What does the FDA require from manufacturers regarding device safety?

The FDA requires manufacturers to provide evidence that devices are safe and effective because this is central to the regulatory process for medical devices. Before a device can be marketed, manufacturers must submit data demonstrating that the device performs as intended and does not pose an unreasonable risk to patients or users. This evidence is typically submitted as part of premarket submissions, such as a 510(k) notification or a Premarket Approval (PMA) application, depending on the classification of the device.

Safety and effectiveness are assessed through rigorous clinical and non-clinical testing, and the FDA evaluates this data to ensure that the benefits of the device outweigh any potential risks. This requirement underscores the FDA's commitment to protecting public health by ensuring that medical devices on the market meet established safety and efficacy standards. Consequentially, manufacturers must invest in research and development to gather the necessary data prior to obtaining market clearance or approval.

The other options do not relate to the fundamental requirements set forth by the FDA for device safety. For example, annual financial reports pertain to corporate transparency and financial health, not to device safety. Proof of extensive advertising is also irrelevant, as the FDA's focus is on the device's performance and risk profile rather than marketing efforts. Customer testimonials and reviews cannot serve