ML21089A283
| ML21089A283 | |
| Person / Time | |
|---|---|
| Issue date: | 04/19/2021 |
| From: | Christian Einberg NRC/NMSS/DMSST/MSEB |
| To: | Mary Muessle, David Pelton, Blake Welling Decommissioning, ISFSI, and Reactor Health Physics Branch, Division of Nuclear Materials Safety III, Division of Nuclear Materials Safety IV |
| Katie Tapp, NMSS/MSST | |
| Shared Package | |
| ML21089A263:ML21106A291 | List: |
| References | |
| Download: ML21089A283 (3) | |
Text
April 19, 2021 MEMORANDUM TO: Blake D. Welling, Director Division of Radiological Safety and Security Region I David L. Pelton, Director Division of Nuclear Materials Safety Region III Mary C. Muessle, Director Division of Nuclear Materials Safety Region IV Signed by Einberg, Christian on 04/19/21 FROM: Christian E. Einberg, Chief Medical Safety and Events Assessments Branch Division of Materials Safety, Security, State and Tribal Programs Office of Nuclear Material Safety and Safeguards
SUBJECT:
NOTIFICATION OF ISSUANCE OF REVISION 10.2 OF YTTRIUM-90 MICROSPHERE BRACHYTHERAPY SOURCES AND DEVICES THERASPHERE AND SIR-SPHERES LICENSING GUIDANCE On March 21, 2021, Boston Scientific received its premarket approval (PMA) from the U.S.
Food and Drug Administration (FDA) for TheraSphere. Previously, TheraSphere was approved by the FDA under the provisions of a Humanitarian Device Exemption (HDE) which require unique restrictions on the medical use of the device. Sirtex Medicals PMA for the Sir-Sphere Y-90 resin microspheres was approved by the FDA March 5, 2002.
In previous revisions of the licensing guidance, Section 7.3 provides information on the TheraSphere HDE, and the associated requirements for use of the device under an HDE.
Specifically, an Institutional Review Board (IRB) must review and approve initial use of an HDE device before it is used at a facility. Further, if the IRB determines that the particular use is for research purposes, the licensee must meet the requirements in Title 10 Code of the Federal Regulations (10 CFR) 35.6, Provisions for the protection of human research subjects.
Because TheraSphere now has a PMA, an IRB review and approval is no longer required.
CONTACT: Katie Tapp, NMSS/MSST (301) 415-0236
B. Welling, et al. 2 Therefore, Section 7.3, which described the HDE and IRB requirements for TheraSphere, was removed the licensing guidance. Note requirements in 10 CFR 35.6 would still apply if a licensee conducts research described in 10 CFR 35.6(b).
Enclosure:
Revision 10.2 ,Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere and SIR-Spheres licensing guidance
ML21106A291; Memo ML21089A283 NMSS/MSST/MSEB OFFICE NMSS/MSST/MSEB NMSS/MSST/MSEB
/MRST NAME KTapp KT LDimmick LD CEinberg CE DATE Apr 16, 2021 Apr 19, 2021 Apr 19, 2021