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Quality standards
Why have FDA clearance?
Requires a manufacturer to comply with regulations
Encourages higher quality in products Enforces Good Manufacturing Practices (GMP)
- FDA can inspect a facility every 2 years.
Requires a manufacturer to comply with labeling regulations
- Performance characteristics claim
- Accuracy and precision
- Correlation with other methods
- Specificity
- Principles and limitations of procedure
- Specimen collection and handling
- Assay procedures
- Warnings and precautions
- Interpretation of results
- Quality control
510(k) letter for Varian OnTrak TesTcup? and OnTrak TesTstik? (96 kb pdf)
510(k) letter for OnTrak TesTcup? II and On-Site? CupKit™ products (312 kb pdf)
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