For the most part, everyone in the medical device industry is familiar with the term “510(k)”, but not many people know that there are three different types of the premarket notification. The following are the different types of 510(k)’s a firm can submit: Traditional, special, and abbreviated. Each 510(k) is a premarket notification, which if cleared, grants the firm permission by the FDA to market the device; but each one has different benefits and processes that medical device firms can take advantage of...

1. The Types of 510(k) Submissions
By: Madison Wheeler
For the most part, everyone in the medical device industry is familiar with the term “510(k)”, but not
many people know that there arethreedifferent types ofthe premarket notification. The following are the
different types of510(k)’s a firm can submit:Traditional,special, and abbreviated.Each 510(k) is a
premarket notification, which ifcleared,grants the firm permission by the FDA to market the device;but
each one has different benefits and processes that medical device firms can take advantage of.
The first, and most common, type is the traditional 510(k). The traditional 510(k) is used to show
substantial equivalence with a predicatedevice already on the market concerning indications for use and
technological characteristics. Ifyou have a predicate devicepicked out, there areno mandated special
circumstances or conditions to submit a traditional 510(k).There is also no special “form”to complete, a
traditional 510(k) is simply a submission of all the information required under21 CFR807 .87.1
A special 510(k) is commonly used when you want to make a change or modification to a device already
on the market. The special program,established by the agency in 1998, was aimed at creating an efficient
review process for device changes subject to 510(k) submission requirements. Fora special 510(k),
summary information resulting from the design control process can serve as the basis for substantial
equivalence, along with the required information in 21 CFR 807.87. Information necessary for a special
510(k) submission includes:identifying and analyzing any risks associated with the change, the
verification/validation methods with results, and the associated acceptance criteria.In general, a design
controls program compliant with 21 CFR820.30 should providesufficientinformation for a special 510(k)
submission. The average time for a Special review is roughly 50%ofthe Traditional review time;
additionally, ifthe agency determines that the Special 510(k) is not appropriate, it will notify the
submitter and convert it to a traditional.2
Finally, an abbreviated 510(k) is used for showing substantial equivalence to a recognizedstandard,
special control, orguidance using a declaration ofconformity. Despite the name, this type ofsubmissionis
no shorter or easier than the traditional submission and typically takes twice as long for the agency to
review. In an abbreviatedsubmission,manufacturers prove substantial equivalence based on the use of
guidance documents ordeclarations ofconformity to recognized standards instead ofa predicatedevice to
facilitate the FDA’s review.3
The regulatory landscape for medical devices can be very confusing;and the variety ofoptions FDA
provides as a means ofadding clarity can sometimes make it even more complex for manufacturers. Ifyou
need help deciding which 510(k) submission is right for yourdevice, EMMA International has a team of
experts ready to help. Give us a call at 248-987-4497 or email info@emmainternational.com to get
connectedwith our regulatory experts.
1 FDA(September 2019) Howto Preparea Traditional510(k) retrieved on08/26/2020from: https://www.fda.gov/medical-devices/premarket-
notification-510k/how-prepare-traditional-510k
2 FDA(May 2020) How to Prepare a Special510(k) retrievedon 08/26/2020 from: https://www.fda.gov/medical-devices/premarket-
notification-510k/how-prepare-special-510k
3 FDA(January 2019) How toPrepareanAbbreviated 510(k) retrieved on 08/26/2020 from: https://www.fda.gov/medical-devices/premarket-
notification-510k/how-prepare-abbreviated-510k