In medical device liability, which party is primarily responsible for defects?

• A. Manufacturer liability for defects
• B. Clinician liability for improper use
• C. FDA regulation
• D. Risk disclosure and recall obligations

Answer: (A)

When a medical device is defective, the party primarily responsible is the manufacturer because the defect is a problem with the product itself, stemming from design, production, labeling, or testing decisions made by the company that brought the device to market. In many jurisdictions, this leads to product liability that can be strict, meaning the manufacturer is liable for harms caused by the defect regardless of fault, or negligent if they failed to meet the standard of care in bringing the device to market or in post-market surveillance.

Clinicians are liable for how they use devices or if they fail to follow proper instructions, but that liability concerns misuse or negligence in practice rather than a defect in the device itself. Regulation by the FDA governs approval, safety monitoring, and post-market actions, but regulatory compliance does not automatically assign fault for a defect. Recall obligations and risk disclosures are safety measures tied to addressing defects, yet the legal responsibility for the defect itself rests with the manufacturer.

So the best answer is that the manufacturer bears primary liability for defects.