eCFR Reference Browser

---

title: "21 CFR §814.19"

source: "https://www.ecfr.gov/current/title-21/section-814.19"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "814"

part_subject: "PREMARKET APPROVAL OF MEDICAL DEVICES"

subpart_code: "A"

subpart_subject: "General"

section_number: "814.19"

section_subject: "Product development protocol (PDP)."

cfr_reference: "21 CFR 814.19"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

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.

§814.19 - Product development protocol (PDP).