+ Medical Devices Approval Process

+ Objectives Define a medical device Be familiar with the classification system for medical devices Understand the difference between medical device approval and medication approval Define 510(k) Premarket Notification Explain the role of the Food and Drug Administration (FDA) in the medical device approval and review process in the United States

+ Medical Devices The Food, Drug and Cosmetic Act of 1938 defined devices as “Instruments, apparatus, and contrivances, including their components, parts and accessories, intended for use in the diagnosis, cure mitigation, treatment or prevention of disease in man or other animals; or to affect the structure or any function of the body of man or other animals“

+ FDA Role FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation- emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.

+ Classification of Medical Devices Medical devices are classified into Class I, II, and III Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval.

+ Class I Devices: General Controls Class I: Devices for which general controls are sufficient to provide reasonable assurance of safety and effectiveness General Controls are: – Adulteration and misbranding provisions – Registration and listing – Premarket notification (510(k))* (for a limited number of Class I devices) – Records and reports – Good Manufacturing Practices (unless exempt) Examples: scalpels, tongue depressors * 510 (k) submission is to demonstrate substantial equivalence to a device that is already legally marketed.

+ Class II Devices: General Controls and 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

+ 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 and devices that are: (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

+ 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 Once a device is in Class III for a certain indication, all devices of that kind must have a PMA

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

+ Investigational Device Exemption (IDE) Sponsor submits IDE to FDA FDA approves or disapproves within 30 days Sponsor obtains IRB approval After both FDA and IRB approve, sponsor can begin investigation For non-significant risk IDEs sponsor presents protocol to IRB and a statement why investigation does not pose significant risk If IRB approves, investigation can begin

+ Premarket Notification (510(k)) 510(k) 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 is: Has the same use Has the same technological characteristics Does not require same clinical research as required of medications

+ Clinical Data Requirements 90% or more of 510(k) notices do not require clinical data Clearance based on bench testing and/or animal testing, identified through appropriate risk analysis All PMAs generally require clinical data Foreign data may be used but is rarely the sole basis for a PMA

+ Medical Device User Fees User Fees for Device submissions 510(k): $3,833 standard fee PMA, PDP, PMR (reprocessed), BLAs for devices: $259,600 standard fee Reduced fees for small businesses

+ Resources dance/default.htm