510(k) Program Comparison 

Chart
This is an extra resource to go along with the original article: 
Special 510(k) vs. Abbreviated 510(k) vs. Traditional 510(k):
Which FDA Program Applies to My Device?

Pros Cons Best suited for 

Faster than the PMA • Longer review Manufacturers who 

Traditional
(Premarket period. can demonstrate 
510(k) 
Approval) process. • Must have a substantial
predicate device to equivalence with a 
compare to. predicate device. 

Abbreviated Does not require the The longest review Manufacturers

510(k) manufacturer to period. Past records who perhaps
have a predicate show it taking about can’t get find a
device available. 50% more time than predicate device,
You can use Traditional. but can 
performance criteria/ demonstrate
standards instead. equivalence with 
standards.

Manufacturers
Special Can be a Only possible if the
who are updating
510(k)  comparatively short device modification
review period. a device (labeling,
requires just one
design,
technical discipline to
manufacturing
review it.
technique…) and
will use their own
device as the
predicate.

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