Device Characteristics and Classification
FDA Device Classification
Determine product code and regulatory pathway through intended use analysis and classification database research.
Summary
FDA device classification determines your medical device’s risk class (I, II, or III) and regulatory pathway in the United States, directly impacting your submission requirements, testing obligations, and market access timeline. Classification is based on your device’s intended use, indications for use, and product code assignment rather than physical characteristics. Your classification determines whether you need 510(k) clearance, PMA approval, or qualify for exemptions, making it fundamental to your US regulatory strategy.Why is FDA Device Classification Important?
FDA classification is the foundation of your US regulatory pathway because it determines the level of regulatory control and evidence required for market authorization. Class I devices typically require minimal regulatory oversight, Class II devices usually need 510(k) clearance with predicate device comparison, and Class III devices require PMA approval with extensive clinical data. Misunderstanding your classification can lead to pursuing the wrong regulatory pathway, unnecessary delays, or inadequate preparation for FDA requirements. Your classification also affects your quality system requirements, labeling obligations, and post-market surveillance responsibilities.Regulatory Context
Under 21 CFR Parts 862-892 and Federal Food, Drug, and Cosmetic Act Section 513:- Classification is product code-specific and based on intended use and indications
- Class I: Low risk, minimal regulatory controls (some exempt from 510(k))
- Class II: Moderate risk, usually requires 510(k) clearance and special controls
- Class III: High risk, requires PMA approval with clinical data
Special attention required for:
- Software medical devices - classification based on clinical decision-making impact
- AI/ML devices - may require novel classification or De Novo pathway
- Combination products - each component may have different classification
- Novel devices - may require De Novo pathway to establish new product code
Guide
Start with the FDA Product Classification Database to search for your device type by intended use, device name, or medical specialty. The database provides product codes, classification, and regulatory requirements for thousands of device types. Your product code determines your classification and regulatory pathway. Understand your intended use and indications for use precisely. FDA classification is driven by what your device does clinically, not its physical characteristics. The same physical device can have different classifications based on different intended uses. Document your intended use clearly and search for product codes that match your clinical application. Evaluate existing product codes systematically. Review the classification regulation (21 CFR Part) for your medical specialty area. Each product code has specific classification criteria, special controls, and regulatory requirements. If multiple product codes could apply, choose the one that most closely matches your intended use and technological characteristics. Consider the De Novo pathway for novel devices. If no existing product code adequately describes your device, you may be eligible for the De Novo pathway. This process establishes a new product code and classification for novel, low-to-moderate risk devices. De Novo devices become predicates for future similar devices. Assess special controls and guidance documents. Class II devices typically have special controls (performance standards, labeling requirements, post-market studies) that you must meet. Review FDA guidance documents for your device type to understand specific requirements and expectations. Document your classification rationale thoroughly. Explain why your chosen product code and classification are appropriate based on your intended use, technological characteristics, and clinical application. This documentation supports your regulatory submission and demonstrates your understanding of FDA requirements. Consider software and AI/ML implications. Software medical devices are classified based on their clinical decision-making impact, not their technical complexity. AI/ML devices may require special consideration for algorithm validation, training data, and performance monitoring.Example
Complete FDA Device Classification Analysis
FDA Device Classification Analysis ID: FDA-CLASS-2024-001Device Information
Device Name: CardioWatch Pro Intended Use: Continuous monitoring and recording of heart rate and heart rhythm in adults (18 years and older) in home and clinical settings for healthcare provider reviewProduct Code Analysis
Primary Product Code: MYN Product Code Name: Electrocardiograph, Single Channel Classification: Class II Regulation: 21 CFR 870.2340 Product Code Justification: CardioWatch Pro is appropriately classified under product code MYN based on the following analysis: Intended Use Alignment:- Device records single-channel electrocardiogram (ECG) signals
- Intended for monitoring heart rate and rhythm
- Used by healthcare professionals and patients
- Provides ECG data for clinical interpretation
- Matches the scope of 21 CFR 870.2340 for single-channel electrocardiographs
- Single-channel ECG recording capability
- Dry electrode contact with intact skin
- Digital signal processing and R-wave detection
- Bluetooth connectivity for data transmission
- Mobile application for data visualization
- Continuous monitoring capability (enhancement over typical spot recordings)
Classification Determination
Class II Device- Requires 510(k) clearance before marketing
- Subject to general controls and special controls
- Must demonstrate substantial equivalence to predicate device
- Performance testing demonstrating accuracy of ECG signal acquisition and processing
- Software validation for signal processing algorithms and mobile application
- Electrical safety testing according to IEC 60601-1 and related standards
- Electromagnetic compatibility testing per IEC 60601-1-2
- Biocompatibility assessment for skin-contacting materials
- Labeling requirements including contraindications and user instructions
Alternative Classifications Considered
Product Code DSI (Electrocardiograph, Telephone Transmitting):- Not applicable: CardioWatch Pro uses Bluetooth, not telephone transmission
- Different technology: DSI devices typically use analog telephone lines
- Not applicable: CardioWatch Pro records ECG waveforms, not just heart rate monitoring
- Different scope: DPS focuses on rate monitoring without ECG recording capability
- Not applicable: CardioWatch Pro is single-channel, not multiple-channel device
Regulatory Pathway
510(k) Clearance Required- Must demonstrate substantial equivalence to appropriate predicate device
- Predicate device: AliveCor KardiaMobile 6L (K193869)
- Testing required: Performance, safety, software validation, biocompatibility
- Timeline: Typically 90 days FDA review after submission
- Must comply with 21 CFR Part 820 (Quality System Regulation)
- Design controls required for Class II devices
- Risk management per ISO 14971
- Medical Device Reporting (MDR) for adverse events
- Registration and listing with FDA
- 510(k) required for significant modifications
Q&A
How do I find the right product code for my device?
How do I find the right product code for my device?
Use the FDA Product Classification Database to search by intended use, device name, or medical specialty. Review the classification regulation (21 CFR Part) for your area to understand specific product codes. If multiple codes could apply, choose the one that most closely matches your intended use and clinical application. Consult with regulatory experts if you’re uncertain.
What if my device doesn't fit any existing product code?
What if my device doesn't fit any existing product code?
If no existing product code adequately describes your device, you may be eligible for the De Novo pathway. This process establishes a new product code and classification for novel, low-to-moderate risk devices. Submit a De Novo request with evidence that your device is novel and meets safety and effectiveness standards for its intended use.
Can the same device have different classifications for different uses?
Can the same device have different classifications for different uses?
Yes, classification depends on intended use. The same physical device can have different product codes and classifications based on different intended uses or indications. You must choose the classification that matches your specific intended use and clinical application. You cannot market a device for uses beyond its cleared indications.
How does software affect my device classification?
How does software affect my device classification?
Software classification depends on clinical decision-making impact, not technical complexity. Software that provides information to healthcare providers is typically Class II, while software that makes autonomous clinical decisions may be Class III. AI/ML algorithms require special consideration for validation, training data, and performance monitoring.
What's the difference between Class II and Class III devices?
What's the difference between Class II and Class III devices?
Class II devices typically require 510(k) clearance with predicate device comparison and are subject to special controls. Class III devices require PMA approval with extensive clinical data demonstrating safety and effectiveness. Class III is reserved for high-risk devices that support or sustain life or present unreasonable risk of illness or injury.
Can I change my device classification after FDA clearance?
Can I change my device classification after FDA clearance?
Classification changes require new regulatory submissions. If you modify your device’s intended use or technological characteristics significantly, you may need a new 510(k) or even reclassification. Minor modifications may qualify for special 510(k) procedures. Always consult with FDA or regulatory experts before making significant changes to cleared devices.