Definition of Premarket. Meaning of Premarket. Synonyms of Premarket

- as a class II device subject to premarket notification, or to require the device manufacturer to undergo the premarket authorization process and prove...
- A premarket tobacco application (PMTA) is an application that must be reviewed and approved by the Food and Drug Administration before a new tobacco product...
- Option 510(k) FDA Premarket Notification K881017 ADAC LABORATORIES". fda.report. Retrieved 2023-03-29. "Viewpoint 510(k) FDA Premarket Notification K882205...
- clinical trials. The third regulatory pathway for new medical devices is the Premarket Approval process (PMA), described below, which is similar to the pathway...
- is withdrawing the proposed rule and proposed order to call for PMAs [premarket approvals] for CES devices. FDA plans to issue a proposed order in the...
- approval by a process known as 510(k) premarket notification instead of entering the market through a more stringent premarket approval process. The company has...
- devices in the United States are required to conduct clinical trials for premarket approval. Device trials may compare a new device to an established therapy...
- "Premarket Approval (PMA)". "Premarket Approval (PMA)". "Premarket Approval (PMA)". "Premarket Approval (PMA)". "Premarket Approval (PMA)". "Premarket...
- prosecution. In 2004, the FDA reversed a federal policy, arguing that FDA premarket approval overrides most claims for damages under state law for medical...
- 800 series are for medical devices: 803 Medical device reporting 814 Premarket approval of medical devices 820 et seq. Quality system regulations (analogous...