The FDA Medical Device Pre-Submission program is intended for companies to use in order to obtain FDA feedback on future applications prior to their submission. The applications include Investigational Device Exemptions (IDEs), Premarket Approvals (PMAs), Humanitarian Device Exemptions (HDEs), and Premarket Notifications (510(k)s). This program allows the FDA to provide advice to applicants who are developing clinical and nonclinical testing protocols which are submitted with the company’s application. The program also allows the FDA to work with applicants from medical device concept to market. This web seminar will provide learners with information about how to prepare for and conduct various FDA meetings, specifically addressing the types of applications that companies file with the FDA.
- Navigate the FDA Pre-Submission program
- Describe the various FDA Pre-Submission meetings
- Prepare an FDA Pre-Submission package
- Prepare for and conduct FDA meetings
- Regulatory Affairs Personnel
- Quality Assurance Personnel
- Clinical Personnel
- Research Personnel
- Personnel who require a general understanding of the FDA's Pre-Submission program
Albert A. Ghignone, M.S., R.A.C.
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Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 3 hours (0.3 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-14-044-L01-P. Released: 3/14.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.