Randomized clinical studies: an ethical concern.
Explore the source record for details and available documents.
Device Approval↗
Biomedical subjects
G A Rahmoeller
Publications and source records attributed to G A Rahmoeller.
Regulation responsive pacing--and the beat goes on.
Explore the source record for details and available documents.
Humans↗
Cardiovascular device regulation in the United States--views from a former FDA scientist.
Explore the source record for details and available documents.
Assisted Circulation↗
The law on cardiovascular devices: the role of the Food and Drug Administration and physicians in its implementation.
The Medical Device Amendments of 1976 gave the Food and Drug Administration (FDA) new authority to regulate all medical devices. This regulation requires that manufacturers provide data supporting the safety and effectiveness of new and modified devices before marketing them, and eventually provide similar data even for devices now on the market. Those working in the cardiovascular field use a device every day of their professional lives; therefore, the Medical Device Amendments will have a significant effect on everyone in the field. We must understand the law so that we can provide scientific guidance to the FDA and to the medical device industry; in this article we aim to provide the necessary information.
Cardiovascular Diseases↗
Transthoracic ventricular defibrillation with very high amplitude rectangular pulses.
Explore the source record for details and available documents.
Animals↗
Clinical use of the micromodule pacemaker receiver.
Explore the source record for details and available documents.
Aged↗