Medical Device Law
/ˈmɛdɪkəl dɪˈvaɪs lɔː/
Definitions
- (n.) The body of law governing the regulation, approval, manufacturing, marketing, and post-market surveillance of medical devices.
Medical device law ensures that new surgical instruments meet strict safety standards before they reach consumers.
- (n.) Regulatory framework that oversees compliance of medical devices with health and safety standards imposed by governmental agencies.
Companies must navigate complex medical device law to gain authorization from regulatory bodies like the FDA.
Forms
- medical device law
Related terms
See also
Commentary
Often involves both statutory and administrative regulations; critical to specify jurisdiction due to variation in legal regimes.
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.