This video explains the definition of a DHF, a 510(k), and design reviews.
In this video we shared one of our blog articles about the difference between a DHF and a 510(k):
https://medicaldeviceacademy.com/risk-management-requirements/

Although the article focuses on risk management, in the video we talked about the differences between a DHF and a 510(k). We then explained where we recommend you conduct design reviews:
1. At the start of the project, approve your initial design plan and start the DHF
2. After your first pre-sub meeting with the FDA where you review and approve your design input (this should be primarily testing requirements)
3. At the /"design Freeze/" before testing
4. After your safety test and before you do a clinical study
5. After obtaining 510(k) clearance to approve the commercial release of your product

The final review is also when you close your DHF.

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