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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

http://www.fda.gov/medicaldevices/deviceregulationandguidance/default.htm