Should my hospital comply with the Quality System regulation even if the SUDs that we are reprocessing do not require premarket submissions to the FDA?
Answer. Yes. Regardless of whether or not the SUDs that your hospital is reprocessing require premarket submissions, your hospital should comply with the requirements of the Quality System regulation [which also is referred to as the current Good Manufacturing Practice (cGMP)] as described in 21 CFR Part 820 (see Appendix question #7 below).
Related Questions
- What sterilization activities does FDA expect in a hospital reprocessor that is reprocessing single-use devices (SUDs)?
- Is the CEO of a hospital responsible for quality policy and implementation under the Quality System (QS) regulation?
- How is The Methodist Hospital System focused on quality and safety?
