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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 123 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 103 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 52 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 33 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 293 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 273 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 224 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 153 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 133 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 83 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 74 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
FDA Form 483: What It Means and How to Respond Effectively
Form FDA 483 (Inspectional Observations) lists conditions FDA investigators observed at the end of an inspection. It is not a final...
Nov 29, 20244 min read
STeP for Medical Devices: FDA’s Safer Technologies Program Explained
FDA’s Safer Technologies Program (STeP) is a voluntary pathway for devices (and device-led combos) that are reasonably expected to...
Nov 26, 20246 min read
FDA Import Alerts: A Guide for International Medical Device Companies
An FDA import alert flags products/firms that appear to violate the law and allows detention without physical examination (DWPE) ....
Nov 21, 20244 min read
FDA Import Refusals for Medical Devices: What They Are and How to Avoid Them
An FDA import refusal is the agency’s final decision that a detained shipment violates FDA laws. Once refused, the shipment must be...
Nov 14, 20245 min read
How Long Can FDA Approval Take? Understanding Timelines for Different FDA Pathways
For medical device companies, understanding the FDA approval timeline is critical. Knowing how long the process might take helps companies plan more accurately, manage resources effectively, and set realistic expectations for investors and stakeholders. However, the time to obtain FDA approval can vary significantly depending on the regulatory pathway and the complexity of the device. This guide provides a breakdown of typical timelines for the major FDA approval pathways—510
Nov 12, 20246 min read
FDA Q-Submission (Q-Sub) Program: How Early Feedback Streamlines Approval
The FDA Q-Submission (Q-Sub) Program lets device teams request written feedback or a meeting before and during submissions. Core types...
Nov 6, 20245 min read
FDA Compliance Guide for Medical Device Startups
Startups can meet FDA requirements without burning runway by sequencing the right decisions in the right order. This guide shows how to...
Nov 5, 20245 min read
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