🇺🇸USA Medical Device Regulations

Quality System Regulation (QSR/QMSR)

FDA Quality System Regulation (cGMP) for medical device manufacturers. Transitioning to QMSR incorporating ISO 13485:2016, effective February 2, 2026.

Medical Device Labeling

FDA labeling requirements for medical devices including general provisions, UDI labeling, OTC requirements, and adequate directions for use.

Unique Device Identification (UDI)

FDA UDI system requirements for device identification, GUDID database submission, and traceability through distribution and use.

Establishment Registration and Device Listing

Requirements for manufacturers and importers to register establishments and list devices with FDA. Foreign establishments must designate a US agent.

Premarket Notification (510(k))

FDA 510(k) premarket notification requirements for Class I, II, and III devices not requiring PMA. Demonstrates substantial equivalence to a predicate device.

Premarket Approval (PMA)

FDA premarket approval process for Class III medical devices requiring demonstration of safety and effectiveness. Includes PMA supplements and HDE.

Investigational Device Exemption (IDE)

Requirements for clinical investigations of medical devices including IDE applications, sponsor and investigator responsibilities, and IRB approval.

Medical Device Reporting (MDR)

Mandatory adverse event reporting requirements for manufacturers, importers, and user facilities. Reports deaths, serious injuries, and malfunctions to FDA.

Medical Device Classification Procedures

FDA classification procedures for medical devices into Class I (general controls), Class II (special controls), or Class III (premarket approval). Includes De Novo classification pathway.

In Vitro Diagnostic Products for Human Use

FDA requirements for in vitro diagnostic (IVD) products including labeling, performance characteristics, and manufacturer responsibilities. Updated May 2024 to include LDTs.