Pre-Submission/Q-Sub for Medical Devices
Grace Powers is an independent regulatory affairs consultant. She founded Powers Regulatory Consulting in 2015 to help clients with regulatory strategies and submissions. Her clients have included universities, investors, start-ups and mid-size medical device companies. She has fifteen years of industry experience in medical devices including research and development. She has previously worked at Brookhaven Medical, Bard Medical, CardioMEMS and Novoste, all in the Atlanta area.
She has leadership experience with managing regulatory affairs responsibilities related to all pre- and post-marketing regulatory activities and submissions. Her RA submission experience includes 510(k), Pre-Submissions, IDE, PMA, EU Technical Files and Design Dossiers. She has also managed an International RA team which including Canadian licensing, TGA, Japan, China, Russia, Latin America, and other country submissions. Grace holds a BE in Biomedical Engineering from Vanderbilt University, an MS in Biomedical Engineering from UCLA and an MBA from Georgia Tech. She is RAC US, RAC Europe, and RAC Global certified.
This webinar will discuss all aspects of the US FDA Pre-Submission process. This webinar will review when a Pre-submission may be appropriate for a company or product. It will include a review of the guidance document. The types of Pre-submissions will also be reviewed including those for IDE applications, study risk determinations, Pre-Sub for a 510(k), Pre-Sub for a PMA and Pre-Sub for an IVD. The content needs for the various Pre-Sub types will also be explored. Questions that are appropriate for FDA Pre-Submissions will be discussed in great detail including examples of good and not so good questions for FDA. The e-copy required for Pre-Submissions will be reviewed as well as tips of the logistics of in-person meetings at FDA. Overall the webinar will include all the background needed to submit a Pre-Submission.
US Food and Drug Administration Pre-Submission (Q-Subs)
- Understand the USA FDA Pre-submission process
- Understand the types of Pre-Subs
- Understand the various types of FDA meetings
- Understand the logistics of an in-person FDA meeting
- Pre-Sub for a 510(k)
- Pre-Sub for a PMA
- Pre-Sub for an IVD
Course Level - Intermediate
Who Should Attend
- Compliance Officers
- Regulatory Affairs - all levels
- Clinical Affairs - all levels
- Quality Assurance - all levels
- Quality Engineering - all levels
- Medical Scientists
- R&D - all levels
- Anyone interested in the FDA Pre-submission process
Why Should Attend
- What is a Pre-Submission?
- When is a Pre-Submission appropriate for my company or product?
- What types of questions are right to ask for FDA Pre-Submissions
- Complete Background and Preparation required to submit Pre-Submissions
- How will I get my feedback?