Respond to this discussion post in 5- 7 sentences in a positive way One of the CDRH’s accomplishments was their commitme

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answerhappygod
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Respond to this discussion post in 5- 7 sentences in a positive way One of the CDRH’s accomplishments was their commitme

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Respond to this discussion post in 5- 7 sentences in a positive
way
One of the CDRH’s accomplishments was their commitment to
further developing the use of real-world data (RWD) and evidence
(RWE) in medical device manufacturing and regulation. RWE allows
sponsors to leverage data generated outside of a clinical setting,
which can strengthen the understanding of different potential
device uses in real-world situations. Data obtained from clinical
trials is important, but due to the specific qualifying criteria to
participate, this data is often specific in its application to a
certain population. RWD is collected from a wide range of people,
of varying age, ethnicity, disease progression, etc. The CDRH has
provided funding for a national RWD evaluation system called NEST,
which encourages data sharing and analysis to allow medical
professions to make the best-informed decisions for their patients.
The CDRH has also expanded its use of RWE when making regulatory
decisions, which in turn means more device indications to improve
patient and public health. Clinical trials are very expensive, so
the use of RWD allows sponsors to leverage available data without
the usual resource costs. RWE is still not a broadly used strategy,
but by developing additional policies and guidance, both for
industry and FDA staff, the CDRH is attempting to make RWE use more
prevalent.
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