Source: http://safetygraft.com/wp1/2016/01/06/fda-proposed-guidance-for-sam-surgical-procedure/
Timestamp: 2019-04-19 21:12:08+00:00

Document:
A DRAFT guidance for industry was published in October 2014 by the FDA for Same Surgical Procedure Exemption. I highlighted the line 171 which establishes the need for hospitals to register with the FDA as a tissue establishment. This is a draft guidance for public comment and the public comment period has been reopened until January 7, 2016. In addition there will be a public hearing on April 13 at the FDA office for further input on the subject.
This is primarily for autologous tissue storage for hospitals and trauma centers.
Interestingly, there is no mention of hospitals that recover amnion or umbilical cord at the time of birth and forward it to a tissue or blood bank having a need to be registered.
A log book: This can be a binder with sheets that have spaces to list the kit number, date of recovery, patient name, medical record number and copies of yellow copy of the recovery data sheet that is included in each kit.
There can also be a tab in the log book for training and keep a copy of the in-service sign-in sheet and handout given during the training session.
There should also be a tab with copy of the Certificate of Analysis and Certificate of Sterility of the kit numbers utilized at your hospital.
We provide transport of tissue to the medical examiner in the event of an ME case.
§ 1271.21 – When do I register, submit an HCT/P list, and submit updates?
§ 1271.22 – How and where do I register and submit an HCT/P list?
§ 1271.25 – What information is required for establishment registration and HCT/P listing?
§ 1271.26 – When must I amend my establishment registration?
§ 1271.27 – Will FDA assign me a registration number?
§ 1271.37 – Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings?

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