FHI assists medical device manufacturers, distributors and importers in responding to and resolving medical device law issues relating to:
- Premarket Approval Applications (PMAs), Premarket Notifications (510(k)s) and Investigational Device Exemption (IDE) Applications
- Quality System Regulation (QSR) and the Medical Device Reporting Regulation MDR)
- FDA establishment inspections
- Importation and exportation of medical devices
- FDA 483s and Warning Letters
- Recalls
- Injunctions
- Seizures
- Advice on labeling, advertising and promotion of medical devices
- Establishment registration and medical device listing requirements
- Representation in rulemaking, policy, enforcement and litigation
- Guidance, laws and regulations related to the manufacture and use of radiation emitting products
- Information for mammography facility personnel, inspectors and consumers
- Counsel on proposed performance standards for electronic products
- Information on whole body computed tomography (CT) scanning.
For more information, please contact Christine M. Humphrey, Esq. at chumphrey@fuerstlaw.com.
