# 21 C.F.R. § 807.97 (2026): Misbranding by reference to premarket notification

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_97

## Section

- **Citation:** 21 C.F.R. § 807.97 (2026)
- **Heading:** Misbranding by reference to premarket notification
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES / Part 807: ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES / Subpart E: Premarket Notification Procedures / § 807.97: § 807.97   Misbranding by reference to premarket notification.

## Text

Submission of a premarket notification in accordance with this subpart, and a subsequent determination by the Commissioner that the device intended for introduction into commercial distribution is substantially equivalent to a device in commercial distribution before May 28, 1976, or is substantially equivalent to a device introduced into commercial distribution after May 28, 1976, that has subsequently been reclassified into class I or II, does not in any way denote official approval of the device. Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.

## Nearby sections

- [21 C.F.R. § 807.81 (2026) § 807.81   When a premarket notification submission is required.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_81.md)
- [21 C.F.R. § 807.85 (2026) § 807.85   Exemption from premarket notification.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_85.md)
- [21 C.F.R. § 807.87 (2026) § 807.87   Information required in a premarket notification submission.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_87.md)
- [21 C.F.R. § 807.90 (2026) § 807.90   Format of a premarket notification submission.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_90.md)
- [21 C.F.R. § 807.92 (2026) § 807.92   Content and format of a 510(k) summary.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_92.md)
- [21 C.F.R. § 807.93 (2026) § 807.93   Content and format of a 510(k) statement.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_93.md)
- [21 C.F.R. § 807.94 (2026) § 807.94   Format of a class III certification.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_94.md)
- [21 C.F.R. § 807.95 (2026) § 807.95   Confidentiality of information.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_95.md)
- [21 C.F.R. § 807.97 (2026) § 807.97   Misbranding by reference to premarket notification.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_97.md)
- [21 C.F.R. § 807.100 (2026) § 807.100   FDA action on a premarket notification.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_100.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P807_S807_97. Check the current official text before relying on it. Not legal advice.