Medical Devices Approval Process

Rev. 10/21/2014

APGO Interaction with Industry: A Medical Student Guide

Learning ObjectivesDefine 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

conditionDoes 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 DevicesMedical devices are classified into Class I, II, and III

Regulatory control increases from Class I to Class III

Class I General controlsClass II General controls with special controlsClass III General controls and premarket approval

Class I Devices: General ControlsClass 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 standardsPostmarket surveillancePatient 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 510k510k 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 useHas 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 ApprovalClass 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 ExemptionInvestigational Device

Is still in the developmental stageIs the object of a clinical investigation to

determine safety and effectivenessIs not considered to be in commercial

distribution

Investigational UseClinical 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 LabelProduct 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/Overview/default.htm

http://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/classifyyourdevice/ucm051512.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm394294.htm