Regulatory pathway · all topics

FDA Device Classification (Class I, II, III)

FDA classifies medical devices into three risk-based classes under 21 CFR Parts 862-892. Class I (~47% of devices, low risk): general controls only, most exempt from premarket notification, e.g. tongue depressors, bandages. Class II (~43%, moderate risk): general controls plus special controls and 510(k), e.g. infusion pumps, surgical drapes. Class III (~10%, high risk): general controls plus PMA approval required to support or sustain life or pose unreasonable risk, e.g. heart valves, implantable defibrillators. Classification searchable in the FDA Product Classification Database.

Source

FDA, 'Classify Your Medical Device' (21 CFR 860)

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

How MedTek OS handles this

Compass drafts the fda device classification (class i, ii, iii) 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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