MedicalDevice版 - Federal Panel Calls for Overhaul in Medical-Device Regulation |
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A*****8
发帖数: 8590 | 1 http://online.wsj.com/article/SB1000142405311190363560457647585
An influential outside panel called Friday for a broad overhaul of U.S.
medical-device regulation, saying the Food and Drug Administration should
give more intense scrutiny to thousands of devices that currently receive
only a quick review before going on the market.
If the FDA follows the advice of the Institute of Medicine committee, it
could lead to the some of the biggest changes in decades in the system that
decides how thousands of products ranging from artificial joints to heart-
surgery devices reach U.S. patients. The sweeping nature of the
recommendations appeared to take many by surprise.
.......
The abbreviated approval of medical devices has come under heightened
scrutiny in recent years, including cases of some metal-on-metal hip
implants that produce metal debris, inflammation and other problems.
........
The FDA said it will seek public comment on the IOM recommendations. "FDA
believes that the 510(k) process should not be eliminated but we are open to
additional proposals and approaches for continued improvement" of the
existing system, said Jeffrey Shuren, director of the FDA's device center.
An extensive overhaul would likely involve both congressional and FDA
regulatory action. | w*********l
发帖数: 5144 | 2 nice.等斑主来了发bz
that
【在 A*****8 的大作中提到】
: http://online.wsj.com/article/SB1000142405311190363560457647585
: An influential outside panel called Friday for a broad overhaul of U.S.
: medical-device regulation, saying the Food and Drug Administration should
: give more intense scrutiny to thousands of devices that currently receive
: only a quick review before going on the market.
: If the FDA follows the advice of the Institute of Medicine committee, it
: could lead to the some of the biggest changes in decades in the system that
: decides how thousands of products ranging from artificial joints to heart-
: surgery devices reach U.S. patients. The sweeping nature of the
: recommendations appeared to take many by surprise.
| ot
发帖数: 4549 | 3 IOM paper 让FDA别在510(k)上浪费时间了。哈哈。
【在 A*****8 的大作中提到】
: http://online.wsj.com/article/SB1000142405311190363560457647585
: An influential outside panel called Friday for a broad overhaul of U.S.
: medical-device regulation, saying the Food and Drug Administration should
: give more intense scrutiny to thousands of devices that currently receive
: only a quick review before going on the market.
: If the FDA follows the advice of the Institute of Medicine committee, it
: could lead to the some of the biggest changes in decades in the system that
: decides how thousands of products ranging from artificial joints to heart-
: surgery devices reach U.S. patients. The sweeping nature of the
: recommendations appeared to take many by surprise.
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