Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Essential regulatory requirements in the United States related to medical devices intended for human use

Dr. Zoran Pavlovski (Abschlußjahr: 2007)

Summary

Language: English

The current regulatory framework for medical devices in USA was created by the Medical Device Amendments of 1976 (the amendments) to the act, as amended by the Safe Medical Devices Act of 1990, the Medical Device Amendments of 1992, and the FDA Modernization Act of 1997 (FDAMA). The FDA was created and given powers by Congress in the Food Drug and Cosmetics Act. The law can be found in Title 21 of the United States Code. The Regulations of the FDA are contained in the Code of Federal Regulations, Title 21 (referred to as 21 CFR). The regulations that are of particular interest to medical device manufacturers are in Parts 800-1299 of 21 CFR. There are also regulations in Parts 11 and 211 that relate to electronic records and signatures and to the preparations of finished drug products. Section 513(a) of the act [21 U.S.C. 360c(a)] establishes three device classes and directed FDA to publish regulations classifying each device on the market into one of those three classes.

FDA's devices and radiological products program maintains one of the most diverse regulatory portfolios within the Food and Drug Administration. The program consists of the Center for Devices and Radiological Health and a supporting field operation in the Office of Regulatory Affairs.

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels.

The CDRH considers Medical Device Premarket Approval Applications and Supplements, Medical Device Premarket Notifications, and Investigational Device Exemption Applications. It also establishes and enforces regulations governing manufacturing practices and performance standards for the products it regulates.

Furthermore, in order to monitor regulated products after they have been approved, the program operates the MedWatch reporting system, which maintains information about injuries, deaths, and other adverse experiences related to medical devices. The device program also engages in a great deal of postmarket surveillance and field inspections.

The class into which a device is placed determines the requirements that must be met before a manufacturer may distribute the device in interstate commerce. Classification is based on the level of control necessary to provide reasonable assurance of the safety and effectiveness of a device.

The FDA carries out its medical device responsibilities by:

• evaluating new products before they are marketed for conformance to requisite design, engineering bench tests, and data from animal trials or clinical trials in patients;
• assuring quality systems are in place in the device manufacturing plants through inspection and enforcement activities; and,
• collecting and monitoring adverse effects from marketed products and investigations, and taking action to prevent injury or death.

Manufacturers have a responsibility to maintain a quality system (QSRs). Implicit in this system is a responsibility for documentation of quality efforts appropriate to the type of device. The law requires a manufacturer to conduct internal audits at regular intervals, and to have a documented audit procedure.

Postmarket surveillance of already-marketed devices is a vital complement to the premarket review program. Postmarketing reporting is a system through which the FDA receives reports of serious adverse events. Such reporting forms the basis for corrective actions by the FDA, which includes warnings to users and product recalls.

Pages: 62 (Annexes: pages 3)