Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 215

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 215
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 This procedure allows a manufacturer whose novel
device is automatically classified into Class III to request classification of its medical device into Class I or Class II
on the basis that the device presents low or moderate risk, rather than requiring the submission and approval of a PMA application. A
medical device may be eligible for De Novo classification if the manufacturer first submitted a 510(k) premarket notification and
received a determination from the FDA that the device was not substantially equivalent or a manufacturer may request De Novo classification
directly without first submitting a 510(k) premarket notification to the FDA and receiving a not substantially equivalent determination.
The FDA is required to classify the device within 120 calendar days following receipt of the De Novo application, although in practice,
the FDA’s review may take significantly longer. During the pendency of the FDA’s review, the FDA may issue an additional information
letter, which places the De Novo request on hold and stops the review clock pending receipt of the additional information requested. In
the event the De Novo requestor does not provide the requested information within 180 calendar days, the FDA will consider the De
Novo request to be withdrawn. If the manufacturer seeks reclassification into Class II, the manufacturer must include a draft proposal
for special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the medical device. In addition,
the FDA may reject the De Novo request for classification if it identifies a legally marketed predicate device that would be appropriate
for a 510(k) or determines that the device is not low to moderate risk or that general controls would be inadequate to control the
risks and special controls cannot be developed. In the event the FDA determines the data and information submitted demonstrate that general
controls or general and special controls are adequate to provide reasonable assurance of safety and effectiveness, the FDA will grant
the De Novo request for classification. When the FDA grants a De Novo request for classification, the device is granted marketing authorization
and further can serve as a predicate for future devices of that type, through a 510(k) premarket notification.

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Clinical Trials

Clinical trials are almost
always required to support a PMA and are sometimes required to support a 510(k) submission. All clinical investigations of devices
to determine safety and effectiveness must be conducted in accordance with the FDA’s IDE regulations which govern investigational
device labeling, prohibit promotion of the investigational device, and specify an array of