FDA 510(k) and CE Mark article archive

The Health Tech Investment Act (S.1399) would create a defined Medicare reimbursement pathway for AI medical devices, with mandatory New Technology APC assignment, manufacturer cost-based rates and a five-year payment guarantee. Here is what it would change for digital health reimbursement.

Medicare is building its first dedicated payment structure for algorithm-driven clinical software. Here is what the CY2027 OPPS proposed rule changes, what stays unresolved, and what device and software teams should do before the final rule lands.

How FDA's predetermined change control plan framework works for AI/ML medical devices, what the final guidance requires, what has actually been authorized in 2025–2026, and the limits every submission team should plan around.

Germany and France built named reimbursement routes for digital medical devices. The US still handles software payment case by case. A practical comparison of DiGA, PECAN/LATM and the emerging US pathways, and what it means for market sequencing.

What a design history file must contain under 21 CFR 820.30 and ISO 13485, how the DHF relates to the DMR and DHR, and how to keep it audit-ready.

A practical walkthrough of EU MDR classification: the Annex VIII rules, Class I to III, Rule 11 for software, and what each class means for conformity assessment.

How SaMD is classified and regulated across the US, EU and UK — FDA pathways for software, EU MDR Rule 11, and UKCA and MHRA considerations for digital health teams.

Independent analysts are calling remote monitoring codes "forever codes" because billing continues long after the clinical benefit stops. Here is what that scrutiny means for RPM pricing and contracting.

For software as a medical device, FDA clearance has become the predictable half of the journey. Getting paid is the half that decides whether the product survives.

Independent assessors keep concluding that digital therapeutics show smaller, shorter-lived effects than their marketing claims. Here is what the reviews actually find, and how to build a dossier that survives one.

Health economics and outcomes research is what turns a cleared device into a funded one. Here is what HEOR covers, when to start it, and what payers and HTA bodies actually look for.

The month's regulatory signals, clearances and policy movement across the medical device landscape.

Fourteen countries just cleared the bar for robotic phlebotomy — what their shared conditions say about where to launch next.

Congress froze Medicare clinical lab rates again for 2026 and moved the reporting period. The data labs filed by 31 July 2026 now sets rates for 2027 to 2029. What diagnostics companies should do before January.

A practical method for 510(k) predicate search: what makes a valid predicate, how to use K-numbers and product codes, and how to document substantial equivalence.

CPT, HCPCS and DRG are not interchangeable. Each answers a different question, is maintained by a different body, and determines who gets paid for your device. A plain guide for medtech founders.

FDA has authorised well over 1,000 AI-enabled devices, but only a handful of AI procedures carry their own CPT code — and most of those codes pay nothing. Here is why the gap exists and what to do about it.

How FDA device classification works, how to find the right product code, and what Class I, II and III mean for your premarket pathway.

What UKCA marking requires for medical devices, how MHRA registration and UK Responsible Person duties work, and how the Great Britain route differs from EU MDR.

July 2026 roundup: a SaMD and clinical decision support device focus issue.

Strategic trends to watch and priorities for the next quarter, drawn from recent approval and clearance data.

How to choose between 510(k), De Novo, PMA and exemption — what each FDA premarket pathway requires, how long it takes, and how to tell which one fits your device.

How FDA decides whether your software is a regulated device, how SaMD gets classified by risk, which premarket pathway applies, and what documentation a software submission actually needs.

FDA's digital health device lists and why the September 2026 update matters for teams drawing the line between wellness software and a regulated device.

A Pre-Sub is the cheapest way to find out whether FDA agrees with your pathway, predicate and test plan. Here is what the Q-Submission Program covers, what to ask, and how to run the meeting so the feedback is usable.

FDA De Novo user fees in FY2026 run $173,782 at the standard rate and $43,446 for qualified small businesses. Here is what the small business discount is worth, how to qualify, and the costs the fee schedule does not show.

How predicate devices and the substantial equivalence test actually work, how to search the 510(k) database properly, the traps that sink submissions, and your options when no predicate exists.

What the 510(k) and PMA routes really cost in user fees, review time, evidence and post-market obligations — and how to build the difference into a funding plan.

A practical decision sequence for picking the right FDA premarket pathway — classification, predicate search, risk controls and novelty — and what each route costs you in evidence and time.

The June 2026 regulatory and commercial roundup for medical device teams.

Announcing the MedCompass MVP — market intelligence and regulatory triage built to shorten the path to commercialization.

A closed-loop quality framework for post-market surveillance that feeds real-world signals back into design.

The May 2026 regulatory and market roundup for medical device teams.

Key insights and takeaways for 510(k) study design and data expectations for AI-enabled devices.

Why the product code you pick shapes your submission strategy and your development plan.

Germany is tying part of every DiGA reimbursement price to measured outcomes from 2026. Here is what the AbEM performance measurement requires, what the 20 percent rule does to pricing, and how exporters should respond.

Peer-reviewed research puts the median wait from FDA authorisation to nominal Medicare coverage at 5.7 years. Here is what drives the delay, where the time actually goes, and how to shorten it.

A plain-language guide to the OPPS payment status indicator O1, how status indicators drive hospital outpatient payment, and what the new software category means for SaMD and AI device reimbursement strategy.

Navigating the surge in AI/ML-enabled device approvals and what it means for new entrants.

The Third Party Review Program lets an FDA-recognised organisation review your 510(k) first. Here is who is eligible, what it costs, where it saves time, and when it is the wrong choice.

AI device clearances keep climbing while reimbursement barely moves. Here is why the two curves diverge, what payers ask that FDA does not, and what to do about it before your clearance letter arrives.

CE marking and FDA clearance are not two versions of the same approval. Here is how the evidence, timelines, oversight and market-entry sequencing actually differ, and how to decide which one to pursue first.

What innovators need to know before going to market with software as a medical device.

The April 2026 regulatory and commercial roundup for medical device teams.

FDA, CDRH and global regulatory signals shaping the market.

Choosing the right submission pathway and engaging the FDA early through the Q-Submission program.

How IP strategy should be built into device development and commercialization rather than bolted on.

Why checking the box on AI safety is not enough for regulated medical software.

The March 2026 regulatory and market roundup for medical device teams.

What the FDA's shifting AI guidance means for device developers and their evidence plans.

ISO 13485:2016 defines the requirements for a quality management system — here is what certification involves.

What medical device manufacturers need to know about the new QMS regulation.

Building outcome-oriented organizations for sustainable growth in medical technology.

Health equity and population health outcomes — and what they mean for device access.

A 510(k) premarket notification is a regulatory dossier submitted to the FDA — here is how it works.

A ranking and strategic analysis of the leading AI safety and trust frameworks.

Understanding retrieval-augmented generation systems and how they enhance large language models.