This webinar is intended to demonstrate 510(k) contents and format including 510(k) processes in accordance with FDA’s eCopy and RTA policy so that your time, energy and financial resources can be effectively used to accelerate your 510(k) preparation, submission and clearance, potentially leading to saving millions.
In June, 2013, FDA has cleared 211 devices (510(k)s) under the 510(k) program. Among those, there were three abbreviated and 49 special 510(k)s. Among 49 specials, there is a 510(k), which was filed in the middle of the year 2011. For the special 510(k), it has taken almost two years. On the other hand, in June, 2010, 2011 and 2012, FDA cleared 243, 240 and 258 devices (510(k)s), respectively.
Although it is believed there are various factors contributing to those 510(k) clearances, it is imperative more than ever from our industry perspectives that the medical device manufacturers understand recent changes (hurdles and new requirements) and be able to prepare a 510(k) in a sufficiently adequate way to expedite the review process and successful clearance without delays.
In this webinar, speaker will discuss what and how to do with your 510(k) preparation and submission. In particular, the speaker will share what he has learned from his own experience and also based on his analysis of 510(k)s recently cleared including those in June, 2013.
Areas to be Covered:
Statute(s) and regulations
Regulatory requirements for 510(k)s
Device classification and predicates
When 510(k)s are required
Demonstrating substantial equivalence
Recent 510(k) changes and requirements including e-Copy and RTA policy
Regulatory requirements for products
How to address and present performance data and/or clinical data in a succinct, comprehensive manner.
How to respond to FDA’s request of additional information.
How to resolve different opinions between the submitter and FDA reviewer(s)
Who will Benefit:
Anyone interested in 510(k) matters