Biomedical Device
/ˌbaɪoʊˈmɛdɪkəl dɪˈvaɪs/
Definitions
- (n.) An instrument, apparatus, implement, machine, or related article intended for medical use to diagnose, cure, mitigate, treat, or prevent disease or other conditions, subject to regulation under medical device law.
The company must obtain FDA clearance before marketing its new biomedical device.
Forms
- biomedical device
- biomedical devices
Related terms
See also
Commentary
The term 'biomedical device' is broadly defined in medical device regulatory statutes and often overlaps with 'medical device'; care should be taken to align usage with applicable jurisdictional definitions.
This glossary is for general informational and educational purposes only. Definitions are jurisdiction-agnostic but reflect terminology and concepts primarily drawn from English and American legal traditions. Nothing herein constitutes legal advice or creates a lawyer-client relationship. Users should consult qualified counsel for advice on specific matters or jurisdictions.