Medical DevicesLast reviewed April 2026

Special 510(k)(Special 510(k))

An expedited 510(k) pathway for device modifications made by the original manufacturer of a previously cleared device.

Usage Examples

The Special 510(k) for the software update cleared in 25 days based on design control data.
A new component material change qualified for Special 510(k) since intended use was unchanged.

What is Special 510(k)?

A Special 510(k) is an expedited pathway for modifications to the applicant's own previously 510(k)-cleared device. The submission relies on the applicant's established design control procedures under 21 CFR 820.30 (QSR) to demonstrate that the modified device remains substantially equivalent to the applicant's own pre-modification device.

Special 510(k) is available when: the modification is made by the device's current 510(k) holder, the modification does not change the intended use, and design controls appropriately assess the modification's impact. Performance data is typically limited to the specific modification being made. Review target is 30 days — substantially faster than Traditional (90+). Not all modifications qualify; major changes in technology or intended use require Traditional 510(k).

Regulatory Context

This term appears most often in medical devices workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 807, 21 CFR 820 30, FDCA SECTION 510K.

FDA CDRHEMAHealth Canada

When This Matters

The Special 510(k) for the software update cleared in 25 days based on design control data.
A new component material change qualified for Special 510(k) since intended use was unchanged.

Common Mistakes

Using drug-only submission assumptions for device regulatory pathways.
Ignoring post-market obligations in pre-market planning.
Weak predicate and classification rationale in dossier narratives.

Related Regulations

21 CFR 80721 CFR 820 30FDCA SECTION 510K

Frequently Asked Questions

When the modification is by the current 510(k) holder, doesn't change intended use, and design controls appropriately address the change. Major technology changes, new indications, or modifications that raise new safety/effectiveness questions require Traditional 510(k).

FDA target is 30 days for Special 510(k), substantially faster than the 90-day Traditional target. Acceptance is on a day-for-day schedule. Special 510(k) declared eligible at acceptance review proceeds to substantive review quickly.

Yes. If FDA determines during acceptance review that the modification doesn't qualify for Special (e.g., it actually affects intended use), the submission is converted to Traditional and the 90-day review clock applies. Sponsors planning Special should have Traditional content ready if the conversion happens.