|
Activity Number:
|
408
|
|
Type:
|
Topic Contributed
|
|
Date/Time:
|
Wednesday, August 1, 2007 : 10:30 AM to 12:20 PM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #309832 |
|
Title:
|
Pre-PMA Meetings with the FDA in Medical Device Submissions
|
|
Author(s):
|
Greg Campbell and Gerry Gray and Lilly Yue*+
|
|
Companies:
|
Food and Drug Administration and Food and Drug Administration and Food and Drug Administration
|
|
Address:
|
1350 Piccard Dr., Rockville, MD, 20850,
|
|
Keywords:
|
Premarket application ; medical device statistics ; diagnostic product
|
|
Abstract:
|
Prior to submitting a premarket application (PMA) to FDA's Center for Devices and Radiological Health (CDRH), a sponsor for a medical device or diagnostic product may choose to have a "pre-PMA" meeting with CDRH staff. This meeting can serve both regulatory and scientific purposes; CDRH statisticians regard it as an opportunity to discuss statistical issues with their industry counterparts, to set forth expectations regarding the submission of data in electronic form, and to arrive at understandings regarding data analysis and reporting. This talk will describe some of the outcomes of pre-PMA meetings that we feel are mutually beneficial to the sponsor's and FDA's statistical staff.
|
