As with new drugs, the US Food and Drug Administration's approval process is intended to
provide consumers with assurance that, once it reaches the market place, a medical device …

Over the last 150 years, the US Food and Drug Administration (FDA) has evolved from a
small division of the US Patent Office to 1 of the largest consumer protection agencies in the …

Importance US law generally requires testing of high-risk medical devices prior to approval,
as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring …

The regulation of medical drugs and devices involves competing goals of assuring safety
and efficacy while providing rapid movement of innovative therapies through the …

Prior to and since the passage of the Medical Device Amendments of 1976, Congress has
debated how best to ensure that consumers have access, as quickly as possible, to new and …

Over 8000 new medical devices are marketed in the United States each year. Before
marketing, manufacturers of high-risk, or class III, devices provide the Food and Drug …

We propose the following definition of a medical device:“A contrivance designed and
manufactured for use in healthcare, and not solely medicinal or nutritional.” Current …

Importance The US Food and Drug Administration (FDA) approves high-risk medical
devices, those that support or sustain human life or present potential unreasonable risk to …

Background: Unlike prescription drugs, medical devices are reviewed by the US Food and
Drug Administration (FDA) using 2 alternative regulatory standards:(1) premarket approval …

Background Policymakers and regulators in the United States (US) and the European Union
(EU) are weighing reforms to their medical device approval and post-market surveillance …