510k

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.

Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.

How to Submit a 510K

How to Submit a 510K

Three types of Premarket Notifications can be submitted to the Food and Drug Administration (FDA) Traditional, abbreviated, and special 510Ks. The traditional 510K program is utilized to seek marketing authorization for any device. When submitting a 510K there is not a form to submit however submission requirements can be found under 21 CFR part 807.

Label Changes and the 510k

Label Changes and the 510k

Submitting a 510k for a medical device can be a long and confusing process. When a 510k is submitted the device itself...

510K Submission Tips

510K Submission Tips

‌  Registering a new device with the FDA can be tricky. The first step is to choose what pathway to follow for...

Choosing a Predicate Device

Choosing a Predicate Device

‌  One of the critical choices for staying on the premarket notification, the 510(k) pathway, is choosing the...

The Types of 510(k) Submissions

The Types of 510(k) Submissions

For the most part, everyone in the medical device industry is familiar with the term “510(k)”, but not many people...

Regulatory Change Assessment

Regulatory Change Assessment

Making a change to the design or the manufacturing process of your product that is already out in the field? You have...

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