Company: PFSA
Filing Date: 2025-09-17
Form Type: S-1/A
Source: 0001213900-25-088333
Chunk: 190

Company: Profusa, Inc.
Filing Date: 2025-09-17
Form: S-1/A
Chunk 190
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 by which the manufacturer monitors the manufacturing process and maintains records that show compliance with FDA regulations and the manufacturer’s written specifications and procedures relating to the devices. The QSR also requires, among other things, maintenance of records and certain documentation, a device master file, device history file, and complaint files. QSR compliance is necessary to receive and maintain FDA clearance or approval to market new and existing products. As a manufacturer, we are subject to periodic scheduled or unscheduled audits or inspections by the FDA. Our failure to maintain compliance with the QSR requirements could result in the shut -downof, or restrictions on, our manufacturing operations and the recall or seizure of our products, which would have a material adverse effect on our business. The discovery of previously unknown problems with any of our products, including unanticipated adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance or off -labelby a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls. The FDA has broad regulatory compliance and enforcement powers. If the FDA determines that we failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions: •FDA untitled letters, FDA Form 483s, FDA warning letters, it has come to our attention letters, fines, injunctions, consent decrees and civil penalties; •unanticipated expenditures to address or defend such actions; •customer notifications or repair, replacement, refunds, recall, detention or seizure of our products; •recall, detention or seizure of our products; •operating restrictions, partial suspension or total shutdown of production; •refusing or delaying our requests for regulatory approvals or clearances of new products or modified products; •withdrawing of 510(k) clearances or PMA approvals that have already been granted; •refusal to grant export approval for our products; or •criminal prosecution. The FDA can also publish Safety Communications or Letters to Health Care Providers when the agency becomes aware of new issues involving a specific product or, or more broadly, a product family. These communications are posted on the FDA’s website and describe the FDA’s analysis of a current issue and provide specific regulatory approaches and clinical recommendations for patient management. 124 Healthcare Laws Coverage and Reimbursement Our ability to commercialize any products successfully will depend in part on the extent to which coverage and adequate reimbursement for our product