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Page 1 of 3 CVS/Earmark STR Quality Assurance Program Medical Device POTENTIAL NEW ITEM (PNI) Product Submission Profile Form (Fill out completely) *Incomplete document submissions affect turnaround
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What is pni med device submission?
PNI med device submission is a process where manufacturers submit information about their medical devices to regulatory authorities for approval or clearance before marketing or selling.
Who is required to file pni med device submission?
Manufacturers of medical devices are required to file PNI med device submissions.
How to fill out pni med device submission?
PNI med device submissions are typically filled out online through a regulatory authority's electronic portal or submission system.
What is the purpose of pni med device submission?
The purpose of PNI med device submission is to ensure that medical devices meet regulatory requirements for safety and effectiveness before being marketed or sold.
What information must be reported on pni med device submission?
Information such as device design, manufacturing process, intended use, risk assessment, clinical data, and labeling must be reported on PNI med device submission.
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