Where can one find Special Controls for a particular device?

Special Controls are typically found in the device-specific classification regulation (e.g., in 21 CFR Parts 862-892) or in FDA guidance documents specifically issued for certain device types.

Do Special Controls always involve testing requirements?

While often including testing, such as bench testing or biocompatibility, Special Controls can also mandate specific labeling, software documentation, or other performance standards tailored to the device's risks.

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Special Controls

Device-type-specific FDA requirements (often performance standards, labeling, or post-market surveillance) that apply on top of General Controls.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 2026

Definition

Special Controls are mandatory for Class II devices and are usually documented in a device-specific classification regulation or Special Controls guidance. They commonly require specific bench testing, biocompatibility, software documentation levels, or labeling statements. Special controls can include performance standards, mandatory testing, specific labeling, postmarket surveillance, patient registries or FDA guidance documents. They are written into the device's classification regulation, often when a De Novo is granted. A 510(k) for a device in that classification must show how each special control is met, typically in a dedicated section of the submission.

What the regulation says

The FDA applies Special Controls to Class II medical devices to provide reasonable assurance of their safety and effectiveness. These controls often supplement General Controls and are outlined in device-specific classification regulations, as per 21 CFR Part 860, Subpart C, or in Special Controls guidance documents.

What this means in practice

Mapping a 510(k) to its product code's Special Controls early prevents late-stage scope surprises and forms the basis of the testing plan.

Examples

A manufacturer of a new Class II infusion pump must adhere to Special Controls that specify performance testing for accuracy and alarm functionality, in addition to general quality system requirements.
For a Class II continuous glucose monitor, Special Controls may require specific clinical accuracy studies and detailed cybersecurity documentation for its wireless communication features.
A company developing a Class II surgical mesh needs to ensure their product meets Special Controls related to biocompatibility testing and labeling for potential adverse tissue reactions.

Common pitfalls

•Failing to identify all applicable Special Controls early in the device development process can lead to significant delays and redesigns.
•Misinterpreting the scope or requirements of a Special Control can result in non-compliant submissions and regulatory hurdles.
•Assuming that General Controls alone are sufficient for a Class II device, neglecting the additional requirements imposed by Special Controls, is a common error.

Frequently asked questions

The primary purpose is to provide specific, device-related requirements beyond General Controls to help ensure the safety and effectiveness of Class II devices.

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510(k) Premarket Notification(510(k))

FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.

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Baseline FDA requirements that apply to all medical devices regardless of class.

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Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.

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513(g) Request for Information(513(g))

Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.

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Abbreviated 510(k)

510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.

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Accreditation Scheme for Conformity Assessment(ASCA)

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Device-type-specific FDA requirements (often performance standards, labeling, or post-market surveillance) that apply on top of General Controls.

·Mapping a 510(k) to its product code's Special Controls early prevents late-stage scope surprises and forms the basis of the testing plan.
·They commonly require specific bench testing, biocompatibility, software documentation levels, or labeling statements.
·Special controls can include performance standards, mandatory testing, specific labeling, postmarket surveillance, patient registries or FDA guidance documents.

Remember this

Watch out: Failing to identify all applicable Special Controls early in the device development process can lead to significant delays and redesigns.

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