---
title: "When is a premarket notification (510(k)) submission required before marketing a medical device under 21 CFR 807.81? Answer in under 100 words."
canonical: https://www.m-i-n-d.ai/minds/fda-regulatory/premarket-notification-510-k-submission-required-before-marketing-medical
jurisdiction: "US Federal · FDA (21 CFR 807.81, as of Dec. 16, 2019)"
last_verified: 2026-08-26
license: CC BY 4.0 — https://creativecommons.org/licenses/by/4.0/
attribution: "Source: MIND (m-i-n-d.ai)"
---

# When is a premarket notification (510(k)) submission required before marketing a medical device under 21 CFR 807.81? Answer in under 100 words.

Under 21 CFR 807.81, a 510(k) must be submitted at least 90 days before marketing a device when: the device is first-introduced and not substantially equivalent to a predicate before May 28, 1976 or reclassified; it is first-time by a registrant; or a significant change in design, components, manufacture, or intended use that could affect safety/effectiveness. Exemptions include pending PMA, reclassification petitions, or changes consistent with a cleared PCCP.

## Details / How it works

Under 21 CFR 807.81, each person required to register under §807.20 must submit a premarket notification (510(k)) to FDA at least 90 days before introducing a device into interstate commerce for commercial distribution. The requirement applies to:

- **First-of-a-kind devices** – those not substantially equivalent to a device in commercial distribution before May 28, 1976, or to a device introduced after that date that has since been reclassified into Class I or II.
- **First-time introduction by a registrant** – even if the device itself has been marketed by others.
- **Significant changes or modifications** – changes that could significantly affect safety or effectiveness (e.g., design, material, chemical composition, energy source, manufacturing process) or a major change in intended use.

## Numbers & thresholds

| Factor | Threshold |
|--------|-----------|
| Advance notice | At least 90 days before commercial distribution |
| Predicate date | Devices in commercial distribution before **May 28, 1976** are the baseline for substantial equivalence |
| Reclassification | Devices introduced after May 28, 1976 and later reclassified into Class I or II are also predicates |
| Significant change | A modification that could significantly affect safety or effectiveness triggers a new submission |
| Major intended use change | A major change in intended use triggers a new submission |

## Exceptions & edge cases

A premarket notification is **not required** when:

- A **Premarket Approval Application (PMA)** under section 515 of the Act is pending before FDA.
- A **petition to reclassify** under section 513(f)(2) is pending.
- The change is consistent with a **predetermined change control plan (PCCP)** cleared under section 515C of the Act.

Additionally, the appropriate FDA Center Director may determine that a written request for an exception or alternative under §801.128 or §809.11 satisfies the premarket notification requirement for significant changes under paragraph (a)(3). Manufacturers of radiation-emitting electronic products must also comply with part 1002 reporting requirements.

## Sources

- [1] U.S. National Archives, Electronic Code of Federal Regulations — 21 CFR 807.81 — When a Premarket Notification (510(k)) Submission Is Required · https://www.ecfr.gov/current/title-21/section-807.81 · as of 2026-08-26