Chapter 5: Regulation of Medical Devices

Investigational Device Exemption (IDE)

Allows the device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or Premarket Notification 510(k) submission to FDA.

(a) Reports of investigations to show whether or not such a device is safe and effective; (b) Statement of the components, chemical composition, and properties; (c) Description of the methods, facilities, and control for the manufacture, processing, packaging, and installation of the device (d) Reference to any relevant performance standards and the device ability to meet the performance standard (e) Sample of the device and components (f) Proposed labeling (g) Certification related to clinical trials (h) Other relevant information the FDA may require

Application for premarket approval for class III devices includes:

Center for Biologics Evaluation and Research (CBER)

Branch of FDA that regulates a group of products collectively referred to as biologics, such as vaccines, blood and blood components, human gene therapy products, tissues, allergenics, somatic cells, recombinant therapeutic proteins, etc

Center for Drug Evaluation and Research (CDER)

Branch of FDA that regulates drugs

Center for Devices and Radiological Health (CDRH)

Branch of FDA that regulates medical devices.

Office of Combination of Products (OCP)

Branch of FDA that regulates products that contnai one or more type, e.g. drug/device.

Special labeling requirements, mandatory performance standards, post-market surveillance and FDA medical device specific guidance, patient registries, FDA medical device specific guidance, guidelines including clinical data in premarket notification

Class II devices are also required to comply with special controls. What are these special controls?

Regulations

Codes that tell the user what to do ad when and under what circumstances to do it

Class III

Devices that are a high risk long term and usually support or sustain life, and are of substantial importance in preventing impairment of human health.

Class III

Devices that are more invasive and can pose immense risk to the user. They are long term devices that have the most stringent regulatory control.

Class I

Devices that are not life supporting or life-sustaining. These are devices that are used to treat illnesses that are not life-threatening, and have the least amount of regulatory control.

Class II

Devices that are typically non-invasive and are external to the body. Also includes short-term devices.

Class I

Devices that do not contact the user internally and preset minimal potential harm to the user. Short term minimum contact and low risk devices, whose failure or misuse is unlikely to cause serious consequences.

Establishment Registration

Domestic and foreign manufacturers and initial distributers (importers) of medical devices must register their establishments with the FDA.

Class III

Examples of these devices include Cardiac pacemakers, intraocular lenses, heart valves, orthopedic implants, total hip and knee replacements, bone graft materials, implantable middle ear heading device, etc.

Class II

Examples of these devices include blood pumps, catheters, contact lens (depending on the type and duration), infusion pumps, ultrasound sensors, hearing aid devices, bone-conducting hearing aid, and tinnitus masker.

Class I

Examples of these devices include crutches, bedpans, tongue depressors, arm slings, breast pumps, endoscopes, etc.

True

For most 510k submission, clinical data are not required and substantial equivalence will normally be determined based on the comparative device descriptions, including performance data.

False

General controls and special controls are known to e sufficient to ensure the safety and efficacy of class III medical devices.

Medical Device Reporting

Incidents in which a device may have caused or contributed to a death or serious injury must be reported to FDA. This regulation is a mechanism for FDA and manufacturers to identify and monitor significant adverse events involving medical devices.

Listing of the Medical Device

Manufacturers must list their devices with the FDA.

Premarket Notification 510(k)

Must demonstrate that the device is substantially equivalent to one legally in commercial distribution in the United States: (1) before May 28, 1976; or (2) to a device that has been determined by FDA to be substantially equivalent.

Premarket Approval (PMA)

Required for regulatory approval of new class III and includes the submission of clinical data to support claims made for the device.

Specification

Set of attributes or requirements to be satisfied by a product, material, process, or system, indicating, when appropriate, the procedure by means of which it may be determined whether the requirements are satisfied

Standard

Something considered by an authority or by general consent as a basis of comparison

True

Standards and specifications are not legally binding

Class II

The failure or absence of this device would have a significant impact on the user, but would not be likely to cause direct serious injury. General controls are not sufficient to assure safety and effectiveness.

Quality System Regulation (QS)/Good Manufacturing Practices (GMP)

The quality system regulation includes requirements related to the methods used in and the facilities and controls used for: designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices.

(i) The same intended use as the predicate medical device, (i) the same technological characteristics as the predicate medical device, or has different technological characteristics but it is safe and effective as legally marketed device, and (iii) does not raise questions of safety and effectiveness than the predicate medical device.

To be substantially equivalent to one legally in commercial distribution in the United States means:

Risk the medical device presents to the user, duration of the device use invasiveness, and level of regulatory control the FDA determines is needed to legally market the device

What are the four basis of classifying devices?

The classification is determined in relation to medical devices that are currently legally marketed.

What is the biggest issue with the FDA classification system?

Pre-market approval notification by approval and FDA review of 510k clearance

What is typically required for Class II devices for market submission?