Medical Devices and the FDA Reauthorization Act of 2017 - Webinar Recording/Transcript

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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.

Devicemakers, contract manufacturers, device specification develops and others subject to FDA device inspection, including specific job titles such as:

  • Quality personnel
  • Operations personnel
  • Regulatory personnel
  • Compliance personnel
  • Legal counsel

Jessica Ringel Esq. is Counsel in the Washington offices of King & Spalding LLP where she participates in the FDA and Life Sciences practice. She is an expert on post-market inspections, responses to Forms 483s and Warning Letters, recalls and other enforcement actions. She regularly conducts due diligence reviews for drug and device manufacturers, private equity firms, and lenders in connection with mergers, acquisitions, investments, and other financial transactions.