FDA 510(k) Glossary · regulatory

Special Controls

Special controls are device-specific FDA regulatory requirements applied to Class II devices in addition to general controls. They may include performance standards, postmarket surveillance requirements, patient registries, or specific guidance documents - and together with general controls provide reasonable assurance of safety and effectiveness for moderate-risk devices.
Dataset Insight - 510k Database (166,200 records, 1980–2025)
Special controls apply to all Class II devices in the dataset. Each product code has specific special controls defined in 21 CFR that manufacturers must address in their 510(k) submission.

Definition

Special controls are regulatory requirements established by the FDA for Class II devices to provide reasonable assurance of safety and effectiveness beyond what general controls alone can achieve. Special controls are device-type specific and are codified in 21 CFR classification regulations for each product code.

Types of Special Controls

  • Performance standards - mandatory compliance with recognized testing standards (e.g., ISO, IEC, ASTM).
  • FDA guidance documents - device-specific guidance that manufacturers must follow or justify deviation from.
  • Postmarket surveillance - requirements to monitor device performance after clearance.
  • Patient registries - participation in registries tracking long-term device outcomes.
  • Labeling requirements - device-specific labeling beyond general controls (e.g., contraindications, warnings).

Special Controls and De Novo

When a novel device is classified through the De Novo pathway, the FDA establishes new special controls as part of the classification order. These new special controls then apply to all future 510(k) submissions for similar devices, as the De Novo device becomes the predicate for the new category.

FDA References

Related Terms

General Controls - Device Classification - De Novo Classification - Product Code

Frequently Asked Questions

Special controls are additional regulatory requirements specific to Class II medical devices. They supplement general controls and may include performance standards (e.g., specific test methods), FDA guidance documents that must be followed, postmarket surveillance requirements, patient registries, or labeling requirements specific to the device type. Special controls are established per product code through classification regulations in 21 CFR.

Special controls are established by the FDA through classification regulations (21 CFR) for each product code. When a new product code is created - for example through a De Novo classification - the FDA issues an order specifying the applicable special controls for that category. Manufacturers must comply with these controls for their 510(k) to be accepted.

Special controls are highly product-specific. For example, a Class II cardiac monitor may require compliance with IEC 60601 electrical safety standards and a specific FDA guidance document on performance testing, while a Class II AI radiology device may require validation against a defined reference dataset. Manufacturers must identify the specific special controls for their product code before preparing their 510(k) submission.