Safety and Performance Based 510(k)
The Safety and Performance Based Pathway is generally preferred for well-understood medical devices ...
Substantial Equivalence
In FDA Substantial equivalence means to demonstrate a new device to be marketed is safe and effectiv...
Abbreviated 510 k
Abbreviated 510 k The medical devices for which the 510 k or premarket notification is requir...
510 k Summary or Statement
510 k Summary or Statement 510 k Summary or Statement is part of the 510 k file of a m...
Traditional 510 k
Traditional 510 k The Traditional 510 k is one among the three types of the 510 k in t...
CMR or Endocrine Disrupting Substances in the Medical Devices
According to regulation no. (EC) 1272/ 2008, Annex VI part 3, the substances that are carcino...