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.
What You Need to Know? 👇
What devices require 506J notifications to FDA during public health emergencies?
Manufacturers must notify FDA for devices on the 506J Device List, which includes life-supporting, life-sustaining devices, those for emergency care or surgery, and devices FDA determines are critical to public health during emergencies.
When must manufacturers submit 506J notifications for manufacturing interruptions?
Notifications must be submitted at least six months in advance when possible, or “as soon as practicable” (within seven calendar days) after an interruption occurs or a permanent discontinuance decision is made.
What constitutes a “meaningful disruption” under Section 506J requirements?
A meaningful disruption is a change in production reasonably likely to reduce supply more than negligibly, affecting the manufacturer’s ability to fill orders or meet expected demand for their specific product capacity.
How does FDA determine if a medical device is in shortage?
FDA reviews 506J notifications alongside supply disruption indicators, distribution pressures, demand reports from users, international factors, and mitigation actions to determine if demand exceeds supply within the United States.
What information must be included in 506J notifications to FDA?
Required information includes device name/category, manufacturer name, reason for disruption (from specified categories), estimated duration, plus recommended details like marketing submission numbers, FEI numbers, and FDA product codes.
Can manufacturers submit voluntary notifications outside of public health emergencies?
Yes, Section 506J(h) allows voluntary notifications for life-supporting, life-sustaining, emergency care, or surgery devices at any time, helping FDA monitor supply chains and prevent shortages proactively.
What You Need to Do 👇
Recommended Actions
- Review the FDA’s 506J Device List to determine if your devices require mandatory notifications
- 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
- Set up processes to:
- Track supply chain disruptions
- Monitor manufacturing capacity
- Assess potential impacts on device availability
- Communicate with FDA about potential shortages
- Maintain documentation of:
- Reasons for interruptions/discontinuances
- Actions taken to prevent/mitigate shortages
- Communications with FDA
- Consider submitting voluntary notifications even for devices not on the 506J list when experiencing supply chain disruptions
- Monitor FDA communications about potential PHEs that may trigger notification requirements
- 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
- Manufacturers must notify FDA at least 6 months in advance of a permanent discontinuance or manufacturing interruption, or as soon as practicable (within 7 calendar days)
- Notifications are required for devices on the FDA’s 506J Device List that are critical to public health during a PHE
- Required notification information includes: device category/name, manufacturer name, reason for notification, estimated duration
- Updates should be provided every 4 weeks unless otherwise indicated by FDA
- Manufacturers must explain reasons for discontinuance/interruption
- Failure to notify may result in FDA issuing a public letter
- Voluntary notifications are encouraged for any device supply disruptions even outside of PHEs
Relevant Guidances đź”—
- Requesting Nonbinding Feedback on Form FDA 483 Inspectional Observations
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Postmarket Management of Cybersecurity in Medical Devices
Related references and norms đź“‚
- 21 CFR 860.3: Definitions for medical device classification
- 21 CFR 10.115: Good guidance practices