Which can be considered a long-term consequence of insufficient evidence in regulatory submissions?

In the context of regulatory submissions, insufficient evidence to support the safety, efficacy, or quality of a medical device can lead to significant long-term consequences for a manufacturer. One of the primary repercussions is the possibility of legal actions against the company. If a device is found to be ineffective or harmful due to the lack of substantiated evidence, it can lead to lawsuits from consumers, healthcare providers, or regulatory entities.

These legal actions may stem from claims of misrepresentation, product liability, or negligence, especially if patient harm or adverse events are linked to the inadequately supported device. The legal pressures not only pose financial risk but can also severely damage the manufacturer's reputation and relationship with stakeholders, affecting their ability to operate in the market effectively.

In contrast, options such as increased trust in the manufacturer or higher customer engagement are unlikely outcomes of insufficient evidence. These typically arise from robust, transparent regulatory submissions and positive product performance. Similarly, enhanced research collaborations usually depend on a manufacturer’s credibility and proven track record in the industry rather than on a foundation of insufficient evidence. Thus, the long-term consequence linked to insufficient evidence in regulatory submissions is primarily the increased risk of legal actions.