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Human Factors Engineering (HFE), also called usability engineering, is how FDA expects you to show that intended users can operate your device safely and effectively in the intended use environment, especially when use error could cause harm. For many higher-risk device types, FDA often expects human factors data in 510(k)s and PMAs, and it is common to see it in De Novo programs when the user interface drives risk. If you change a user interface in a way that can affect comp

A new 510(k) is required if a modification could significantly affect the safety or effectiveness of the device  or represents a major change in intended use , per 21 CFR 807.81(a)(3) . FDA expects manufacturers to use its 2017 decision flowcharts  and a documented, risk-based assessment comparing the change to the most recently cleared device . Poor decisions can lead to costly enforcement, recalls, or unnecessary submissions. Every medical device company with a cleared 510(

FDA 510(k) submissions most often stumble on preventable issues: incomplete or non-compliant admin packets at Refuse to Accept (RTA) review, weak or inconsistent device descriptions and indications for use, poor predicate selection, missing or insufficient testing data, and failure to follow device-specific FDA guidance. Historically, RTA refusal rates have climbed as high as ~60% of new 510(k)s, and even in recent years roughly one-third of submissions hit an RTA hold at lea

FDA device inspections follow QSIT (Quality System Inspection Technique). Set a host/scribe front room  and SME back room , stage core QMS records ( design controls, CAPA, complaints, process controls ), rehearse interviews, and track every document request. On arrival, log Form FDA 482 ; at closeout, capture the exact 483  wording and submit a written CAPA  (Corrective And Preventive Action) response within 15 business days . This guide provides the systematic approach regul

FDA compliance for medical devices isn't optional - it's the gateway to the largest medical device market. In the US, “FDA compliance” means: classify  the product (Class I/II/III), choose the correct route— 510(k) clearance , De Novo classification , PMA approval , or 510(k)-exempt —run a compliant quality system  (QSR until Feb 2, 2026 ; QMSR  afterward), apply labeling/UDI  rules, register & list  establishments/devices, and meet postmarket  duties (MDR 803, corrections/re

Importing medical devices into the United States requires strict FDA compliance, and the stakes are massive. Medical device importers must ensure premarket compliance (510(k)/PMA), establishment registration and listing, proper CBP filing codes (DEV, LST, PM#), and ongoing MDR obligations. Foreign manufacturers need US agents while initial importers must maintain complaint files in the US. Products that don't meet requirements face detention, refusal, and destruction, often c

FDA requires medical device labeling to include manufacturer information, intended use, adequate directions, warnings, UDI (where applicable), and device-specific requirements. Labeling encompasses all written materials including labels, packaging, instructions for use, and promotional materials. Compliance requires both content accuracy and quality system controls under 21 CFR 820.120. This guide covers all FDA labeling requirements, common violations, and compliance strateg

CMS New Technology Add-on Payment (NTAP) is the fastest path to Medicare reimbursement for by providing additional Medicare payments...

Medical device companies expanding globally face a critical strategic decision: which regulatory pathway offers the fastest, most...

A medical device Quality Management System (QMS)  proves you can consistently design, make, and support safe, effective devices. It's...

A Predetermined Change Control Plan (PCCP) is FDA documentation that lets you pre-define specific AI/ML software changes—and the methods...

FDA requires packaging that protects devices from alteration or damage  through processing, storage, handling, and distribution ( 21 CFR...

In the US, reimbursement for medical devices rests on three pillars: coding , coverage , and payment . Coding assigns CPT/HCPCS  and,...

UDI  is FDA’s Unique Device Identification  system: most device labels and packages  must carry a UDI  in machine-readable (AIDC)  and...

The Safe Medical Devices Act of 1990  amended the FD&C Act and reshaped US postmarket controls. It created mandatory user-facility MDR...

The FDA’s Center for Devices and Radiological Health (CDRH) regulates medical devices in the United States. Devices reach the market via...

Medical device post-market surveillance is a comprehensive FDA requirement for manufacturers to systematically monitor device...

FDA is replacing 21 CFR 820 (Quality System Regulation) with the Quality Management System Regulation (QMSR) on February 2, 2026,...

FDA AI medical device regulation received major updates with comprehensive draft guidance for artificial intelligence-enabled devices. On January 7, 2025 , FDA issued draft guidance  for AI-enabled device software functions (DSF)  that applies a Total Product Life Cycle (TPLC)  approach. It recommends  what to include in submissions: model description, data lineage/splits, performance tied to claims, bias analysis/mitigation, human-AI workflow, monitoring, and—if you’ll updat

Medical device adverse event reporting MDR (21 CFR Part 803)  requires manufacturers, importers, and device user facilities  to report certain device-related deaths, serious injuries, and malfunctions to FDA. Manufacturers/importers must file electronically (eMDR) since Aug 14, 2015 ; user facilities are not required to e-submit. Manufacturer timelines: 30-day MDRs  and 5-day  reports for urgent risks or when FDA requests. This comprehensive guide provides medical device comp