Knowledge Base
Practical guidance on 510(k) submissions, AI/ML SaMD, cybersecurity compliance, FDA 483 response, and clinical trial strategy.
Miss the FDA annual registration renewal window and your device could be deemed misbranded. Learn deadlines, fees, and how to stay compliant with 21 CFR Part 807.
FDA registration is not FDA approval. Learn what your 510(k) listing actually means, what it doesn't certify, and how to avoid costly compliance mistakes.
Learn what an FDA US Agent is legally required to do, the risks of an unresponsive agent, and how to protect your device's market access under 21 CFR Part 807.
Learn how to identify the correct FDA product code for your medical device, avoid costly misclassifications, and navigate 21 CFR classification with confidence.
Learn when and how to change your FDA US Agent outside the renewal window. Expert guidance on 21 CFR 807 requirements for foreign device manufacturers.
Foreign IDE sponsors often confuse US Agent with US Sponsor of Record. Learn which role you actually need, what each requires, and how to stay FDA-compliant.
Learn exactly what US Agents must do during the FDA annual establishment registration renewal window under 21 CFR Part 807. Expert guidance for device companies.
QMSR replaced QSR in 2024, but many 21 CFR 820 records still apply. Learn which documentation requirements survived the transition and what FDA still expects.
Already ISO 13485 certified? Learn how to read a QMSR gap assessment and close the right gaps before FDA's 2026 enforcement deadline.
Learn what 'locked' means for FDA-cleared AI/ML algorithms, when changes trigger new submissions, and how to plan your regulatory strategy from day one.
FDA's AI/ML SaMD guidance is shifting. Learn how continuous learning systems affect your 510(k), PMA, or De Novo pathway and what your team must do now.
Real-world PCCP scoping strategies for AI/ML SaMD. Learn how leading devices defined change boundaries, SaMD risk tiers, and FDA submission requirements.
Learn how to build a compliant V&V testing strategy for AI/ML medical devices under FDA guidance, 21 CFR Part 820, and the IMDRF SaMD framework.
Learn when a Predetermined Change Control Plan applies vs. a traditional 510(k) supplement for AI/ML SaMD post-deployment changes. Expert FDA regulatory guidance.
FDA cybersecurity requirements for AI/ML connected medical devices explained. Learn what 21 CFR, premarket submissions, and post-market obligations mean for your device.
No predicate for your AI/ML SaMD? Learn how to build a defensible clinical validation strategy using FDA's De Novo pathway and SaMD frameworks.
Learn exactly what FDA expects in a PCCP Modification Protocol section, including required elements, regulatory references, and common submission mistakes to avoid.
Learn what FDA expects for AI/ML explainability in medical device submissions. Practical guidance on transparency, bias, and SaMD documentation for regulatory success.
FDA's AI/ML SaMD framework demands human oversight by design. Learn what human-in-the-loop requirements mean for your diagnostic device submission.
Learn what an FDA consent decree means for device manufacturers, real consequences, and proactive compliance strategies to avoid one. Expert guidance from ADB Consulting.
Learn how to apply IEC 62304 software lifecycle requirements to your FDA 510(k) or De Novo submission. Practical guidance from medical device regulatory experts.
Learn how to build CAPA documentation that satisfies FDA 483 investigators. Expert guidance on 21 CFR Part 820 requirements for medical device companies.
Learn how FDA evaluates substantial equivalence in 510(k) submissions, what breaks your predicate comparison, and how to avoid costly hold letters.
Learn when a 513(g) request gives your medical device startup regulatory certainty before committing to 510(k), De Novo, or PMA. Expert guidance from ADB Consulting.
Learn how FDA classifies Software as a Medical Device (SaMD) and what it means for your regulatory strategy. Expert guidance from ADB Consulting & CRO Inc.
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.
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.
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 when to request an FDA Q-Submission (Pre-Sub) meeting and how to prepare effectively. Expert guidance from ADB Consulting & CRO Inc.
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.
A quick-reference summary of PCCP requirements for AI/ML devices, with links to the full AI/ML SaMD guide and terminology walkthrough.
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 exactly what FDA requires for biocompatibility testing under ISO 10993 and 21 CFR Part 820. Expert guidance for device startups and regulatory teams.
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.
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.
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.
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.
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?
Not every device clinical study requires an IDE. Knowing when FDA exemptions apply can save your company months of preparation time.
Questions?
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