Device Classification Notes

Device Classification

Introduction

  • Medical device classification is crucial for marketing approval in most regions.
  • Classification determines the need for a marketing application, the type of evidence required, and the kind of application needed.
  • Incorrect classification can lead to expenses, including application fees and inadequate studies.
  • It also affects time to market, potentially requiring additional studies and resubmission with the correct application type.

North America

United States
  • Initial question: "What type of medical product are we developing?" to determine if it's a drug, biologic, or medical device.
  • Define the intended use and indications for use of the medical product.
  • Intended Use: The device's general purpose or function, including indications for use.
  • Indications for Use: Describes the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended.
  • Compare the product's characteristics against the definition of a medical device in Section 201(h)(1) of the Federal Food, Drug and Cosmetic Act (FDCA) (21 USC 321(h)(1)) or the definition of an in vitro diagnostic (IVD) medical device in 21 CFR §809.3.
  • IVDs are further discussed in Chapter 33: In Vitro Diagnostic Medical Devices.
  • Determine if the device has an existing product code to understand its possible classification.
  • The FDA uses a risk-based classification system based on the device's risk and the controls needed to mitigate that risk.
  • FDA classification procedures are in 21 CFR §860, with classification panels in 21 CFR §862-892.
  • Each device is assigned a three-letter product code used to search classification panels or the product code database.
  • The product code is also on the medical device listing form.
  • Product codes offer more specific designations within a classification regulation.
  • Both the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) use product codes.
  • FDA has classified 1,700 generic device types into 16 medical specialties (panels).
  • Generic Device Type (21 CFR §860.3): A grouping of devices that do not differ significantly in purpose, design, materials, energy source, function, or any other feature related to safety and effectiveness, and for which similar regulatory controls are sufficient to provide reasonable assurance of safety and effectiveness.
  • Medical specialties range from clinical chemistry (21 CFR Part 862) to radiology devices (21 CFR Part 892).
  • All medical devices fall into one of these 16 classification panels.
  • The FDCA defines three classes based on risk, complexity, and necessary regulatory controls:
    • Class I (low to moderate risk): General controls (with or without exemptions).
    • Class II (moderate to high risk): General and special controls (with or without exemptions).
    • Class III (high risk): General controls and premarket approvals.
  • New devices not previously marketed before the 1976 Medical Device Amendments are automatically classified as Class III.
  • Novel devices can be classified via the de novo route or a 513(g) request.
Class I Devices
  • Class I devices are low-to-moderate risk and are covered by general controls.
  • General controls are baseline controls that apply to all medical devices unless exempted.
  • General control requirements include:
    • Adulterated devices - FDCA 501
    • Misbranded devices - FDCA 502
    • Establishment registration - FDCA 510
    • Device listing - FDCA 510
    • Premarket notification (510(k)) - unless exempt
    • Notifications (recalls) - FDCA 518
    • Records and reports (adverse event, tracking, unique device identification system, medical device reporting) - FDCA 519
    • Good manufacturing practices (GMPs) or Quality Management System Regulations - FDCA 520
  • Labeling is also a general control and includes labels on the device and accompanying literature, such as instructions for use. Labeling requirements are in 21 CFR Part 801.
  • Most Class I devices (approximately 74%) are exempt from premarket notification (510(k)).
  • Class I devices may also be exempt from GMPs.
  • Regulatory professionals can check the FDA website Medical Device Exemptions 510(k) and GMP Requirements to check exemptions.
  • Examples include tongue depressors, band-aids, examination gloves, visual acuity charts, and toothbrushes.
Class II Devices
  • Class II devices are moderate-to-high risk, requiring more than general controls.
  • General controls apply, as well as special controls, typically device-specific.
  • Special controls include:
    • Performance standards
    • Postmarket surveillance
    • Patient registries
    • Special labeling requirements
    • Premarket data requirements
    • Guidelines
  • Some Class II devices are exempt from premarket notification and GMPs.
  • Most Class II devices require premarket notification (510(k)) for marketing clearance.
  • Examples include echocardiograms, intraoral devices for snoring and sleep apnea, and ophthalmoscopes.
Class III Devices
  • Class III devices are high risk, typically life-supporting or life-sustaining, implantable, or presenting unreasonable risk of illness or injury.
  • General controls apply, but premarket notification is insufficient; a premarket approval application (PMA) must be filed and approved.
  • Class III transitional and new devices are automatically classified into Class III.
  • Regulatory professionals can submit a PMA, Product Development Protocol (PDP), or a petition for reclassification into Class I or Class II.
  • Per 21 CFR §814.19, a PDP deemed completed by FDA means the Class III device is considered to have an approved PMA.
  • Examples include ventricular bypass assist devices, transabdominal amnioscopes and accessories, and silicone gel-filled breast implants.
513(g) Request for Information
  • A 513(g) Request for Information can establish device classification.
  • Section 513(g) of the FDCA mandates the Secretary to provide a written statement of classification and applicable requirements within 60 days of a written request.
  • The 513(g) request should include:
    • Signed cover letter
    • Description of the device
    • Description of intended use
    • Proposed labeling or promotional material and, if available, similar material from a legally marketed device.
  • The cover letter should include:
    • Date of the request
    • Name of the device
    • Specific questions about the device's class and/or regulatory requirements
    • Requester's contact information
    • Requester's signature
  • The device description should include:
    • List of materials and components
    • Photographs, engineering drawings, and/or samples
    • Summary of operational principles (e.g., software/firmware)
    • Description of energy used or delivered
    • Description of similar devices in commercial distribution, if available
  • Device uses should include:
    • Disease or condition for which the device is to be used
    • Prescription versus over-the-counter
    • Part of the body or type of tissue applied to or interacted with
    • Frequency of use
    • Physiological purpose (e.g., removes water from blood)
    • Patient population
    • Environment of use (e.g., laboratory)
    • Any other relevant labeling information
  • The 513(g) request need not meet eCopy requirements or be submitted electronically but can use the 513(g) electronic Submission Template and Resource (eSTAR).
  • The user fee must be paid before, during, or immediately after submission; the fee for fiscal year 2025 is 7,301.157,301.15
  • FDA will respond within 60 days of receipt, confirming the product meets the definition of a medical device.
  • The response will include:
    • The generic type of device
    • Class of devices
    • Whether a PMA, 510(k), or neither is required
    • Other applicable requirements
    • Guidance documents regarding enforcement discretion
    • Whether additional requirements may apply
    • If the medical product is not a medical device
  • FDA's responses are not device classification decisions, clearance, or approval; will not describe required testing; and do not constitute final FDA action.

Reclassification

  • Anyone can petition the FDA to reclassify a device; FDA can also initiate reclassification.
  • New data must be provided to the FDA to justify reclassification.
  • Manufacturers typically seek to down-classify devices, with the burden of proof resting on them.
  • It must be proven that general controls and special controls or general controls alone will assure the device's safety and effectiveness.
  • Reclassification could reduce the number and types of studies, user fees, and other benefits.
  • Reclassification regulations are in Sections 513(e), 513(f), 514(b), 515(b), and 520(l) of the FDCA.
  • The reclassification process affects all devices within the generic type.
  • A reclassification petition must contain:
    • Specification of the device type
    • Statement of the action requested
    • Statement of disagreement with the current classification
    • Full statement of reasons with supporting data
    • Representative data unfavorable to the petitioner's position
    • A summary of new information
    • Financial certification or disclosure statement per 21 CFR Part 54
  • A classification panel may review the petition and provide a recommendation or the classification can be changed by administrative order after publication in the Federal Register.
  • The reclassification process should be completed within 180 days of receiving the petition.
  • Between 2013 and November 2024, six devices were reclassified from Class I or II to Class II or III, and 24 devices from Class III to Class I or II.
  • Section 515 of the FDCA provides for reclassification of Class III devices.
  • The FDA regulated over 170 Class III device types through the 510(k) program initially, intending these regulations to be temporary.
  • As of 2009, 26 regulations still required reclassification; FDA began the 515 Initiative Program to finish reclassifying the remaining devices.
  • The FDA must complete five tasks under the 515 process:
    • Task A: Collect existing scientific information and assess risks versus benefits.
    • Task B: Convene a Medical Device Advisory Committee meeting.
    • Task C: Issue a proposed order.
    • Task D: Review and consider public comments.
    • Task E: Issue a final order.
  • As of 2019, FDA has reclassified 16 devices to either Class I or II via the 515 Initiative Program.

Canada

  • Canada's Medical Device Regulations (MDR) (SOR/98-282) classify devices using a risk-based approach.
  • There are four classes: Class I (lowest risk) to Class IV (highest risk).
  • 16 classification rules apply to all medical devices and help determine device class, establishing the need for a Medical Device Establishment License (MDEL) (Class I) or a Medical Device License (MDL) (Class II-IV).
  • Classification rules are in Schedule 1 of the MDR.
  • Canada uses risk indicators, including degree of invasiveness, duration of contact, body system affected, and local versus systemic effects.
  • Long-term use is continuous use for 30 or more days.
  • Health Canada views the intended use as the primary determinant of device class.
  • If a device falls under more than one classification rule, the higher risk classification rule applies.
  • The 16 classification rules are broken into four sets:
    • Invasive Devices - Rules 1-3
    • Noninvasive Devices - Rules 4-7
    • Active Devices - Rules 8-12
    • Special Rules Rules 13-16
  • Regulatory professionals should know if the device is invasive, noninvasive, or active (requires an energy source).
  • Definitions for these terms are in the classification guidance document.
  • If a device shares characteristics, the higher classification must be applied. Check Rules 13-16 to ensure these Special Rules do not apply.

Europe

European Union
  • The EU's classification system is similar to Canada's risk-based system.
  • There are four classes: Class I, Class IIa, Class IIb, and Class III with 22 classification rules.
  • There are four sets of rules: invasive, noninvasive, active, and special.

Asia, Latin America, Middle East, North Africa, and Oceania

  • Chapter 24 contains device classification information for:
    • China
    • Japan
    • India
    • South Korea
    • Taiwan
    • Singapore
    • Malaysia
    • Vietnam
    • Brazil
    • Colombia
    • Mexico
    • Australia
    • New Zealand
    • Saudi Arabia

Conclusion

  • Classification systems are risk-based, using the device's intended use.
  • Most jurisdictions have three or four classes.
  • Classification rules provide detailed information to assist regulatory professionals.
  • Lower-class devices have lower risk; higher-class devices have higher risk.
  • Some jurisdictions use criteria such as invasiveness or whether a device is active.
  • Regulatory professionals should understand their jurisdiction's classification system because classification directly correlates to the evidence needed and the type of marketing application required.