It looks like FDA is not familiar with your IRB and may never have inspected it before. Provide the full name, address, institution name, contact email and phone number. If there is a webpage, add that as well.
If you've already provided that, call the FDA contact to ask specifically. They are very helpful with such clarifications.
Good luck!
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Andrea Chamblee Esq., RAC, FRAPS
Senior Counsel, Wilson Sonsini
This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and as a RAPS Fellow.
This is not intended as legal advice. Consult a lawyer for your specific matter.
Maryland
United States
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Original Message:
Sent: 24-Feb-2022 13:09
From: Anonymous Member
Subject: IRB Identification
This message was posted by a user wishing to remain anonymous
Hi all,
We recently submitted a Q-Sub regarding a test plan for our Class II SaMD. One of the questions in the feedback we received was - "....you state "(HIPAA)-compliant study protocol that will be executed under the approval of [IRB name]" However, we were unable to locate any additional information regarding the identity of the referenced institution. Please provide additional information on the location where the study will take place and identify which institution is associated with the study."
What information is expected for the identity of the IRB? Are search results from the Dept of HHS database -
Office for Human Research Protections Database| Nih | remove preview |
| | Office for Human Research Protections Database | | Use the following tabs to search the OHRP database Please note: the fact that an Institutional Review Board (IRB) is registered with the Office for Human Research Protections (OHRP) does not mean that OHRP has determined that the IRB reviews research in accordance with the requirements of the Department of Health and Human Services (HHS) Protection of Human Subjects regulations, 45 CFR part 46, and does not mean that the IRB has the appropriate competence or expertise to review a particular research project. | | View this on Nih > |
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- enough, or is additional information required?