What guidance is applicable to hospital reprocessors that are sterilizing SUDs?
Answer. FDA has guidance documents that apply generally to all types of manufacturing processes including sterilization. For example, the “Guideline on General Principles of Process Validation” applies to sterilization activities as well as to other manufacturing processes. FDA documents relating to the Quality System (QS) regulation also are applicable for sterilization processes. These documents are located on the Internet at Quality Systems Regulations. General guidance is available from other sources such as the Global Harmonization Task Force document entitled “Process Validation Guidance for Medical Device Manufacturers.” Many national and international consensus standards provide specific sterilization processes. We encourage you to become familiar with these standards. FDA has worked closely with other experts from industry, healthcare facilities, and academia in developing these standards for the various types of sterilization processes commonly used for medical devices. FDA r
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