Public, medical devices

Congress amended the Federal Food, Drug, and Cosmetic Act (21 U.S. C. 301 et seq.) in 1976 to require premarketing approval of medical devices (Public Law 99-295). 

Medical Devices GMP Codes Parliamentary Secretary s Working Status Document Party on Complementary medicines Medical Releases Publications Site map Related Sites... 

Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 as part of the Homeland Security Act, in response to the terrorism attacks of 11 September, 2001. The new law contains several provisions that are designed to strengthen the public health system generally and the availability of drugs, biological products and medical devices for countering bioterrorism, in particular. 

This site contains information on the health effects and regulation of radiation-emitting devices and products. Protecting the public health by providing reasonable assurance of the safety and effectiveness of medical devices and by eliminating unnecessary human exposure to radiation emitted from electronic products. ... 

Currently only two countries, the United States and New Zealand, permit pharmaceutical manufacturers to market directly to consumers, where consumers are defined as potential ordinary patients and not as health care providers. The United States also now permits direct-to-consumer advertising (DTCA) for prescribed medical devices. Whether DTCA should be permitted at all, permitted but only with much more stringent regulation, or replaced with public health announcements, are issues on which much has been written and continue to be controversial in the United States and in New Zealand. There is also a considerable literature surveying consumers and physicians perceptions of DTCA. ... 

Robert A. Freeman is a 20-year veteran of the global pharmaceutical industry, having led public policy and health economics groups for a number of companies. He is currently Principal of the Freeman Group LLC, a consultancy to the pharmaceutical, biotechnology, and medical device industries. He has widely published in the fields of pharmaceutical policy, industry economics, and technology assessment, and holds adjunct faculty appointments at the Thomas Jefferson University Department of Health Policy and The University of Maryland Center on Drugs and Public Policy. 

The FDA is responsible for the review and market approval of new drugs, biologies, and medical devices in the United States under the authority of the Federal Food Drug and Cosmetic Act (the Act) and Section 351 of the Public Health Service Act (the PHS Act). The FDA defines premarket review as the examination of data and information in an application as described in Sections 505, 510(k), 513(f), 515, or 520(g) or 520(1) of the Act or Section 351 of the PHS Act. This refers to the premarket review of data and information contained in any Investigational New Drug application (IND), Investigational Device... 

The harmonization activity should further the FDA s mission to protect the public health by, among other things, ensuring that food is safe and otherwise not adulterated or misbranded that human and veterinary drugs, human biological products, and medical devices are safe and effective as required by law and are not adulterated or misbranded that cosmetics are not adulterated or misbranded that electronic product radiation is properly controlled and that all of these products are labeled truthfully and informatively. 

Some drugs and medical devices presented in this publication have Food and Drug Administration (FDA) clearance for limited use in restricted research settings. It is the responsibility of the health care provider to ascertain the FDA status of each drug or device planned for use in their clinical practice. 

Assessing risks—and, for drugs and medical devices, weighing risks against benefits—is at the core of FDA s public health protection duties. By ensuring that products and producers meet certain standards, FDA protects consumers and enables them to know what they are buying. For example, the... 

Medical devices are classified and regulated according to their degree of risk to the public. Devices that are life-supporting, life-sustaining, or implanted, such as pacemakers, must receive agency approval before they can be marketed. 

Statements made by, or on behalf of, marketing organizations during promotional audio conferences will also attract regulatory attention if they minimize crucial risk information and promote a drug or device for an unapproved new use. Incorrect, misleading, or incomplete artwork and medical information could lead to the inappropriate use of a drug or medical, device, in which case a recall of that product is usually required. These systems should therefore be validated as they can impact public health. 

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