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Regulatory pathway · all topics

Premarket Approval (PMA)

PMA is the most stringent FDA pathway, required for Class III devices that support or sustain human life or pose significant risk. Filed under 21 CFR Part 814. Requires valid scientific evidence including clinical investigations under an IDE. Average review time is 180-320 days for original PMAs. Manufacturing quality system inspection (PMA inspection under QSIT) is required before approval. Annual reports and PMA supplements are required post-approval for changes.

Source

FDA, 'Premarket Approval (PMA)' (21 CFR Part 814)

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma

How MedTek OS handles this

Compass drafts the premarket approval (pma) 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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