More PMAs Would Results From FDA’s Classification Proposal, AdvaMed Warns-thegraysheet: The FDA’s proposal to amend and clarify its regulations on classification and re-classification of medical devices could fundamentally change the classification process and result in more devices having to undergo the more stringent PMA review, warns medtech industry association AdvaMed. In particular, the propose rule, if implemented in its current form, would substantially rewrite the definition of high risk, class III devices and move more products from 510(k) to PMA standards, AdvaMed argues.
