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

Business, Finance, Economics, Accounting, Operations Management, Computer Science, Electrical Engineering, Mechanical Engineering, Civil Engineering, Chemical Engineering, Algebra, Precalculus, Statistics and Probabilty, Advanced Math, Physics, Chemistry, Biology, Nursing, Psychology, Certifications, Tests, Prep, and more.
Post Reply
answerhappygod
Site Admin
Posts: 899603
Joined: Mon Aug 02, 2021 8:13 am

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

Post by answerhappygod »

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.
Join a community of subject matter experts. Register for FREE to view solutions, replies, and use search function. Request answer by replying!
Post Reply