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 …

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 …

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 …

Federal regulatory frameworks governing medical products are designed to (1) provide
evidence that a product benefits patients when used as intended and should be available …

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 …

Importance Postmarketing surveillance is critical to evaluating the safety and effectiveness of
medical devices. The US Food and Drug Administration (FDA) may order the manufacturer …

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 …

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 …

Context Recent debates and events have brought into question the effectiveness of existing
regulatory frameworks for medical devices in the United States and Europe to ensure their …

Patient care for the practicing physician increasingly relies on medical devices. The US
Food and Drug Administration is responsible for the safety and effectiveness of medical …