FDA CDRH’s “Design Control Guidance For Medical Device Manufacturers ” issued May 11, 1997. This guidance provides explanations related to the design control requirements in the Quality System Regulation 21 CFR 820 Section 30 and ISO 9001 clause 4.4. This guidance has many references to software. It is important to recognize that design control and validation of software is done within the context of design control and design validation for the medical device overall.