Medical Devices and the FDA Reauthorization Act of 2017 - Webinar Recording/Transcript
Medical Devices and the FDA Reauthorization Act of 2017: What YOU Need to Know about FDARA
Many devicemakers are viewing changes in the FDA Reauthorization Act of 2017 (FDARA) as a good thing, but the devil is in the details — and some of those details start taking effect next month. It’s time you got up to speed.
FDAnews has reached out to a prominent member of the FDA Bar, Jessica Ringel Esq. of King & Spalding LLP’s Washington office, for explanations and insights.
Over 90 fast-paced minutes, Ms. Ringel will bring you current on:
- User fees: Changes you can expect in the fees your company pays for premarket submissions
- FDA Inspections: Improvements anticipated in the inspections process
- Certificates to Foreign Governments: How transparency in issuance and denials will increase
- Pediatric device development: Specific FDA efforts to stimulate innovation in this area
- What’s to come: New guidances, rules and reports anticipated from the agency in coming years
- And much more!
FDARA deadlines start hitting next month. Every devicemaker needs to know how the changes will cause benefit — or harm. Discover the details with one of Washington’s most knowledgeable presenters.