Regulatory pathway · all topics

FDA Design Controls (21 CFR 820.30)

21 CFR 820.30 requires manufacturers of Class II, III, and certain Class I devices to establish design controls. Required elements: design and development planning (820.30(b)), design input (.30(c)), design output (.30(d)), design review (.30(e)), design verification (.30(f)), design validation (.30(g)), design transfer (.30(h)), design changes (.30(i)), and Design History File (.30(j)). The DHF must contain or reference records that demonstrate design was developed in accordance with the design plan and the design controls. Software is governed by 820.30(g) validation linkage to IEC 62304.

Source

FDA, '21 CFR 820.30 Design Controls' and 'Design Control Guidance for Medical Device Manufacturers' (1997)

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-control-guidance-medical-device-manufacturers

How MedTek OS handles this

Compass drafts the fda design controls (21 cfr 820.30) workflow with confidence-gated content.

The platform refuses to generate content below the threshold for this artifact class. Every claim carries a citation chain back to RIG, audit-logged with HMAC integrity.

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