Knowledge Base
Practical guidance on 510(k) submissions, AI/ML SaMD, cybersecurity compliance, FDA 483 response, and clinical trial strategy.
Learn how to design a clinical trial that satisfies FDA's PMA requirements — from IDE applications to statistical power, endpoints, and pivotal study strategy.
Learn how FDA classifies Software as a Medical Device (SaMD) under 21 CFR and iSaMD guidance—and how to choose the right regulatory pathway for your product.
Understand how FDA classifies Software as a Medical Device under 21 CFR and IMDRF guidelines. Practical guidance for startups and regulatory teams.
FDA now requires SBOMs for connected medical devices. Learn what's required, which guidance applies, and how to build compliance into your premarket submission.
Learn how Section 524B of the FD&C Act impacts your 510(k) or PMA submission. Practical cybersecurity guidance for medical device startups and regulatory teams.
Navigate the FDA PMA process with confidence. Learn Class III device requirements, submission structure, and common pitfalls from regulatory experts.
Learn how to use FDA Pre-Submission (Q-Sub) meetings strategically to de-risk your 510(k), De Novo, or PMA submission before you file.
A practical ISO 13485 implementation guide for medical device companies—covering QMS structure, FDA alignment, common gaps, and how to avoid costly mistakes.
Understand how FDA's Digital Health Center of Excellence impacts SaMD, AI/ML, and connected device developers—and how to align your regulatory strategy.
Master ISO 14971 risk management for FDA medical device compliance. Learn the core framework, FDA alignment, and common pitfalls to avoid before your next submission.
The FDA's evolving approach to AI/ML in medical devices has created both new opportunities and new complexity. Here's a practical breakdown of the current regulatory landscape.
An FDA Form 483 observation is not a Warning Letter — but how you respond in the first 48 hours determines whether it stays that way.
Since March 2023, FDA has been refusing 510(k) submissions that don't meet the new cybersecurity requirements under Section 524B. Is your submission compliant?
Choosing the wrong predicate device is the #1 cause of 510(k) deficiency letters. Here's a systematic approach to predicate selection that maximizes clearance probability.
Not every device clinical study requires an IDE. Knowing when FDA exemptions apply can save your company months of preparation time.
Questions?
Every device situation is different. Book a free 30-minute call and get tailored regulatory advice from Andre Butler.