What did the clinical trials show?
We will not discuss the results of the clinical trials performed for the 510(k) submission. We can make no claims that the device is safe or effective until we have FDA approval. Certainly, we believed the results were appropriate for the purpose of our 510(k) submission. It’s worth noting that most 510(k)s require no clinical trials. However, the FDA can require a lot of data. This is a gray area in FDA regulations.
How long did you expect the 510(k) process to take?
Here is the regulation regarding the 90 days, for reference:
“Sec. 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use which meets any of the following criteria…”
What did the FDA’s letter to MIMvista say?
Here is the relevant portion of the NSE letter:
“We have determined the device is not substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to any device which has been reclassified into class I (General Controls) or class II (Special Controls).
This decision is based on the fact that your device has a new indication for displaying medical images for diagnostic use on a mobile/portable device…that alters the diagnostic effect, impacting safety and effectiveness, and is therefore a new intended use.
Furthermore, your device has new technological characteristics that could adversely affect safety and effectiveness and raise new types of safety and effectiveness questions…
Therefore, this device is classified by statute into class III (Premarket Approval), under Section 513(f) of the Federal Food, Drug, and Cosmetic Act (Act).”
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