As part of its advocacy efforts, AATB sends letters and other communications to the FDA and other government agencies on issues and policies impacting the tissue banking industry and professionals. Read the letters below to learn about the work AATB is doing on these key issues.
Jump to 2023 Government Advocacy Correspondence
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2023 Government Advocacy Correspondence
In Re: Feedback in Response to the CMS Skin Substitutes Town Hall
January 18, 2023
2022 Government Advocacy Correspondence
In Re: CMS-1772-FC, Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Acquisition; etc.
December 30, 2022
In Re: Proposed LCD – Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL) (DL36690)
November 18, 2022
In Re: Draft Guidance – Computer Software Assurance for Production and Quality System Software (Docket No. 2022-19763)
November 14, 2022
In Re: FDA-2022-D-1385, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
September 28, 2022
In Re: Docket No. FDA-2022-D-0745 for “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Draft Guidance for Industry”
September 14, 2022
In Re: Docket No. CMS-1772-P, Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Acquisition; etc.
September 13, 2022
In Re: Docket No. CMS-1770-P, Medicare and Medicaid Programs; CY 2023 Payment Policies under the Physician Fee Schedule and Other Changes
September 6, 2022
In Re: Lessons Learned from Recent Tissue Bank Submissions to the Tissue Reference Group
September 6, 2022
In Re: Docket No. FDA-2021-N-1212, Wound Healing Scientific Workshop; Public Workshop; Request for Comments
June 17, 2022
In RE: Recent MAC Coverage Policies Related to Certain Injectable Birth Tissue Products
March 22, 2022
In Re: CMS-3409-NC, Request for Information: Health and Safety Requirements for Transplant Programs, Organ Procurement Organizations, and End-Stage Renal Disease Facilities
January 31, 2022
2021 Government Advocacy Correspondence
In Re: Special Consideration for HCT/Ps receiving a BLA
October 5, 2021
In Re: Questions and Answers Regarding the End of the Compliance and Enforcement Policy for Certain Human Cells, Tissues, or Cellular or Tissue-based Products (HCT/Ps)
September 7, 2021
In Re: Electronic Summary of Records for 361 HCT/Ps
September 7, 2021
In Re: FDA Safety Communication on March 31, 2021 titled Acellular Dermal Matrix (ADM) Products Used in Implant-Based Breast Reconstruction Differ in Complication Rates
April 7, 2021
2020 Government Advocacy Correspondence
RE: [CMS-3380-P] Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage; Revisions to the Outcome Measure Requirements for Organ Procurement Organizations
February 12, 2020
2019 Government Advocacy Correspondence
Citizen Petition
December 30, 2019