(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.