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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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)

13. 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

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

15. 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

16. Resources (hyperlinks will be active in presentation mode)
erview/default.htm
view/classifyyourdevice/ucm htm
queDeviceIdentification/default.htm
htm