Company: PFSA
Filing Date: 2025-09-17
Form Type: S-1/A
Source: 0001213900-25-088333
Chunk: 51

Company: Profusa, Inc.
Filing Date: 2025-09-17
Form: S-1/A
Chunk 51
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 to restrictions or withdrawal from the market. Our products, if cleared or approved, would be subject to extensive regulation as medical devices in the United States and elsewhere, including by the FDA and its foreign counterparts. Any product for which we obtain marketing approval, clearance or authorization (and the activities related to its production, distribution, and promotion, sale, and marketing) will be subject to continual review and periodic inspections by the FDA and other regulatory bodies, which may include inspection of our manufacturing processes, complaint handling and adverse event reporting, post -approvalclinical data and promotional activities for such product. The FDA’s Medical Device Reporting, or MDR, regulations require that we report to the FDA any incident in which our product may have caused or contributed to a death or serious injury, or in which our product malfunctioned and, if the malfunction were to recur, it would likely cause or contribute to a death or serious injury. In addition, government regulations specific to medical devices are wide ranging and govern, among other things: •product design, development, manufacture, and release; •laboratory and clinical testing, labeling, packaging, storage and distribution; 30 •product safety and efficacy; •premarketing clearance or approval; •record keeping; •product marketing, promotion and advertising, sales and distribution; •post -marketingsurveillance, including reporting of deaths or serious injuries and recalls and correction and removals; •post -marketapproval studies; and •product import and export. If the FDA determines that there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, the agency may issue a cease distribution and notification order and a mandatory recall order. We may also decide to recall a product voluntarily if we find a material deficiency, including unacceptable risks to health, manufacturing defects, design errors, component failures, labeling defects, or other issues. Recalls of our products could divert the attention of our management and have an adverse effect on our reputation, financial condition, and operating results. We and certain of our suppliers are also required to comply with the FDA’s Quality System Regulation, or QSR, and other regulations which cover the methods and documentation of the design, testing, production, control, selection and oversight of suppliers or contractors, quality assurance, labeling, packaging, storage, complaint handling, shipping and servicing of our products. The FDA may enforce the QSR through announced (through prior notification) or unannounced inspections. Compliance with ongoing regulatory requirements can be complex, expensive and time -consuming. Failure