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browse by categories     Audio Conference Archive     Audio Conferences     Past Conference Documentation     Webinar Archive     Webinars     Workshops product FDA 510(k) Process for Medical Device Companies This product was added to our catalog on Wednesday 20 May, 2009. Item #: Price:  $395.00    Product description 90 Minute Webinar Recording Speaker Heather Rosecrans Director of 510(k) Staff, Office of Device Evaluation/Center for Devices and Radiological Health, FDA A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least safe and effective. It provides a regulatory pathway for many products to enter the market by showing "substantial equivalence" to an already marketed product, typically without the need for clinical trials. This webinar will discuss the 510(k) process from an FDA perspective: When is a 510(k) necessary?;Review Process and considerations;FDA perspective on successful submissions Cost The cost to purchase the video recording is $395. Once your order is processed you will shipped a copy of the video file on flash drive. The video comes in windows media format and can easily be played on your computer.

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