Knowledge Base
Practical guidance on 510(k) submissions, AI/ML SaMD, cybersecurity compliance, FDA 483 response, and clinical trial strategy.
Navigate FDA's AI/ML SaMD regulatory requirements under the 2021 Action Plan. Expert guidance on predetermined change control plans, transparency, and 510(k) strategy.
Learn what clinical evidence FDA requires for De Novo classification requests, including study design, data standards, and common pitfalls to avoid.
Received an FDA Warning Letter? Learn a proven, step-by-step remediation strategy with specific 21 CFR references to close out findings and protect your business.
Master FDA UDI compliance under 21 CFR Part 830. Practical guidance on GUDID submission, labeling requirements, and avoiding costly enforcement actions.
Learn the specific FDA post-market surveillance requirements for cleared devices—MDR, MDR exemptions, complaint files, and PMS planning under 21 CFR.
Navigate FDA's SaMD classification framework with confidence. Learn how 21 CFR, IMDRF, and FDA guidance apply to your software product before you submit.
Section 524B mandates cybersecurity submissions for medical devices. Learn what FDA requires, key deadlines, and how to build a compliant security program.
Learn how to implement ISO 13485 for medical devices—covering FDA alignment, documentation, risk management, and audit readiness for startups and growing companies.
Learn when the FDA De Novo pathway applies to your medical device and how to build a submission that clears the first time. Expert guidance from ADB Consulting.
Learn how the FDA 510(k) process works, what substantial equivalence means, and how to avoid costly mistakes that delay clearance for your medical device.
Learn how ISO 14971 risk management aligns with FDA expectations under 21 CFR Part 820 and how to build a defensible risk management file for your device.
FDA is intensifying cybersecurity enforcement for medical devices. Learn what Section 524B, premarket submissions, and postmarket expectations mean for your strategy.
Master FDA medical device labeling under 21 CFR 801. Practical guidance on required elements, common mistakes, and compliance strategies for device companies.
Master FDA design controls under 21 CFR Part 820. Practical guidance on design inputs, outputs, verification, validation, and DHF documentation for device teams.
Prepare your medical device company for an FDA QSIT inspection. Learn what investigators examine, common findings, and how to avoid a Form 483.
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.