Civil Penalties for Electronic Product Radiation Control Violations
This guidance outlines the FDA's policy for assessing civil penalties against manufacturers and importers of electronic products under the Electronic Product Radiation Control provisions of the FFDCA. It specifically details when the Agency will recommend civil penalties, with or without prior warning, for violations related to electronic product radiation control.
What You Need to Know? 👇
What are the civil penalty amounts for electronic product radiation control violations?
Under Section 539(b)(1) of the FFDCA, violations can result in civil penalties up to $1,100 per violation, with a maximum of $330,000 for related series of violations. These amounts are periodically adjusted for inflation under federal law.
When will FDA consider civil penalties without prior warning for electronic product violations?
FDA considers immediate civil penalties when there’s reasonable probability of serious adverse health consequences or death, or when there’s intentional disregard for the law, such as failure to notify FDA of defective products or false certifications.
What constitutes a minor violation that typically won’t result in civil penalties?
Minor violations present little or no risk of injury, such as labels not permanently affixed to products or manufacturer reports that don’t sufficiently explain testing programs. These typically receive written warnings rather than penalties.
Does this guidance apply to assemblers of electronic product components?
No, the terms “manufacturers” and “importers” in this guidance exclude assemblers who take components and assemble, replace, or install them in systems. Separate guidance exists for diagnostic x-ray equipment system assemblers.
What happens if manufacturers refuse to permit FDA inspection or access to records?
Refusal to permit entry, inspection, or access to records by authorized FDA representatives, especially when responding to an inspection warrant, can result in civil penalties without prior warning due to intentional disregard for law.
How does FDA handle repeat violations after initial warnings?
For first-time violations without serious health consequences, FDA typically issues written notification, then a Warning Letter if uncorrected. Civil penalties are considered only if violations continue after these warnings and compliance efforts fail.
What You Need to Do 👇
Recommended Actions
- Establish a robust quality system to ensure compliance with performance standards
- Implement a comprehensive record-keeping system for product distribution
- Develop procedures for prompt FDA notification of product defects
- Create a process for timely implementation of corrective actions
- Establish procedures for proper certification of products
- Maintain complete and accurate records for FDA inspection
- Create a system for tracking and responding to FDA communications
- Develop procedures for notifying purchasers when required
- Train staff on compliance requirements and violation reporting
- Implement a monitoring system to prevent recurring violations
Key Considerations
Labelling
- Labels must be permanently affixed to products
Safety
- Manufacturers must notify FDA upon discovery of product defects
- Products must comply with applicable performance standards
- Manufacturers must implement corrective actions when notified by CDRH
- Manufacturers must notify purchasers when required
Other considerations
- Manufacturers must maintain adequate records for potential recall situations
- Manufacturers must submit required reports completely and adequately
- Manufacturers must allow FDA inspection and access to records
- False certification is subject to penalties
- Maximum civil penalty is $330,000 for related series of violations
- Individual violations can result in penalties of up to $1,100
Relevant Guidances 🔗
- Regulatory Actions and Civil Penalties for Non-Compliant Diagnostic X-ray Equipment Assemblers
- Correction and Reporting Requirements for Diagnostic X-Ray Equipment Defects and Noncompliances
- Model and Serial Number Labeling Requirements for X-Ray System Components
- X-ray Tube Housing Assembly Reloading Facilities: Registration, Listing and Inspection Requirements
Related references and norms 📂
- 21 CFR 17.2: Civil Money Penalties Hearings
Original guidance
- Civil Penalties for Electronic Product Radiation Control Violations
- HTML
- Issue date: 2005-04-01
- Last changed date: 2018-12-01
- Status: FINAL
- Official FDA topics: Medical Devices, Radiation-Emitting Products, Administrative / Procedural, Investigation & Enforcement
- ReguVirta ID: 2b156c2635ddbad9f45c28d6d4d545b4