Recordkeeping Requirements and Exemptions for Portable Home Sunlamp Products and UV Lamps
This guidance outlines an exemption from certain recordkeeping requirements for portable home sunlamp products and ultraviolet lamps, specifically regarding dealer and distributor recordkeeping requirements for products with retail prices of $50 or more. The guidance does not apply to suntanning booths or sun beds and couches.
What You Need to Know? 👇
What are the recordkeeping requirements for sunlamp product manufacturers under FDA regulations?
Under 21 CFR 1002, manufacturers must maintain purchaser records from dealers/distributors, and dealers must obtain tracing information for products ≥$50 retail price to enable product recalls and safety notifications.
Are portable home sunlamp products exempt from standard dealer recordkeeping requirements?
Yes, portable home sunlamp products and their UV lamps are exempt from 21 CFR 1002.40 and 1002.41 requirements, but manufacturers must include prepaid postcards for purchaser registration instead.
What information must be included on the mandatory postcard for exempt sunlamp products?
The postcard must have spaces for purchaser name/address, model/serial number, sale date, and include a specific FDA safety statement directing purchasers to return the card for recall purposes.
Does the sunlamp recordkeeping exemption apply to commercial tanning equipment like sun beds?
No, the exemption specifically excludes suntanning booths, sun beds, and couches. These commercial-grade products remain subject to standard dealer and distributor recordkeeping requirements under 21 CFR 1002.40.
Who has the authority to grant exemptions from FDA electronic product recordkeeping requirements?
The Director of the Center for Devices and Radiological Health (CDRH) has authority under 21 CFR 1002.50(b) to exempt manufacturers from all or parts of recordkeeping requirements.
How must manufacturers preserve the completed postcards received from sunlamp purchasers?
Manufacturers must maintain and preserve completed postcard records according to 21 CFR 1002.31 requirements, following the same standards as records received under standard dealer reporting provisions.
What You Need to Do 👇
Recommended Actions
- Implement a post card system that meets all specified requirements
- Establish a record-keeping system for maintaining completed post card information
- Ensure compliance with the Safety Performance Standard for Sunlamp Products
- Develop a process for contacting purchasers in case of safety-related defects
- Create a quality system procedure for managing and maintaining purchaser records
- Establish a recall procedure that utilizes the collected purchaser information
- Regular review of record-keeping system to ensure compliance with 21 CFR 1002.31
Key Considerations
Labelling
- A postage prepaid and preaddressed post card must be included in each product package
- Post card must include spaces for:
- Purchaser’s name and mailing address
- Model and serial number of the product
- Date of sale
- Specific safety statement must appear on the post card regarding FDA Safety Performance Standard compliance
Safety
- Products must meet the Safety Performance Standard for Sunlamp Products
- Manufacturer must maintain system to contact purchasers for safety-related defect corrections
Other considerations
- Manufacturers must maintain and preserve completed post card records according to 21 CFR 1002.31
- Records must enable tracing of products to specific purchasers in case of recall
- Exemption only applies to portable home sunlamp products and their UV lamps
Relevant Guidances 🔗
- Applicability of Sunlamp Performance Standards to UVA Tanning Products (Revoked)
- Exemptions from Reporting Requirements for Limited Production of Sunlamp Products for Commercial Use
- Quality Control and Quality Assurance for Sunlamp Products and UV Lamps
- Compatibility Criteria for Replacement UV Lamps in Sunlamp Products
Related references and norms 📂
- 21 CFR 1002: Records and Reports
- 21 CFR 1002.30: Records to be maintained by manufacturers
- 21 CFR 1002.31: Preservation and inspection of records
- 21 CFR 1002.40: Records to be obtained by dealers and distributors
- 21 CFR 1002.50: Special exemptions
Original guidance
- Recordkeeping Requirements and Exemptions for Portable Home Sunlamp Products and UV Lamps
- HTML
- Issue date: 1995-02-28
- Last changed date: 2018-12-01
- Status: FINAL
- Official FDA topics: Medical Devices, Radiation-Emitting Products, Investigation & Enforcement
- ReguVirta ID: 71817b18e9fa49a78d84ac6543b7675c