Medical Devices Approval Process APGO Interaction with Industry: A Medical Student Guide Medical Devices Approval Process Rev. 10/21/2014

Learning Objectives Define a medical device Explain the classification system for medical devices Understand the difference between 510(k) Premarket Notification and Premarket Approval for Class II and III devices Describe the goals of the National Postmarket Medical Device Surveillance System Define Unique Device Identification (UDI) system and describe how it is used

What is a Medical Device? Defined by the Food, Drug, and Cosmetic Act of 1938 as: an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: Used to diagnose, prevent, or treat a disease or other condition Does not achieve its purpose through chemical action within or on the body (which would make it a drug) Thus medical devices fall under the jurisdiction of the FDA

Classification of Medical Devices Medical devices are classified into Class I, II, and III Regulatory control increases from Class I to Class III Class I General controls Class II General controls with special controls Class III General controls and premarket approval

Class I Devices: General Controls Class I: Devices for which general controls are sufficient to provide reasonable assurance of safety and effectiveness Examples: scalpels, tongue depressors

Class II Devices: General Controls with Special Controls Class II: Devices for which general controls alone are insufficient to establish safety and effectiveness. Must meet general controls as well as special controls Special Controls are: Performance standards Postmarket surveillance Patient registries, guidelines recommendations, and “other appropriate actions” Examples: Laser for general surgery, diagnostic ultrasound, many intravascular devices Most require a 510k premarket notification

Premarket Notification 510k 510k is a premarket submission to the FDA that demonstrates that the device is substantially equivalent to a legally marketed device What is “substantially equivalent”? The device: Has the same use Has the same technological characteristics Does not require same clinical research as required of medications or Class III devices

Class III Devices: General Controls and Premarket Approval Class III: Devices for which general and special controls alone are not sufficient to establish safety and efficacy: (i) used in supporting or sustaining human life or (ii) are for a use which is of substantial importance in preventing impairment of human health or (iii) present a potential unreasonable risk of illness or injury Examples: artificial hearts, laser for ophthalmic surgery, many spinal implants Most require premarket approval

Premarket Approval Class III devices are subject to premarket approval (PMA) Could be Class III because of high risk or because of lack of predicate device Approval involves submission of clinical data to support claims made by the device manufacturers

Premarket Approval (cont’d) Class II devices require premarket notification via 510k, meaning the device is substantially equivalent to an existing device. Class III devices require premarket approval, a much more stringent process

Investigational Device Exemption Is still in the developmental stage Is the object of a clinical investigation to determine safety and effectiveness Is not considered to be in commercial distribution Investigational Use Clinical evaluation of a legally marketed device for a new intended use

2013 National Postmarket Medical Device Surveillance System: Goals Communicates data-based assessments of the medical risks and benefits of medical devices throughout their marketed life Identifies possible safety issues in near real-time from a variety of data sources Reduces burdens and costs of postmarket surveillance Facilitates approval of new devices or new uses for existing devices Led to creation of a Unique Device Identification System (UDI)

Unique Device Identification (UDI) System The FDA began requiring a UDI system in September 2013 Global UDI Database (GUDID) to provide non- confidential device information to stakeholders and general public Incorporate UDI information into health records through EMRs FDA is also promoting development of International Medical Device Registry for selected products

Example of Fictitious UDI Label Product name Expiration date Reference and lot numbers Manufacturer information Bar code Details about the item

Expedited Process Premarket Approval Application Program Established April 2014 FDA response to criticisms that approval process for Class III devices is too inefficient and slow An attempt to improve patient access to new, helpful products A device may be eligible if it features breakthrough technology with significant benefits over existing products

Resources (hyperlinks will be active in presentation mode) http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Ov erview/default.htm http://www.fda.gov/medicaldevices/deviceregulationandguidance/over view/classifyyourdevice/ucm051512.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Uni queDeviceIdentification/default.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm 394294.htm