| 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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15-64
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| Standard | |
ISO 22442-1 Third edition 2020-09
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management |
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Scope/AbstractThis document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the
residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as:
a) contamination by bacteria, moulds or yeasts;
b) contamination by viruses;
c) contamination by agents causing transmissible spongiform encephalopathies (TSE);
d) material responsible for undesired pyrogenic, immunological or toxicological reactions.
For parasites and other unclassified pathogenic entities, similar principles can apply.
This document does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an international standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.
This document does not specify a quality management system for the control of all stages of production of medical devices.
This document does not cover the utilization of human tissues in medical devices.
NOTE 1 It is not a requirement of this document to have a full quality management system during manufacture. However, attention is drawn to international standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices.
NOTE 2 For guidance on the application of this document, see Annex A.
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
| Clause 4.4.2, Paragraph 4 |
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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.
This standard is recognized in part because Clause 4.4.2, Paragraph 4 is in conflict with section IV C. (paragraph 2, page 8) of the FDA guidance (reference #1) listed below. |
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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.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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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. |
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