Navigating Regulatory Pathways for Medical Devices

Regulations vs. Standards

The article distinguishes between regulations (legally binding requirements from agencies like FDA) and standards (ISO frameworks like ISO 13485) that agencies may adopt.

Wellness vs. Medical Device Classification

A critical strategic decision involves product positioning. If you claim your product can diagnose, treat, cure, mitigate or prevent a condition, you've entered medical device territory.

Three U.S. Market Pathways

• 510(k): Most common route (99% annually), demonstrating substantial equivalence
• De Novo: For novel devices with no existing predicate
• PMA: Highest bar for high-risk devices, requiring extensive clinical trials

Quality Management Systems (QMS)

Quality management systems represent how startups ensure personnel and partners operate compliantly. Rather than viewing compliance as mere paperwork, QMS serves as strategic infrastructure that ensures organizational performance.

Progressive implementation advocated rather than overwhelming teams with simultaneous changes.