Respond to this discussion post in a positive way in 5-7 sentences What I want to say is that the FDA issued a guidance
Posted: Tue Feb 15, 2022 3:49 pm
Respond to this discussion post in a positive way in 5-7
sentences
What I want to say is that the FDA issued a guidance document
for breakthrough device designation, and at the same time FDA
opened a new path for medical device manufacturers - the Safer
Technologies Program (STeP), to encourage those who have made
progress in safety Significant advances, first-time safety
innovations, enter the market early. Central to the FDA's vision
for this launch of STeP is to support important safety advancements
in medical devices that help improve patients' quality of life and
advance public health missions. The STeP can be used in devices
that do not meet the current program criteria for what is
considered a breakthrough device, but through innovative design has
the potential to be safer than currently available alternative
treatments or diagnostics. The current Breakthrough Devices Program
is designed to advance the development of innovative devices and
help patients get more timely and more effective products to
diagnose, or treat life-threatening or irreversibly debilitating
diseases or conditions. These devices provide a new method of
treating or diagnosing a disease or condition, have significant
advantages over existing theranostic alternatives, or provide
another public health benefit.
sentences
What I want to say is that the FDA issued a guidance document
for breakthrough device designation, and at the same time FDA
opened a new path for medical device manufacturers - the Safer
Technologies Program (STeP), to encourage those who have made
progress in safety Significant advances, first-time safety
innovations, enter the market early. Central to the FDA's vision
for this launch of STeP is to support important safety advancements
in medical devices that help improve patients' quality of life and
advance public health missions. The STeP can be used in devices
that do not meet the current program criteria for what is
considered a breakthrough device, but through innovative design has
the potential to be safer than currently available alternative
treatments or diagnostics. The current Breakthrough Devices Program
is designed to advance the development of innovative devices and
help patients get more timely and more effective products to
diagnose, or treat life-threatening or irreversibly debilitating
diseases or conditions. These devices provide a new method of
treating or diagnosing a disease or condition, have significant
advantages over existing theranostic alternatives, or provide
another public health benefit.