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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 814 - Premarket Approval of Medical Devices |
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Subpart A - General |
§ 814.19 - Product development protocol (PDP).
Latest version.
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§ 814.19 Product development protocol (PDP).
A class III device for which a product development protocol has been declared completed by FDA under this chapter will be considered to have an approved PMA.