# 21 CFR § 814.19: Product development protocol (PDP)

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-814.19

## Section

- **Citation:** 21 CFR § 814.19
- **Heading:** Product development protocol (PDP)
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES > PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES > Subpart A—General

## Text

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.

## Nearby sections

- [21 CFR § 814.1 § 814.1 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.1.md)
- [21 CFR § 814.2 § 814.2 Purpose.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.2.md)
- [21 CFR § 814.3 § 814.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.3.md)
- [21 CFR § 814.9 § 814.9 Confidentiality of data and information in a premarket approval application (PMA) file.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.9.md)
- [21 CFR § 814.15 § 814.15 Research conducted outside the United States.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.15.md)
- [21 CFR § 814.17 § 814.17 Service of orders.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.17.md)
- [21 CFR § 814.19 § 814.19 Product development protocol (PDP).](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.19.md)
- [21 CFR § 814.20 § 814.20 Application.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.20.md)
- [21 CFR § 814.37 § 814.37 PMA amendments and resubmitted PMAs.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.37.md)
- [21 CFR § 814.39 § 814.39 PMA supplements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.39.md)
- [21 CFR § 814.40 § 814.40 Time frames for reviewing a PMA.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.40.md)
- [21 CFR § 814.42 § 814.42 Filing a PMA.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.42.md)
- [21 CFR § 814.44 § 814.44 Procedures for review of a PMA.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.44.md)
- [21 CFR § 814.45 § 814.45 Denial of approval of a PMA.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.45.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-814.19. Check the current official text before relying on it. Not legal advice.