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Notifying Device Supply Disruptions and Manufacturing Discontinuances During Public Health Emergencies

This guidance outlines the requirements and procedures for medical device manufacturers to notify FDA about permanent discontinuances or interruptions in manufacturing that could lead to device shortages during or in advance of a public health emergency (PHE). It implements section 506J of the FD&C Act, which aims to help FDA prevent and mitigate medical device shortages.

  1. Review the FDA’s 506J Device List to determine if your devices require mandatory notifications
  2. Establish internal procedures to:
    • Monitor manufacturing interruptions and discontinuances
    • Submit notifications within required timeframes (6 months advance or 7 days)
    • Provide 4-week status updates
    • Include all required information in notifications
  3. Set up processes to:
    • Track supply chain disruptions
    • Monitor manufacturing capacity
    • Assess potential impacts on device availability
    • Communicate with FDA about potential shortages
  4. Maintain documentation of:
    • Reasons for interruptions/discontinuances
    • Actions taken to prevent/mitigate shortages
    • Communications with FDA
  5. Consider submitting voluntary notifications even for devices not on the 506J list when experiencing supply chain disruptions
  6. Monitor FDA communications about potential PHEs that may trigger notification requirements
  7. Ensure contract manufacturers and suppliers provide adequate notice of any disruptions that could impact notification obligations

Key Considerations

Software

  • Actions or circumstances affecting software-enabled devices that may disrupt healthcare operations (e.g., device cybersecurity vulnerabilities or exploits) should be reported

Cybersecurity

  • Cybersecurity vulnerabilities or exploits that could disrupt healthcare operations should be reported

Other considerations

  • 21 CFR 860.3: Definitions for medical device classification
  • 21 CFR 10.115: Good guidance practices

Original guidance

  • Notifying Device Supply Disruptions and Manufacturing Discontinuances During Public Health Emergencies
  • HTML / PDF
  • Issue date: 2025-01-07
  • Last changed date: 2025-01-06
  • Status: FINAL
  • Official FDA topics: Medical Devices, Postmarket, Biologics
  • ReguVirta summary file ID: be3881dbce8984c60eb914801a9ce3e2
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