1. 1) United States Food and Drug Administration. Guidance for industry and for FDA staff: enforcement priorities for single-use devices reprocessed by third parties and hospitals, document issued on August 14, 2000.
2. 2) United States Food and Drug Administration. Draft guidance for industry and FDA staff: reprocessing medical devices in health care settings: Validation Methods and Labeling, draft document issued on May 2, 2011, latest edition issued on June 9, 2017.
3. 3) Commission for Hospital Hygiene and Infection Prevention (KRINKO), and Federal Institute for Drugs and Medical Devices (BfArM). Hygiene requirements for the reprocessing of medical devices. Recommendation of the commission for hospital Hygiene and infection Prevention (KRINKO) at the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM). Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz, 55(10):1244-1310, 2012 October.
4. 4) Ministry of Health Labour and Welfare. Points to Consider for the reprocessing of single-use devices: Co-signed notification of the Managers of the Evaluation and Licensing Division(0731-No. 8), the Pharmaceutical Safety Division (0731-No. 5), and the Compliance and Narcotics Division and Safety (0731-No. 1), issued on July 31, 2017.
5. 5) Ministry of Health Labour and Welfare. Points to Consider for writing an application for marketing authorization for the reprocessing of single-use devices, Co-signed notification of the Managers of the Evaluation and Licensing Division (0816-No. 3), Ministry of Health, Labour and Welfare, issued on August 16, 2017.