s*********e
发帖数: 884 | 1 Source:
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHInnovation/
What is the Medical Device Innovation Initiative?
The CDRH Medical Device Innovation Initiative proposes actions that CDRH
could take to help accelerate and reduce the cost of development and
regulatory evaluation of innovative medical devices safely and based on
sound science.
How will the Medical Device Innovation Initiative promote and support
investment in new technology?
Lack of a transparent, predictable path to market is a significant barrier
to innovation. Without a predictable path to market, it is difficult for
innovating companies to attract investors and estimate costs. As part of
this Medical Device Innovation Initiative, CDRH is proposing additional
actions the Center could take to encourage innovation, streamline regulatory
and scientific device evaluation, and expedite the delivery of novel,
important, safe and effective innovative medical devices to patients.
What kinds of devices may be considered for the Innovation Pathway?
These devices would be radically different from any legally marketed medical
device in the United States in their underlying technology or manner of use
, and be designed to meet at least one of the following criteria:
significantly improve upon currently available treatments or diagnostics for
life-threatening or irreversibly debilitating diseases or conditions;
treat or diagnose a disease or condition for which no approved alternative
treatment or means of diagnosis exists;
address an unmet public health need as identified by the Council on Medical
Device Innovation (CMDI); or
address an issue relevant to national security such as vaccine development
and medical counter measures.
Will the Innovation Pathway shorten the review process?
The Innovation Pathway includes a number of key features designed to
minimize delays that can occur when pioneering devices raise novel and
challenging scientific questions. By front-loading critical aspects, such as
identifying appropriate clinical endpoints and key scientific questions,
and seeking advice from external experts, CDRH can provide a more timely and
efficient regulatory review process. Given significant senior management
involvement and review team involvement throughout the device development
process, CDRH proposes a review time frame of 150 days – which is
approximately half the time it takes to review most PMAs.
Enrollment in the Innovation Pathway would not change the scientific or
regulatory standards that CDRH would use to evaluate device submissions and
determine their appropriateness for marketing. Instead, the Innovation
Pathway would recognize the challenges of developing transformative
innovative devices and increases the commitment of Center resources to their
development and evaluation.
note: there is more information on FDA's website. | l*****f
发帖数: 359 | 2 good to know :P
【在 s*********e 的大作中提到】
: Source:
: http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHInnovation/
: What is the Medical Device Innovation Initiative?
: The CDRH Medical Device Innovation Initiative proposes actions that CDRH
: could take to help accelerate and reduce the cost of development and
: regulatory evaluation of innovative medical devices safely and based on
: sound science.
: How will the Medical Device Innovation Initiative promote and support
: investment in new technology?
: Lack of a transparent, predictable path to market is a significant barrier
| s**********8
发帖数: 25265 | 3 this very new.
published in Q1 of this year.
it's very good to know and i will read through.
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHInnovation/ | l*****f
发帖数: 359 | 4 这么好啊,俺也要好好学习
【在 s**********8 的大作中提到】
: this very new.
: published in Q1 of this year.
: it's very good to know and i will read through.
: http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHInnovation/
| h********e
发帖数: 2823 | 5 Glad to know it was of some use to you :)
I actually found a video on this on youtube:
http://www.youtube.com/watch?v=bN36QVZhMv0
【在 s**********8 的大作中提到】
: this very new.
: published in Q1 of this year.
: it's very good to know and i will read through.
: http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHInnovation/
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