---
title: "What changes to a marketed medical device require a new premarket notification? Answer in under 100 words. Cite only eCFR (www.ecfr.gov) sources."
canonical: https://www.m-i-n-d.ai/minds/fda-regulatory/device-changes-requiring-new-510k
jurisdiction: "US Federal"
last_verified: 2026-08-27
license: CC BY 4.0 — https://creativecommons.org/licenses/by/4.0/
attribution: "Source: MIND (m-i-n-d.ai)"
---

# What changes to a marketed medical device require a new premarket notification? Answer in under 100 words. Cite only eCFR (www.ecfr.gov) sources.

Under 21 CFR 807.81(a)(3) (as amended at 89 FR 18792, Mar. 15, 2024), a new premarket notification (510(k)) is required when a device already in commercial distribution is about to be significantly changed or modified in design, components, method of manufacture, or intended use. The rule defines two categories of significant change: (i) any change that could significantly affect safety or effectiveness (e.g., in design, material, chemical composition, energy source, or manufacturing process), and (ii) a major change or modification in the intended use of the device.

## Details / How it works

Per **21 CFR 807.81(a)(3)**, a person who is required to register under § 807.20 must submit a premarket notification at least 90 days before introducing a significantly changed or modified device into interstate commerce.

The regulation identifies two categories of significant change or modification that trigger a new 510(k):

- **Changes affecting safety or effectiveness** — e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.
- **Major change in intended use** of the device.

The baseline list of devices exempt from notification (because they are substantially equivalent) is set out in § 807.81(a)(1), referencing devices in commercial distribution before May 28, 1976, and devices reclassified into class I or II after that date.

## Numbers & thresholds

| Item | Value | Source |
|---|---|---|
| Minimum lead time before commercial distribution | 90 days | 21 CFR 807.81(a) |
| Pre-1976 commercial distribution baseline date | May 28, 1976 | 21 CFR 807.81(a)(1)(i) |
| Most recent amendment date | Mar. 15, 2024 (89 FR 18792) | 21 CFR 807.81 |

## Exceptions & edge cases

Under **21 CFR 807.81(b)(1)**, a premarket notification is **not** required when:

- A premarket approval application (PMA) under section 515 of the FD&C Act, or a petition to reclassify under section 513(f)(2), is pending before FDA; or
- There is a **Predetermined Change Control Plan (PCCP)** cleared under section 515C of the FD&C Act, provided the change is consistent with that PCCP.

Under **21 CFR 807.81(b)(2)**, the appropriate FDA Center Director may also determine that a written request for an exception or alternative granted under § 801.128 or § 809.11 satisfies the § 807.81(a)(3) requirement.

Under **21 CFR 807.81(c)**, owners or operators that manufacture radiation-emitting electronic products (as defined in § 1000.3) must additionally comply with the reporting requirements of part 1002.

## 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 2026-08-27