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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...

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 June 2025  FDA finalized its cybersecurity guidance and clarified §524B  obligations for “ cyber devices .” For SaMD that connects to...

Integrate IEC 62304  (software lifecycle) with ISO 14971  (risk management) by mapping hazards → requirements → design → tests →...

FDA’s UDI system requires most device labels and packages  to bear a Unique Device Identifier —in human-readable  and AIDC...

An FDA medical device recall is a firm-initiated correction or removal  of a violative device, conducted voluntarily and monitored by FDA...

Form FDA 483 (Inspectional Observations)  lists conditions FDA investigators observed at the end of an inspection. It is not  a final...

An FDA import alert  flags products/firms that appear to violate the law and allows detention without physical examination (DWPE) ....

An FDA import refusal  is the agency’s final decision that a detained shipment violates FDA laws. Once refused, the shipment must be...

Startups can meet FDA requirements without burning runway by sequencing the right decisions in the right order. This guide shows how to...

FDA postmarket surveillance means monitoring safety, investigating complaints, filing MDRs within 30 days (or 5-day in certain cases) ,...

FDA regulates medical devices from classification through postmarket monitoring. This beginner’s guide shows how to determine class and...

An FDA warning letter is a public notice of significant violations that requires a written response within 15 working days. This...

Navigating FDA regulations  can feel like walking through a maze. One wrong turn, and your medical device’s path to market  could face...

An FDA warning letter is a public notice that a company significantly violated medical device regulations. Common triggers include QMS...

Non-compliance with FDA regulations can significantly damage medical device companies, both financially and operationally. In this...

TL;DR: Revocations are rare . FDA far more often uses recalls , warning letters , or temporary suspensions to correct problems before...