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What is medical device regulatory compliance?

Medical device regulatory compliance means meeting the applicable obligations for developing, manufacturing, marketing, and monitoring a device. In the United States, these can include classification, premarket review, quality systems, labeling, registration, listing, and post-market reporting. The obligations vary; some devices are exempt from particular requirements. FDA overview of device regulation.

What is an FDA 510(k)?

A 510(k) is a premarket notification demonstrating substantial equivalence to a legally marketed predicate device. FDA evaluates intended use, technological characteristics, and supporting evidence. A successful 510(k) results in clearance. Device-specific exemptions and limitations matter. FDA explanation of premarket notification.

What is the difference between 510(k), De Novo, and PMA?

These pathways are not interchangeable; this is not an exhaustive list. FDA comparison of device review pathways.

What is a predicate device?

A predicate is a legally marketed device used as the comparator for a 510(k) substantial-equivalence assessment. A matching product code or similar name alone does not establish suitability. Review intended use, technological characteristics, legal marketing status, and supporting evidence. FDA predicate and substantial-equivalence definitions.

What is medical device design control?

Design controls are documented processes for translating user needs into design requirements, reviewing development, verifying outputs, validating intended use, transferring design to production, and managing changes. Applicability must be checked against the current quality-system requirements. Under QMSR, design and development requirements are addressed through incorporated ISO 13485 provisions and FDA-specific requirements. FDA QMSR questions and answers.

What is ISO 13485?

ISO 13485:2016 specifies quality management system requirements for organizations involved in medical devices and related services. Certification alone does not establish compliance with every applicable FDA obligation. ISO 13485:2016 standard overview.

What is FDA QMSR?

The Quality Management System Regulation (QMSR) is FDA's revised 21 CFR Part 820. It became effective February 2, 2026, incorporating ISO 13485:2016 by reference alongside FDA-specific provisions. Use the current requirements when assessing quality-system readiness. FDA QMSR FAQ and effective date.

Read about quality-system evidence and readiness.

What is a regulatory readiness assessment?

A readiness assessment is a structured review of available evidence against the requirements relevant to a product and proposed pathway. Teams identify gaps, assign owners, and record unresolved assumptions. A software readiness score is a planning aid; it does not establish regulatory compliance or predict an FDA decision.

Explore evidence-based submission readiness.

How can AI assist regulatory affairs teams?

AI can help organize source material, research pathways, compare candidate predicates, highlight evidence gaps, and prepare drafts for review. eeRegOS supports these workflows through regulatory AI assistance, pathway analysis, predicate search, readiness assessments, document workflows, and expert review. Features depend on available sources, project evidence, configuration, and subscription.

Explore eeRegOS regulatory workflows or compare subscription plans.

What are the limitations of AI in regulatory compliance?

AI output can be incomplete, outdated, or incorrect. Citations must be checked for relevance and currency. Qualified professionals should review product-specific conclusions, evidence, and drafts. eeRegOS does not guarantee clearance, approval, compliance, or submission success, and regulatory decisions remain with the responsible team and authorities.

Read about source-linked drafting and review.