ML23052A201
| ML23052A201 | |
| Person / Time | |
|---|---|
| Issue date: | 07/19/2023 |
| From: | NRC/NMSS/DMSST |
| To: | |
| Shared Package | |
| ML23052A197 | List: |
| References | |
| Download: ML23052A201 (6) | |
Text
10 CFR 35 Placement Evaluation for CivaDermTM 1
Section Description Applicable Rule Notes Subpart A - General Information 35.1 Purpose and scope Yes No N/A 35.2 Definitions Yes No N/A 35.5 Maintenance of records Yes No N/A 35.6 Provisions for the protection of human research subjects Yes No N/A 35.7 FDA, other Federal, and State requirements Yes No N/A 35.8 Information collection requirements: OMB approval Yes No N/A 35.10 Implementation Yes No N/A 35.11 License required Yes No N/A 35.12 Application for license, amendment, or renewal Yes No N/A 35.13 License amendments Yes No N/A 35.14 Notifications Yes No N/A 35.15 Exemptions regarding Type A specific licenses of broad scope Yes No N/A 35.18 License issuance Yes No N/A 35.19 Specific exemptions Yes No N/A Subpart B - General Administrative Requirements 35.24 Authority and responsibilities for the radiation protection program Yes No N/A 35.26 Radiation protection program changes Yes No N/A 35.27 Supervision Yes No N/A 35.40 Written directives (WDs)
Yes No N/A Requirements in 10 CFR 35.40(b)(7) can be used for CivaDerm. As implant is defined as to insert or fix, the term implantation in this regulation is the process of fixing the sources to the skin.
35.41 Procedures for administrations requiring a WD Yes No N/A 35.49 Suppliers for sealed sources or devices for medical use Yes No N/A
10 CFR 35 Placement Evaluation for CivaDermTM 2
Section Description Applicable Rule Notes 35.50 Training for Radiation Safety Officer (RSO) and Associate RSO Yes No N/A 35.51 Training for an authorized medical physicist (AMP)
Yes No N/A 35.55 Training for an authorized nuclear pharmacist (ANP)
Yes No N/A 35.57 Training for experienced RSO, teletherapy or medical physicist, AMP, authorized user (AU), nuclear pharmacist, and ANP Yes No N/A 35.59 Recentness of training Yes No N/A Subpart C - General Technical Requirements 35.60 Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material Yes No N/A 35.61 Calibration of survey instruments Yes No N/A 35.63 Determination of dosages of unsealed byproduct material for medical use Yes No N/A 35.65 Authorization for calibration, transmission, and reference sources Yes No N/A 35.67 Requirements for possession of sealed sources and brachytherapy sources Yes No N/A 35.69 Labeling of vials and syringes Yes No N/A 35.70 Surveys of ambient radiation exposure rate Yes No N/A 35.75 Release of individuals containing unsealed byproduct material or implants containing byproduct material Yes No N/A Implant is defined as inserted or affixed. As CivaDerm is medically affixed, it meets the definition of an implant. However, additional guidance is needed in situations which source is dislodged.
35.80 Provision of mobile medical service Yes No N/A 35.92 Decay-in-storage Yes No N/A Subpart D - Unsealed Byproduct Material - Written Directive Not Required 35.100 Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a WD is not required Yes No N/A 35.190 Training for uptake dilution, and excretion studies Yes No N/A
10 CFR 35 Placement Evaluation for CivaDermTM 3
Section Description Applicable Rule Notes 35.200 Use of unsealed byproduct material for imaging and localization studies for which a WD is not required Yes No N/A 35.204 Permissible Mo-99, Sr-82, Sr-85 concentrations Yes No N/A 35.290 Training for imaging and localization studies Yes No N/A Subpart E - Unsealed Byproduct Material - WD Required 35.300 Use of unsealed byproduct material for which a WD is required Yes No N/A 35.310 Safety instruction Yes No N/A 35.315 Safety precautions Yes No N/A 35.390 Training for use of unsealed byproduct material for which a WD is required Yes No N/A 35.392 Training for the oral administration of NaI I-131 requiring a WD in quantities <= 1.22 GBq (33 mCi)
Yes No N/A 35.394 Training for the oral administration of NaI I-131 requiring a WD in quantities > 1.22 GBq (33 mCi)
Yes No N/A 35.396 Training for the parenteral administration of unsealed byproduct material requiring a WD Yes No N/A Subpart F - Manual Brachytherapy 35.400 Use of sources for manual brachytherapy Yes No N/A 35.404 Surveys after source implant and removal Yes No N/A As licensees can still make this survey after the final source is removed, this regulation can be met and there is no need for additional conditions.
35.406 Brachytherapy sources accountability Yes No N/A Like other outpatient temporary brachytherapy uses, such as eye plaques, licensees can maintain brachytherapy source accountability.
However, additional guidance for outpatient use is needed.
35.410 Safety instruction Yes No N/A 35.415 Safety precautions Yes No N/A 35.432 Calibration measurements of brachytherapy sources Yes No N/A 35.433 Sr-90 sources for ophthalmic treatments Yes No N/A
10 CFR 35 Placement Evaluation for CivaDermTM 4
Section Description Applicable Rule Notes 35.457 Therapy-related computer systems Yes No N/A 35.490 Training for use of manual brachytherapy sources Yes No N/A 35.491 Training for ophthalmic use of Sr-90 Yes No N/A Subpart G - Sealed Sources for Diagnosis 35.500 Use of sealed sources and medical devices for diagnosis Yes No N/A 35.590 Training for use of sealed sources and medical devices for diagnosis Yes No N/A Subpart H - Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery (GSR) Units 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or GSR unit Yes No N/A 35.604 Surveys of patients and human research subjects treated with a remote afterloader unit Yes No N/A 35.605 Installation, maintenance, adjustment, and repair Yes No N/A 35.610 Safety procedures and instructions for remote afterloader units, teletherapy units, and GSR units Yes No N/A 35.615 Safety precautions for remote afterloader units, teletherapy units, and GSR units Yes No N/A 35.630 Dosimetry equipment Yes No N/A 35.632 Full calibration measurements on teletherapy units Yes No N/A 35.633 Full calibration measurements on remote afterloader units Yes No N/A 35.635 Full calibration measurements on GSR units Yes No N/A 35.642 Periodic spot-checks for teletherapy units Yes No N/A 35.643 Periodic spot-checks for remote afterloader units Yes No N/A 35.645 Periodic spot-checks for GSR units Yes No N/A 35.647 Additional technical requirements for mobile remote afterloader units Yes No N/A 35.652 Radiation surveys Yes No N/A 35.655 Full-inspection servicing for teletherapy and GSR units Yes No N/A 35.657 Therapy-related computer systems Yes No N/A
10 CFR 35 Placement Evaluation for CivaDermTM 5
Section Description Applicable Rule Notes 35.690 Training for use of remote afterloader units, teletherapy units, and GSR units Yes No N/A Subpart L - Records 35.2024 Records of authority and responsibilities for radiation protection programs Yes No N/A 35.2026 Records of radiation protection program changes Yes No N/A 35.2040 Records of WDs Yes No N/A 35.2041 Records for procedure for administrations requiring a WD Yes No N/A 35.2060 Records of calibrations of instruments used to measure the activity of unsealed byproduct materials Yes No N/A 35.2061 Records of radiation survey instrument calibrations Yes No N/A 35.2063 Records of dosages of unsealed byproduct material for medical use Yes No N/A 35.2067 Records of leaks tests and inventory of sealed sources and brachytherapy sources Yes No N/A 35.2070 Records of surveys for ambient radiation exposure rate Yes No N/A 35.2075 Records of the release of individuals containing unsealed byproduct material or implants containing byproduct material Yes No N/A 35.2080 Records of mobile medical services Yes No N/A 35.2092 Records of decay-in-storage Yes No N/A 35.2204 Records of Mo-99, Sr-82, and Sr-85 concentrations Yes No N/A 35.2310 Records of safety instruction Yes No N/A 35.2404 Records of surveys after source implant and removal Yes No N/A 35.2406 Records of brachytherapy source accountability Yes No N/A 35.2432 Records of calibration measurements of brachytherapy sources Yes No N/A 35.2433 Records of decay of Sr-90 sources for ophthalmic treatments Yes No N/A 35.2605 Records of installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and GSR units Yes No N/A
10 CFR 35 Placement Evaluation for CivaDermTM 6
Section Description Applicable Rule Notes 35.2610 Records of safety procedures Yes No N/A 35.2630 Records of dosimetry equipment used with remote afterloader units, teletherapy units, and GSR units Yes No N/A 35.2632 Records of teletherapy, remote afterloader, and GSR full calibrations Yes No N/A 35.2642 Records of periodic spot-checks for teletherapy units Yes No N/A 35.2643 Records of periodic spot-checks for remote afterloader units Yes No N/A 35.2645 Records of periodic spot-checks for GSR units Yes No N/A 35.2647 Records of additional technical requirements for mobile remote afterloader units Yes No N/A 35.2652 Records of surveys of therapeutic treatment units Yes No N/A 35.2655 Records of full-inspection servicing for teletherapy and GSR units Yes No N/A Subpart M - Reports 35.3045 Report and notification of a medical event Yes No N/A 35.3047 Report and notification of a dose to an embryo/fetus or a nursing child Yes No N/A 35.3067 Report of a leaking source Yes No N/A 35.3204 Report and notification for an eluate exceeding permissible Mo-99, Sr-82, and Sr-85 concentrations Yes No N/A Subpart N - Enforcement 35.4001 Violations Yes No N/A 35.4002 Criminal penalties Yes No N/A Additional Considerations