As @JP528 and many others have described the guidelines that the FDA lays out to make sure that you designed a safe product that meets the user needs and requirements as stated in FDA 21 CFR 820.30. I found an interesting website regarding Design controls in the US. and also making the comparison to FDA clauses for Design Controls to ISO 13485 clauses regarding Design & Development.

FDA 820.30_____________________________________Design and Development ISO 13485
(a) General____________________________________7.3.1 Design and development planning
(b) Design and development planning____________7.3.1 Design and development planning
(c) Design input_______________________________7.3.2 Design and development inputs
(d) Design output______________________________7.3.3 Design and development outputs
(e) Design review______________________________7.3.4 Design and development review
(f) Design verifications_______________________7.3.5 Design and development verification
(g) Design validation__________________________7.3.6 Design and development validation
(h) Design transfer ___________________________7.3.1 Design and development planning
(i) Design changes_____________________________7.3.7 Control of Design and development changes
(j) Design history file________________________Not required, no referenced material

As many have stated in other discussions it is interesting that DHF are not required for ISO, but a company does benefit to still have a “living” DHF for internal purposes, development, and auditing purposes.

https://blog.greenlight.guru/design-controls