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FDA Medical Device

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I korthet

FDA medical device regulation is a complex gatekeeping system. Software can be classified as a medical device (Class II = 510(k) clearance, ~6 months, $10-50k). Misclassification = regulatory action or recall. Compliance spans design controls, risk management, traceability, validation, post-market surveillance, and QA systems. Most developers have zero exposure. Senior FDA-qualified engineers earn $50-100k premium because they know: when software is a device, which pathway to submit, what documentation FDA expects. Learning the essentials takes 4-6 weeks; mastery takes 2+ years in industry.

Vad är FDA Medical Device

FDA medical device regulation is the U.S. framework governing products that diagnose, treat, prevent, or monitor medical conditions. Software can qualify as a "medical device" if it makes a medical claim. For example, a fitness tracker that just logs steps is a consumer product; a fitness tracker that diagnoses atrial fibrillation is a Class II medical device. Compliance spans design control (formal documentation of development), risk management (FMEA, traceability), software validation, cybersecurity, post-market surveillance, and quality systems (ISO 13485). Submission to FDA takes 6-24 months and costs $50k-$5M+ depending on classification and pathway.

🔧 VERKTYG & EKOSYSTEM
FDA guidance documentsRisk management tools (FMEA, FTA)Quality system documentationDesign control templatesSoftware validation protocolsISO 13485 (quality management)21 CFR Part 11 (electronic records)Post-market reporting systems

💰 Lön per region

OmrådeNybörjareMidErfaren
USA$100k$160k$260k
UK£62k£100k£160k
EU€70k€115k€185k
CANADAC$105kC$170kC$280k

❓ Vanliga frågor

Is my software a medical device?
If it diagnoses, treats, prevents, or monitors a disease, it's a device. Example: sleep tracker alone = no. Sleep tracker + diagnosis of sleep apnea = yes. FDA 21 CFR Part 860 defines device scope.
What's the difference between 510(k) and PMA?
510(k) (Class II): proven substantially equivalent to existing device (~$10-50k, 6 months). PMA (Class III): new technology, needs clinical trials (~$1M+, 18+ months). Most software = 510(k).
What's the typical timeline for FDA submission?
Pre-submission meeting: 4 weeks. Prepare dossier: 8-12 weeks. FDA review: 90-180 days (510(k)) or 6-18 months (PMA). Total: 6-24 months depending on pathway.
Does HIPAA apply to medical devices?
Not directly; HIPAA is about healthcare records. But medical devices often touch PHI (patient data). If storing/transmitting PHI, HIPAA + FDA both apply.
What's design control and why is it required?
Design control = formal process documenting device development (requirements, design, testing, validation). FDA requires it for traceability: from user need to final release. Prevents surprises.

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