The 510 (k) Template - On Disk
Source: Institute of Validation Technology
The traditional 510(k) suggested format including, cover letter sample format, "Truthful and Accurate Statement" form, "Indications for Use" form, and submission sample format
Institute of Validation Technologyonal 510(k) suggested format including, cover letter sample format, "Truthful and Accurate Statement" form, "Indications for Use" form, and submission sample format. Institute of Validation Technologyonal 510(k) suggested format includes:
-Cover letter and sample format
-Truthful and Accurate Statement Form
-Indications for Use Form (Replica of FDA form)
-Submission Sample Format
-Attachments to Sample submission Format
-"Summary of Safety and Effectiveness"
-Possible Abbrevieated 510(k) Risk Analysis Summary Sample
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