Published on Jun 20, 2012 by reperikpaulsen
Rep. Erik Paulsen (MN-03) took to the
House floor in support the a package of FDA reforms. Reforms in this package
will make the device approval process more transparent, more consistent, and
more predictable. Specifically a provision proposed by Rep. Paulsen to
streamline the third party review process will free up valuable resources at
the FDA.
www.paulsen.house.gov
Comment by explanthis 6/22/12 (FiDA blog)
Patients are harmed and placed in medical and legal purgatory
because Congress has directed the FDA to approve implanted medical devices
without clinical testing 510(k) with no warranty or post-market independent
data or UDI so that consumers can select a safe device. Representative Paulsen has
personal financial investments in medical device companies and is a cheerleader
for the industry. He is not impartial and he is aware of FDA Adverse Event
#5009052.
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