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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Entry 06/27/2016 
FR Recognition Number 15-46
ISO 22442-2 Second edition 2015-11-01 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling.
This part of ISO 22442 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 1 Selective sourcing is considered to be especially important for transmissible spongiform encephalopathy (TSE) risk management.

The manufacturers should refer to ISO 22442-3 for information on the validation of the elimination and/or inactivation of viruses and TSE agents.

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

This part of ISO 22442 does not specify a quality management system for the control of all stages of production of medical devices.

It is not a requirement of this part of ISO 22442 to have a full quality management system during manufacture, but it does specify requirements for some of the elements of a quality management system. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. The quality management system elements that are required by this part of ISO 22442 can form a part of a quality management system conforming to ISO 13485.

NOTE 2 A general principle for the application of this International Standard is that it is advisable to give due consideration to the requirements and recommendations contained in all three parts of the standard.
Extent of Recognition
Complete standard
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.
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FDA recognition of ISO 22442-2 Second edition 2015-11-01 [Rec# 15-46] will be superseded by recognition of ISO 22442-2 Third edition 2020-09 [Rec# 15-65].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.
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.

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.

World Organization for Animal Health (OIE, formerly the Office International Epizooties) Terrestrial Animal Health Code, Chapter 11.4 Bovine Spongiform Encephalopathy.

List of Bovine Spongiform Encephalopathy Risk Status of Member Countries.

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
 David Asher
  240-402-9367 ext: 9367
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.