| Description |
Description
The 510(k) submission process is the preferred method for obtaining marketing clearance for medical devices in the U.S.
In order to market a medical device in the U.S., manufacturers (foreign or domestic) must go through one of two evaluation processes stipulated by the U. S. FDA.
* Pre-market Notification, 510(k), unless exempt.
* Pre-market Approval (PMA), a much more involved, costly and time-consuming process.
Wherever justified, the 510(k) submission process is the preferred method for obtaining marketing clearance in the U.S. But how is this decision arrived at? If the 510(k) route is justified, what is involved? What is the sequence of events? What’s included? What is the desired format?
This seminar offers a detailed understanding of the 510(k) submission process, including the three types of 510(k)s and what’s involved in each; expected time frames, the post-submission review process, and the ‘give-and-take’ necessary for success.
Areas Covered in the seminar:
* U.S. FDA Class I, II, and III products.
* 510(k) determination - new and substantially modified.
* Three types of 510(k)s and which is justified.
* The importance of the "Intended Use" statement.
* How to locate predicate devices?
* Important considerations for choosing the predicate device(s) for the 510(k).
* Risk Analysis; Software considerations / reporting.
* What to include, what to hold in abeyance?
* The 510(k) and the DHF files.
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