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In FDA device speak, cleared ≠ approved ≠ granted. Mixing these terms can misbrand your product. FDA cleared means 510(k) approval for...

FDA's Safer Technologies Program (STeP)  is a voluntary  program for devices reasonably expected to significantly improve safety  of...

An FDA medical device recall  is usually a voluntary  action by a firm to remove or correct  a product that violates FDA law , with FDA...

A Software Bill of Materials (SBOM)  is a machine-readable inventory  of every software component in your device—proprietary, OTS, and...

In FDA device world, “ cGMP ” obligations are implemented via the Quality System Regulation (21 CFR 820) . On Feb 2, 2026 , FDA’s Quality...

ISO 13485  is the international QMS standard for medical devices. In the U.S., FDA’s QMSR takes effect Feb 2, 2026 , incorporating ISO...

In 510(k) , substantial equivalence (SE)  means your device has the same intended use  as a predicate  and either the same tech...

An RTA hold  happens when a 510(k)  fails FDA’s acceptance review  and is not accepted  for substantive review; you then have 180 days...

eSTAR  is FDA’s interactive PDF template that structures medical-device submissions in the same layout reviewers use, with built-in...

An FDA Pre-Submission (Q-Sub)  is a voluntary  way to get FDA feedback—by written response and/or a meeting—before or during an IDE,...

An HDE  is a marketing application for a Humanitarian Use Device (HUD) —a device intended to treat/diagnose a condition that affects or...

An Investigational Device Exemption (IDE)  lets an unapproved  or new-use  device be used in a U.S. clinical study to collect...

The FDA Breakthrough Devices Program gives truly novel, life-saving technologies a faster lane through 510(k), De Novo or PMA review. As...

The De Novo  pathway provides marketing authorization  for novel, low–to–moderate-risk  devices without a predicate , creating a new...

Premarket Approval (PMA)  is FDA’s most rigorous pathway, used for most Class III devices  (those that support/sustain life, prevent...

A 510(k) premarket notification  is how most moderate-risk devices show substantial equivalence  to a legally marketed predicate . If...

SaMD (Software as a Medical Device)  is software with a medical intended use  that works independently of device hardware . SiMD...

Choosing an FDA pathway hinges on risk, novelty, and predicates. Use 510(k)  when a suitable predicate exists for the same intended use...

Good Machine-Learning Practice (GMLP)  = ten regulator-endorsed principles for AI/ML medical devices, covering data, design, validation,...

To structure SaMD clinical evidence, build three pillars: valid clinical association  (link SaMD output to the condition), analytical...