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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Entry 06/27/2016 
FR Recognition Number 15-45
Standard
ISO 22442-1 Second edition 2015-11-01 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
Scope/Abstract
This part of ISO 22442 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 part of ISO 22442 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 part of ISO 22442 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 part of ISO 22442 does not specify a quality management system for the control of all stages of production of medical devices.

This part of ISO 22442 does not cover the utilization of human tissues in medical devices.

NOTE 1 It is not a requirement of this part of ISO 22442 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 part of ISO 22442, see Annex A.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized
Clause 4.4.2 , part of sentence: "except where either the animal species is such that manufacturers cannot fully meet the requirements of ISO 22442-2 or an inactivation process in accordance with ISO 22442-3 would cause unacceptable degradation."

Clause 4.4.2 sentence: "For medical devices where an inactivation process causes unacceptable degradation, manufacturers may rely on ISO 22442-2 in order to meet the requirements of this part of ISO 22442."

Clause 4.4.2 sentence: "If the animal species is such that manufacturers cannot fully meet the requirements of ISO 22442-2, they shall demonstrate that the level of inactivation of transmissible agents in a validated manufacturing process, as required in ISO 22442-3, is sufficient to achieve an acceptable level of risk".

Annex C.
Transition Period
FDA recognition of ISO 22442-1 Second edition 2015-11-01 [Rec# 15-45] will be superseded by recognition of ISO 22442-1 Third edition 2020-09 [Rec# 15-64]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 15-45] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 15-45] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
21 CFR 807, 812, 814, 820 and 21 CFR 58
Relevant FDA Guidance and/or Supportive Publications*
Guidance for FDA Reviewers and Industry - Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices), issued November 6, 1998

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 on March 2, 1999

Guidance for Industry and FDA Staff: Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) , Issued March 2019

Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile. Guidance for Industry and Food and Drug Administration Staff. Issued on January 21, 2016.

Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile. Guidance for Industry and Food and Drug Administration Staff. Issued on January 21, 2016.

TSE/BSE letter to Manufacturers of FDA-Regulated Medical Devices Containing Animal Tissue Products or Components. Memorandum.

WHO Tables on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies Updated 2010.
http://www.who.int/bloodproducts/tablestissueinfectivity.pdf

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

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

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
FDA Technical Contacts
 Scott McNamee
  FDA/OC/CDRH/OPEQ/CSPS/
  301-796-5800
  scott.mcnamee@fda.hhs.gov
 David Asher
  FDA/OC/CBER/OBRR/DETTD/LBTSEA/
  240-402-9367 ext: 9367
  david.asher@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Tissue Engineering
*These are provided as examples and others may be applicable.
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