Company: INGN
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000950170-25-029993
Chunk: 196

Company: Inogen Inc
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1A
Chunk 196
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 pre-market approval application. The FDA requires every manufacturer to make this determination in the first instance, but the FDA may review and disagree with any manufacturer’s decision. The FDA may not agree with our decisions regarding whether new clearances or approvals are necessary. We have modified some of our 510(k) cleared products and have determined that in certain instances new 510(k) clearances or pre-market approval are not required. We may make similar determinations regarding modifications to our 510(k) products in the future. If the FDA disagrees with our determinations and requires us to submit new 510(k) pre-market notifications or pre-market approval for modifications to our previously cleared products for which we have concluded that new clearances or approvals are unnecessary, we may be required to cease marketing and/or to recall the modified product until we obtain clearance or approval, and we may be subject to significant regulatory penalties or fines. 

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If we fail to comply with FDA or state regulatory requirements, we can be subject to enforcement action. 

Even after we have obtained regulatory clearance or approval to market a product, we have ongoing responsibilities under FDA regulations. The FDA and state authorities have broad enforcement powers. Our failure to comply with applicable regulatory requirements could result in enforcement action by the FDA or state agencies, which may include any of the following sanctions: 

•adverse publicity, warning letters, fines, injunctions, consent decrees and civil penalties; 

•recalls, import detentions, termination of distribution, or seizure of our products; 

•operating restrictions or partial suspension or total shutdown of production; 

•delays in the introduction of products into the market; 

•refusal to grant our requests for future 510(k) clearances or approvals of new products, new intended uses, or modifications to existing products; 

•withdrawals or suspensions of current 510(k) clearances or approvals, resulting in prohibitions on sales of our products; and 

•criminal prosecution. 

Any of these sanctions could result in higher than anticipated costs or lower than anticipated sales and have a material adverse effect on our reputation, business, results of operations and financial condition. 

A recall of our products, either voluntarily or at the direction of the FDA or another governmental authority, or the discovery of serious safety issues with our products that leads to corrective actions, could have a significant adverse effect on us. 

The FDA and similar foreign governmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design