Company: INGN
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000950170-25-029993
Chunk: 194

Company: Inogen Inc
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1A
Chunk 194
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 federal and state laws or regulations can result in severe criminal, civil and administrative fines, penalties and sanctions, including debarment, suspension or exclusion from Medicare, Medicaid and other government reimbursement programs, any of which would have a material adverse effect on our business. 

Changes in healthcare laws and regulations and new interpretations of existing laws and regulations may affect permissible activities, the relative costs associated with doing business, and reimbursement amounts paid by federal, state and other third-party payors. There have been and will continue to be regulatory initiatives affecting our business and we cannot predict the extent to which future legislation and regulatory changes could have a material adverse effect on our business. 

We are subject to significant regulation by numerous government agencies, including the FDA. We cannot market or commercially distribute our products without obtaining and maintaining necessary regulatory clearances or approvals and such approvals may be revoked or revised if an agency like the FDA believes it necessary. 

Our products are medical devices subject to extensive regulation in the United States and in the foreign markets where we distribute our products. The FDA and other U.S. and foreign governmental agencies regulate, among other things, with respect to medical devices: 

•design, development and manufacturing; 

•testing, labeling, content and language of instructions for use and storage; 

•clinical trials; 

•product safety; 

•marketing, sales and distribution; 

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•pre-market clearance and approval; 

•record keeping; 

•advertising and promotion; 

•recalls and field safety corrective actions; 

•post-market safety reporting, including reporting of deaths or serious injuries and malfunctions that, if they were to recur, would be likely to lead to death or serious injury; 

•post-market approval studies; and 

•product import and export. 

Before we can market or sell a medical device in the United States, we must obtain 510(k) clearance, authorization under the De Novo process or approval of a pre-market approval application from the FDA, unless an exemption applies. In the 510(k) clearance process, the FDA must determine that a proposed device is “substantially equivalent” to a legally marketed predicate device in order to clear the proposed device for marketing. 

Our commercial products have received 510(k) clearance by the FDA. If the FDA requires us to go through a lengthier, more rigorous examination for future products or modifications to existing products than we had expected, our product introductions or modifications could be delayed or canceled, which, depending on the specific action, could cause the majority