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Key Roles and Responsibilities

FDA places regulatory obligations on multiple parties in the medical device supply chain. Understanding who owes what obligation is essential for compliance.

US Manufacturers​

A manufacturer is any person who designs, fabricates, assembles, or processes a finished device, or who performs specification development, or final finishing of a finished device. Under 21 CFR Part 820 (QMSR), the manufacturer is primarily responsible for:

  • Maintaining a quality management system
  • Establishing design controls and device history records
  • Submitting premarket notifications or applications
  • Annual establishment registration and device listing
  • Adverse event reporting (MDR) as required

Foreign Manufacturers and US Agents​

Foreign establishments that export devices to the USA must:

  • Register with FDA annually (21 CFR Part 807)
  • Designate a US Agent — a person or entity physically located in the USA who acts as the primary FDA contact for that foreign establishment
  • List all devices they manufacture for US commerce
US-unique

The requirement to designate a US Agent is a US-specific obligation with no direct parallel in most other jurisdictions. The US Agent receives FDA communications on behalf of the foreign establishment and must be reachable during US business hours.

Initial Importers​

An initial importer is any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage or otherwise change the container, wrapper, or labelling of the device.

Initial importers have MDR reporting obligations under 21 CFR Part 803, Subpart D — they must report when they have knowledge of an MDR reportable event.

Distributors​

Distributors who repackage, relabel, or otherwise change a device take on manufacturer-like responsibilities. Repackagers and relabellers are treated as manufacturers and must:

  • Register as a manufacturer
  • Maintain quality system records
  • Submit 510(k)s or PMAs for significant changes resulting from their activities

Device User Facilities​

Device user facilities (DUFs) are hospitals, ambulatory surgical facilities, nursing homes, and outpatient diagnostic or treatment facilities (but not physicians' offices in private practice). DUFs have MDR obligations and must report:

  • Device-related deaths to both FDA and the manufacturer within 10 working days
  • Device-related serious injuries to the manufacturer (or FDA if manufacturer is unknown) within 10 working days

Summary of key obligations by role​

ObligationUS MfrForeign MfrUS AgentInitial ImporterDistributorDUF
Registration✓✓—✓——
Device listing✓✓————
QMS (QMSR)✓✓——Repackagers—
MDR reporting✓✓—✓—✓
Recall reporting✓✓——If repackager—
UDI labelling✓✓——If repackager—

Official resources​