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What Is an IDE? FDA Investigational Device Exemption Guide 2025
An Investigational Device Exemption (IDE) lets an unapproved or new-use device be used in a U.S. clinical study to collect...
Jun 26, 20256 min read
What Is FDA's Breakthrough Devices Program? Complete 2025 Guide
The FDA Breakthrough Devices Program gives truly novel, life-saving technologies a faster lane through 510(k), De Novo or PMA review. As...
Jun 25, 20256 min read
FDA De Novo Pathway Explained: The Complete 2025 Guide
The De Novo pathway provides marketing authorization for novel, low–to–moderate-risk devices without a predicate , creating a new...
Jun 23, 20256 min read
Pre-market Approval (PMA) Explained: The Complete 2025 Guide
Premarket Approval (PMA) is FDA’s most rigorous pathway, used for most Class III devices (those that support/sustain life, prevent...
Jun 20, 20259 min read
FDA 510(k) Clearance Explained: How It Works (2025 Guide)
A 510(k) premarket notification is how most moderate-risk devices show substantial equivalence to a legally marketed predicate . If...
Jun 19, 20257 min read
SaMD vs SiMD: Quick Comparison for Medical Devices
SaMD (Software as a Medical Device) is software with a medical intended use that works independently of device hardware . SiMD...
Jun 17, 20255 min read
510(k) vs De Novo vs PMA: How to Choose the Right Pathway (2025)
Choosing an FDA pathway hinges on risk, novelty, and predicates. Use 510(k) when a suitable predicate exists for the same intended use...
Jun 12, 20254 min read
Good Machine Learning Practice (GMLP): What It Is & Who Must Follow It
Good Machine-Learning Practice (GMLP) = ten regulator-endorsed principles for AI/ML medical devices, covering data, design, validation,...
Jun 12, 20253 min read
Clinical Evidence for SaMD: Valid Association, Analytical & Clinical Validation
To structure SaMD clinical evidence, build three pillars: valid clinical association (link SaMD output to the condition), analytical...
Jun 10, 20253 min read
FDA Software Validation 2025: What Evidence to Show
In 2025, FDA reviews a risk-based software evidence package per the Device Software Functions (DSF) guidance: choose Basic or Enhanced...
Jun 5, 20252 min read
Documenting AI-Enabled SaMD: What FDA’s Jan 2025 Draft Expects
FDA’s Jan 7, 2025 draft for AI-enabled device software functions recommends including: model description, dataset lineage/partitions...
Jun 3, 20253 min read
FDA SaMD Cybersecurity (2025): §524B, SBOM, Testing & eSTAR
In June 2025 FDA finalized its cybersecurity guidance and clarified §524B obligations for “ cyber devices .” For SaMD that connects to...
May 29, 20253 min read
IEC 62304 + ISO 14971 for SaMD: How to Integrate Lifecycle & Risk
Integrate IEC 62304 (software lifecycle) with ISO 14971 (risk management) by mapping hazards → requirements → design → tests →...
May 27, 20253 min read
FDA SaMD Pre-Submission (Q-Sub): When to Request & What to Include
Use an FDA Pre-Submission (Q-Sub) when your SaMD has novel tech/claims , unclear classification/pathway , clinical evidence questions,...
May 22, 20254 min read
Which FDA Pathway for SaMD? 510(k), De Novo, or PMA (2025)
Choosing a SaMD pathway depends on risk, novelty, and predicates . Use 510(k) when a suitable predicate exists for the same intended use...
May 15, 20253 min read
SaMD Risk Categories (IMDRF): What They Mean & How They Relate to FDA Review
IMDRF categorizes SaMD risk (I–IV) by crossing significance of information (inform, drive, treat/diagnose) with the condition’s...
May 13, 20253 min read
Device Software Function (DSF): FDA’s 2025 AI Draft Definition
“For purposes of this guidance, FDA refers to a software function that meets the definition of a device as a ‘device software function.’”...
May 8, 20253 min read
What Counts as SaMD? FDA Definition in Plain English
Software as a Medical Device (SaMD) = software that has a medical purpose and performs that purpose without being part of a hardware...
May 7, 20254 min read
FDA Unique Device Identification (UDI): Complete Guide for Medical Device Manufacturers
FDA’s UDI system requires most device labels and packages to bear a Unique Device Identifier —in human-readable and AIDC...
Dec 6, 20244 min read
FDA Medical Device Recalls Explained: Causes, Consequences, and How to Avoid Them
An FDA medical device recall is a firm-initiated correction or removal of a violative device, conducted voluntarily and monitored by FDA...
Dec 3, 20246 min read
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