| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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055
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Date of Entry 12/21/2020
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FR Recognition Number
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15-65
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| Standard | |
ISO 22442-2 Third edition 2020-09
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling |
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Scope/AbstractThis document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442-1.
NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats.
This document does not cover the utilization of human tissues in medical devices.
This document does not specify a quality management system for the control of all stages of production of medical devices. |
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| Extent of Recognition
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Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Transition Period
| FDA recognition of ISO 22442-2 Second edition 2015-11-01 [Rec# 15-46] will be superseded by recognition of ISO 22442-2 Third edition 2020-09 [Rec# 15-65]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 15-46] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 15-46] will not be accepted. |
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| Public Law, CFR Citation(s) and Procode(s)*
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Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry and FDA Staff: Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices), issued March 2019.
2. Guidance for FDA Reviewers and Industry: Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices), issued November 1998.
3. Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh, issued March 1999.
4. Guidance for Industry and Food and Drug Administration Staff: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued January 2016.
5. TSE/BSE letter to Manufacturers of FDA-Regulated Medical Devices Containing Animal Tissue Products or Components. Memorandum.
6. WHO Tables on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies Updated 2010.
http://www.who.int/bloodproducts/tablestissueinfectivity.pdf
7. World Organization for Animal Health (OIE, formerly the Office International Epizooties) Terrestrial Animal Health Code, Chapter 11.4 Bovine Spongiform Encephalopathy.
http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_bse.htm
8. List of Bovine Spongiform Encephalopathy Risk Status of Member Countries.
http://www.oie.int/animal-health-in-the-world/official-disease-status/bse/list-of-bse-risk-status
9. Bovine Spongiform Encephalopathy; Importation of Bovines and Bovine Product; Final Rule by Animal and Plant Health Inspection Service, USDA. Federal Register Vol. 78, No 233, 72980-73088. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
