Medical Device FDA Compliance

FDA classifies medical devices into three classes based on risk. Start by identifying the product code and classification panel using FDA's product classification database. Class I devices are low risk with general controls. Class II devices require special controls and typically a 510(k). Class III devices are high risk and require Premarket Approval (PMA). If your device has no predicate, the De Novo pathway may apply.

A 510(k) is a premarket notification submitted to FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. The submission must include: device description, predicate comparison, performance data, labeling, and biocompatibility data (if applicable). FDA review takes approximately 90 days. A cleared 510(k) allows you to market the device.

Yes, all establishments that are involved in the production and distribution of medical devices intended for use in the United States must register with FDA. This includes manufacturers, contract manufacturers, repackagers/relabelers, specification developers, and initial distributors of imported devices. Registration must be renewed annually between October 1 and December 31.

The Unique Device Identification (UDI) system requires most medical devices to bear a unique identifier on their label and packages. The UDI consists of a device identifier (DI) and a production identifier (PI). UDI data must be submitted to FDA's Global Unique Device Identification Database (GUDID). Implementation varies by device class, with Class III devices required first.

The QMSR (21 CFR Part 820, as amended) replaced the legacy QSR effective February 2, 2026, aligning FDA requirements with ISO 13485:2016. Key elements include: management responsibility, design controls, document controls, purchasing controls, production controls, CAPA, and complaint handling. QMSR incorporates ISO 13485:2016 by reference while retaining FDA-specific additions. All manufacturers must comply regardless of device class.

MDR requires manufacturers, importers, and user facilities to report certain device-related adverse events to FDA. Manufacturers must report: deaths and serious injuries within 30 days, malfunctions that could cause death or serious injury within 30 days, and 5-day reports for events requiring remedial action. Failure to report is a serious violation that can result in warning letters and penalties.

Yes, foreign manufacturers exporting medical devices to the US must register their establishment with FDA. They must also designate a US Agent who serves as FDA's point of contact. Additionally, the initial importer must be registered as well. Foreign manufacturers must comply with QSR requirements and are subject to FDA inspections.

The De Novo pathway is for novel medical devices that are low-to-moderate risk but have no predicate device, making them ineligible for 510(k). If granted, the device is classified into Class I or II and can serve as a predicate for future 510(k) submissions. The De Novo process requires more clinical/performance data than a 510(k) but less than a PMA.