Why not use abbreviated 510k submissions?

[regfocus]

Hello,

If the manufacturer use abbreviated 510k submissions, should they submit testing data to FDA to claim standards they comply with? Can they claim they will do the tests required by FDA in the future after getting 510k approval?

Why most of the manufacturer do not go to abbreviated 510k?

 

[Ronen E]

Hello,

If the manufacturer use abbreviated 510k submissions, should they submit testing data to FDA to claim standards they comply with? Can they claim they will do the tests required by FDA in the future after getting 510k approval?

Why most of the manufacturer do not go to abbreviated 510k?

Lots of answers regarding abbreviated 510k submissions.

In my experience abbreviated 510k submissions don't save a lot of work, time or cost. That's why they're not used so often.

 

[J0anne]

Ronen is correct and the FDA will tell you that the term 'abbreviated' is misleading.