Applicability of Sunlamp Performance Standards to UVA Tanning Products (Revoked)
This guidance addresses the applicability of sunlamp performance standards to UVA tanning products. However, it's important to note that this guidance has been revoked effective June 20, 2002, per Federal Register dated May 21, 2002.
What You Need to Know? 👇
What is the current status of CPG Sec. 396.100 regarding sunlamp performance standards?
This guidance was revoked effective June 20, 2002, per Federal Register notice 67 FR 35827. It is no longer applicable to UVA tanning products and should not be referenced for current regulatory compliance.
How do I find current FDA guidance on radiation-emitting medical devices?
Search the FDA guidance database using keywords like “radiation-emitting products” or “medical devices.” Always verify the publication date and ensure the guidance hasn’t been superseded or revoked before implementation.
What should I do if I’m referencing outdated FDA guidance in my quality system?
Immediately update your documentation to reference current guidance. Conduct a gap analysis to identify any compliance issues and implement corrective actions. Maintain a system for regular guidance review updates.
Where can I submit comments on FDA guidance documents for medical devices?
Submit electronic comments via FDA docket ID: FDA-2013-S-0610. If unable to submit online, mail written comments to FDA’s Dockets Management office in Rockville, MD, clearly identifying the guidance title.
How often should medical device companies review FDA guidance for updates?
Establish a quarterly review process for relevant guidance documents. Subscribe to FDA notifications and maintain a tracking system to monitor revisions, new publications, and revocations that impact your products.
What are the regulatory implications of using revoked FDA guidance?
Using revoked guidance may lead to non-compliance with current standards, potential FDA enforcement actions, and product safety issues. Always verify guidance status and use only current, applicable regulatory documents.
What You Need to Do 👇
Recommended Actions
- Do not rely on this guidance as it has been revoked
- Consult current FDA regulations and guidance documents regarding sunlamp and UV tanning devices
- Review the current performance standards for light-emitting products under 21 CFR 1040
- Seek updated regulatory requirements for UVA tanning products
- Consider consulting with FDA directly for current requirements related to sunlamp and tanning devices
Key Considerations
Other considerations
- This guidance has been revoked and is no longer in effect
- The document was originally related to radiation-emitting products and medical devices
- The guidance was specifically focused on sunlamp performance standards
Relevant Guidances 🔗
- Recordkeeping Requirements and Exemptions for Portable Home Sunlamp Products and UV Lamps
- Regulatory Requirements and Enforcement Actions for Defective Sunlamp Products Manufactured Before May 7, 1980
- Quality Control and Quality Assurance for Sunlamp Products and UV Lamps
- Exemptions from Reporting Requirements for Limited Production of Sunlamp Products for Commercial Use
Related references and norms 📂
- 21 CFR 1040: Performance Standards for Light-Emitting Products
Original guidance
- Applicability of Sunlamp Performance Standards to UVA Tanning Products (Revoked)
- 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: 97825606576e505cb3657d8324853204