Almost There: Safety and Performance Pathway Option for 510(k) Submissions

On 1/22/2019, the FDA posted their final guidance describing the Safety and Performance Pathway option for 510(k) submissions. This pathway gives another option for medical devices that have technological differences but that are still as safe and effective as a legally marketed predicate device. Typically, in these situations, the new device manufacturer would have to

Combined use diagnostic instruments and the FDA’s thoughts

The FDA has recently released a draft guidance entitled “Molecular Diagnostic Instruments with Combined Functions.” The recommendations display intent to mitigate interference in molecular diagnostic instruments with combined FDA approved device functions and functions in which FDA approval is not required, and furthermore prevent confusion for the end user. While following the guideline should serve