Knowledge Base
Practical guidance on 510(k) submissions, AI/ML SaMD, cybersecurity compliance, FDA 483 response, and clinical trial strategy.
Learn the critical differences between FDA establishment registration and device listing under 21 CFR Part 807 — and why your device company needs both to stay compliant.
Learn when De Novo is the right regulatory pathway, how to build a winning request, and what FDA expects — from an expert medical device regulatory consultant.
Learn how to design ASTM F1980 accelerated aging studies that satisfy FDA shelf-life requirements for 510(k), PMA, and De Novo device submissions.
Learn how FDA evaluates real-world evidence in 510(k), PMA, and De Novo submissions. Practical guidance on RWE standards, data quality, and regulatory strategy.
Learn how to choose between a full IDE, abbreviated IDE, or exempt study for your medical device clinical trial. Expert FDA regulatory guidance from ADB Consulting.
Learn how FDA's 2023 software guidance defines Basic vs Enhanced documentation levels and what your 510(k) or PMA submission actually needs to include.
No predicate device? Learn when De Novo is the right FDA pathway, how the process works, and how to build a winning classification request.
No predicate? No problem. Learn how the FDA De Novo pathway works, when to use it, and how to build a winning classification request for your novel device.
Learn how to qualify and audit critical suppliers under FDA QMSR (21 CFR Part 820). Practical guidance for medical device companies navigating supplier controls.
Learn how to build a compliant postmarket surveillance system with expert guidance on complaint handling and MDR reporting under 21 CFR Part 803 and 820.
Learn how FDA Breakthrough Device Designation works, who qualifies, and how to build a winning application strategy. Expert guidance from ADB Consulting & CRO Inc.
Learn when 510(k) submissions require clinical data beyond bench and performance testing — and how to build a defensible evidence package that satisfies FDA reviewers.
Master EO, radiation, and steam sterilization validation for FDA submission. Expert guidance on 21 CFR, ISO standards, and common pitfalls from ADB Consulting & CRO.
Learn how to plan your ISO 10993 biocompatibility test matrix by device contact type and duration — practical guidance for medical device startups and RA teams.
FDA device establishment registration renews October 1–December 31 each year. Learn the fee structure, the renewal window, and what happens if you miss it.
Any establishment that manufactures, repackages, or imports devices for US distribution must register with FDA under 21 CFR Part 807 before placing devices on the market.
Address changes, new devices, ownership transfers, and US Agent changes must be reported to FDA — typically within 30 days of the change — via the FURLS Online Registration System.
Registration identifies who is making the device and where; listing tells FDA what devices are manufactured there. Both are required before US market entry under 21 CFR Part 807.
PMA applications must include valid scientific evidence under 21 CFR 860.7 — typically a well-designed pivotal clinical study. Learn IDE requirements, statistical standards, and the SSED.
FDA has 30 calendar days to review a standard IDE application. Learn what triggers approval, conditional approval, or disapproval — and how to handle deficiencies.
A PMA application for a Class III device requires a device description, clinical data, manufacturing information, SSED, and labeling organized across required modules.
A 513(g) Request for Information asks FDA to identify what device classification applies to your product. Learn what it produces, the 60-day timeline, and when to use it vs. a Pre-Sub.
An EFS gathers preliminary safety data in ≤10 subjects; a pivotal trial is a statistically powered study designed to support PMA or De Novo. Learn FDA's design expectations for each.
Off-label promotion risks warning letters, import holds, and injunctions. Learn what constitutes misbranding under FFDCA Section 502 and the intended-use doctrine.
FDA targets a 180-day review clock for PMA submissions. Understand the decision stages, Day 100 meetings, Additional Information letters, and panel triggers that affect your timeline.
FDA requires each marketed device to be listed under a 3-letter product code tied to its classification. Learn how to find the right code, submit listing in FURLS, and keep listings current.
Foreign manufacturers exporting to the U.S. must register with FDA and designate a U.S. Agent. Learn the requirements, registration process in FURLS, and annual renewal obligations.
A PMA approval triggers ongoing post-market reporting, PMA Supplements for device or manufacturing changes, and possible post-approval studies. Learn which supplement type applies to your change.
A 513(g) request asks FDA for its official view on your device's classification and likely regulatory pathway. Learn the complete submission procedure, required content, and the 60-day response process.
FDA offers in-person, teleconference, and written Q-Sub feedback options. Understanding which type fits your questions helps you get FDA feedback faster and more usefully in your development program.
FDA targets a 60-day response for 513(g) requests. Learn what Class I, II, and III classification responses look like and how to use FDA's response in your downstream regulatory strategy.
FDA targets a 90-day review clock for Traditional 510(k) submissions. Understand FDA user fees, what triggers an Additional Information letter, and realistic total clearance timelines.
FDA device labeling includes the physical label, package inserts, and promotional materials. Learn required elements under 21 CFR Part 801, adequate directions for use, and off-label promotion risks.
FDA issues written meeting minutes within 30 days of a Pre-Submission meeting. Learn how to review minutes for accuracy, document discrepancies, and update your development program accordingly.
FDA may convene an advisory panel for novel or high-risk PMA devices. Understand the panel meeting format, how panel recommendations are made, and how FDA uses panel votes in its final order.
During an active 510(k) or PMA review, the primary channel is through the assigned reviewer. Learn the Interactive Review Program, when to contact FDA proactively, and how to maintain a clear communication record.
Learn when FDA requires human factors and usability engineering data for 510(k) submissions, including key guidance references and what documentation to prepare.
Confused by DHF, DMR, and DHR requirements? Learn exactly what each must contain under 21 CFR Part 820 to stay FDA compliant and audit-ready.
Learn how to draft a compliant PCCP for AI/ML medical devices. Expert guidance on FDA requirements, SPS, IPS, and impact assessment from ADB Consulting & CRO.
Learn when to request an FDA Q-Submission (Pre-Sub) meeting and how to prepare effectively. Expert guidance from ADB Consulting & CRO Inc.
Learn how to draft a compliant PCCP for your AI/ML medical device. Practical guidance on FDA expectations, required elements, and regulatory strategy from ADB Consulting.
FDA regulatory consulting costs, with real published flat fees: 510(k) from $24,500, Pre-Sub $6,500, QMS gap assessment from $3,495, 513(g) from $1,495. No quote games.
Learn how to draft a compliant PCCP for your AI/ML medical device. Practical guidance on FDA expectations, SaMD modifications, and regulatory strategy from ADB Consulting.
Learn how to select a 510(k) predicate device that holds up under FDA review. Expert strategies from ADB Consulting & CRO Inc. to avoid common pitfalls.
Discover the most common FDA 510(k) RTA failures and how to avoid them. Expert guidance from ADB Consulting & CRO Inc. on submitting a complete, reviewable 510(k).
Learn how to build a compliant Predetermined Change Control Plan (PCCP) for AI/ML SaMD under FDA guidance. Expert insights from ADB Consulting & CRO Inc.
Learn how to build a compliant Predetermined Change Control Plan (PCCP) for AI/ML medical devices. Practical FDA guidance for regulatory and quality leaders.
Learn how to build a compliant Predetermined Change Control Plan (PCCP) for your AI/ML medical device. Expert FDA regulatory guidance from ADB Consulting & CRO Inc.
Learn exactly what FDA requires for biocompatibility testing under ISO 10993 and 21 CFR Part 820. Expert guidance for device startups and regulatory teams.
Learn how to draft a compliant PCCP for AI/ML SaMD. Practical guidance on FDA requirements, SPS, IPS, and impact assessment from ADB Consulting & CRO Inc.
Learn exactly what FDA requires for Section 524B cybersecurity documentation in premarket submissions. Expert guidance from ADB Consulting & CRO Inc.
The FDA QMSR replaces 21 CFR Part 820 in 2026. Learn what changed, what your QMS must update, and how to stay compliant before the deadline.
Learn the exact IDE submission requirements under 21 CFR Part 812 before starting your investigational device study. Expert guidance from ADB Consulting & CRO Inc.
Navigate FDA's AI/ML SaMD Action Plan with confidence. Learn the regulatory requirements, submission strategies, and PCCP frameworks your device needs.
Learn what FDA investigators examine during a QSIT audit, which subsystems trigger the most 483s, and how to prepare your QMS before inspection day.
Learn how to design FDA-compliant clinical trials for PMA submissions. Expert guidance on IDE requirements, endpoints, and study design from ADB Consulting & CRO Inc.
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.
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.
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.
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.