate end user initial training program on the proper spacer deployment technique.

(3) The device labeling must include the following:

(i) A detailed summary of reported or observed complications related to the use of the device;

(ii) Appropriate warnings;

(iii) Detailed instructions for system preparations and detailed implant procedure instructions; and

(iv) An expiration date that is supported by performance data as specified in paragraph (b)(1)(vi) of this section.

[83 FR 601, Jan. 5, 2018, as amended at 90 FR 55996, Dec. 4, 2025]

(a) Identification. A phase-changing fiducial marker for radiation therapy is a single-use, sterile liquid material that changes phase in situ when injected in tissue for the purposes of aiding radiation therapy treatment. The device is intended to be visualized using one or more radiologic imaging modalities.

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

(1) Clinical performance data under anticipated conditions of use must evaluate:

(i) Risk of marker migration in tissue during the course of radiation therapy through post-treatment follow-up;

(ii) The ability to visualize the marker to allow for adequate localization during the course of radiation therapy through post-treatment follow-up;

(iii) Risk of device interference with tumor response assessment post-treatment; and

(iv) All adverse events.

(2) Animal performance data under anticipated conditions of use must evaluate device toxicity and the risk of marker migration.

(3) Non-clinical performance data under anticipated conditions of use must evaluate:

(i) Maintenance of physical form throughout the course of therapy and post-treatment follow-up;

(ii) Device visibility on one or more radiologic imaging modalities; and

(iii) Device interference with radiation dose delivery.

(4) Performance testing must demonstrate the patient-contacting components of the device are biocompatible.

(5) Performance testing must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.

(6) Performance testing must demonstrate device sterility and non-pyrogenicity.

(7) Usability testing must demonstrate that the device can be positioned as indicated based solely on reading the directions for use.

(8) The labeling must include:

(i) A detailed description of the device including materials and composition, chemical and physical properties, a description of the mechanism of the change of phase, and timeframe for achieving final state;

(ii) Summary of all reported device-related adverse events from clinical testing;

(iii) Information describing the injection procedure, including any use of image guidance, and the range of compatible injection needle gauges; and

(iv) A shelf life.

[91 FR 47790, July 29, 2026]

(a) Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.

(b) Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019]

(a) Identification. A radionuclide teletherapy source is a device consisting of a radionuclide enclosed in a sealed container. The device is intended for radiation therapy, with the radiation source located at a distance from the patient's body.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 59 FR 63015, Dec. 7, 1994; 66 FR 38819, July 25, 2001]

(a) Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.

(b) Classification. Class II.

(a) Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.

(b) Classification. Class II.

(a) Identification. A light beam patient position indicator is a device that projects a beam of light (incoherent light or laser) to determine the alignment of the patient with a radiation beam. The beam of light is intended to be used during radiologic procedures to ensure proper positioning of the patient and to monitor alignment of the radiation beam with the patient's anatomy.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, 2001]

(a) Identification. A radiation therapy marking device is a powered device that transdermally delivers a permanent or temporary colorant to the skin for the purpose of placing marks to guide radiation therapy. This classification does not include devices with reusable or reprocessed needles or devices intended for diagnostic, therapeutic, or aesthetic use or to deliver other products for these uses.

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

(1) Design verification and validation must include:

(i) Documentation of performance data from studies that demonstrate:

(A) The indicated colorant is compatible with the device and its method of delivery;

(B) The device can reproducibly deliver the indicated colorant with the specifications described; and

(C) The length of time that compatible colorants remain visible on the skin following device application.

(ii) Documentation of performance data from studies that demonstrate:

(A) Accuracy and reproducibility of needle penetration depth;

(B) Device protection from cross-contamination, including fluid ingress protection;

(C) Adequacy of the cleaning and disinfection instructions to ensure that the reusable components of the device can be cleaned and disinfected; and

(D) The sterility of all patient-contacting components (e.g., safety needle).

(iii) Documentation of performance data from studies that demonstrate electrical safety and electromagnetic compatibility of all electrical components of the device.

(iv) Documentation of performance data from studies that demonstrate continued sterility, package integrity, and device functionality over the intended shelf life.

(v) Documentation of software verification, validation, and hazard analysis.

(2) The labeling required under § 801.109(c) of this chapter must include:

(i) An explanation of the device and the mechanism of operation;

(ii) Validated methods and instructions for reprocessing of any reusable components;

(iii) Disposal instructions; and

(iv) A shelf life for all sterile components.

[91 FR 23167, Apr. 30, 2026]

(a) Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

(b) Classification. Class II.

(a) Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

(b) Classification. Class II.

(a) Identification. A therapeutic x-ray tube housing assembly is an x-ray generating tube encased in a radiation-shielded housing intended for use in radiation therapy. This generic type of device may include high-voltage and filament transformers or other appropriate components when contained in radiation-shielded housing.

(b) Classification. Class II.