--- title: "Special Controls, Definition | MedTech Terms" description: "Device-type-specific FDA requirements (often performance standards, labeling, or post-market surveillance) that apply on top of General Controls." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/special-controls#term", "name": "Special Controls", "description": "Special Controls are mandatory for Class II devices and are usually documented in a device-specific classification regulation or Special Controls guidance. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Special Controls [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Post-Market & Safety](/ecosystems/post-market-safety)[Global Markets](/ecosystems/global-markets) # 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 Cyber](/authors/christian-espinosa) Last reviewed May 5, 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](/terms/biocompatibility), software documentation levels, or [labeling](/terms/labeling) statements. 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](/terms/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 What is the primary purpose of Special Controls? The primary purpose is to provide specific, device-related requirements beyond [General Controls](/terms/general-controls) to help ensure the safety and effectiveness of Class II devices. Where can one find Special Controls for a particular device? Do Special Controls always involve testing requirements? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory General Controls Baseline FDA requirements that apply to all medical devices regardless of class. ](/terms/general-controls) ### More in Regulatory · Same category [ Regulatory 510(k) Summary vs 510(k) Statement 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. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k)[ Regulatory Accreditation Scheme for Conformity Assessment(ASCA) FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny. ](/terms/asca) Cited by Where this term appears across MedTech Terms. Ecosystems (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Post-Market & Safety](/ecosystems/post-market-safety) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 IMDRF· 1 RAPS· 1 FDA· 1 1. [1 IMDRF Documents Verified IMDRF · imdrf.org ](https://www.imdrf.org/documents) 2. [2 RAPS Regulatory Focus Verified RAPS · raps.org ](https://www.raps.org/news-and-articles/news-articles) 3. [3 FDA - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=special-controls) Learn in 60 seconds Card Lesson Quiz 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. Remember this Watch out: Failing to identify all applicable Special Controls early in the device development process can lead to significant delays and redesigns. Related terms - [General Controls ](/terms/general-controls) - [510(k) Premarket Notification(510(k)) ](/terms/510k) You may also need Auto-suggested from Regulatory and shared keywords. - [Common Specifications (IVDR)(CS) ](/terms/ivdr-common-specifications) - [General Safety and Performance Requirements (IVDR)(GSPR) ](/terms/ivdr-gspr) - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) - [De Novo Classification Request(De Novo) ](/terms/de-novo) - [AI Act Technical Documentation (Annex IV) ](/terms/ai-act-technical-documentation) - [CE Mark ](/terms/ce-mark) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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