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.