ML21089A318
| ML21089A318 | |
| Person / Time | |
|---|---|
| Issue date: | 04/15/2021 |
| From: | Brian Anderson NRC/NMSS/DMSST |
| To: | State of CT, State, Agreement States |
| Katie Tapp, NMSS/MSST | |
| Shared Package | |
| ML21089A263 | List: |
| References | |
| STC-21-020 | |
| Download: ML21089A318 (3) | |
Text
April 20 , 2021 ALL AGREEMENT STATES, CONNECTICUT NOTIFICATION OF ISSUANCE OF REVISION 10.2 OF YTTRIUM-90 MICROSPHERE BRACHYTHERAPY SOURCES AND DEVICES THERASPHERE AND SIR-SPHERES LICENSING GUIDANCE (STC-21-020)
Purpose:
To inform the Agreement States that the U.S. Nuclear Regulatory Commission (NRC) issued a revision to the Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere and SIR-Spheres licensing guidance.
Background:
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.
Discussion: 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.
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).
STC-21-020 2 If you have any questions regarding this correspondence, please contact me at 301-415-3340 or the individual named below:
POINT OF CONTACT: Katie Tapp, Ph.D. E-MAIL: Katherine.Tapp@nrc.gov TELEPHONE: (301) 415-0236 Digitally signed by Brian C.
Brian C. Anderson Anderson Date: 2021.04.20 13:58:41 -04'00' Brian C. Anderson, Chief State Agreement and Liaison Programs Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Revision 10.2, Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere and SIR-Spheres licensing guidance
ML21089A263 *via email OFFICE NMSS/DUWP NMSS/MSST NMSS/MSST NMSS/MSST NAME KTapp* LDimmick* CEinberg* BAndersson DATE 03/31/21 04/15/21 04/15/21 04/20/21