Medical Devices and the FDA Reauthorization Act of 2017
What YOU Need to Know about FDARA

Thursday, July 26, 2018 · 1:30 p.m. - 3:00 p.m. EDT

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. 

Register now.

BONUS: Order the webinar plus audio recording/transcript or the 24/7 encore plus audio recording/transcript for $487, and receive a FREE copy of CDRH Reorganized: New Strategies for Devicemakers (retail value $397).

CDRH Reorganized: New Strategies for Devicemakers
Reorganization plans, which will evolve over the next couple of years, aim to streamline CDRH’s operations into two functional offices — regulatory programs and clinical evidence and analysis — with six device-specific offices under them. This means no more dealing with multiple levels of decisionmakers, crossed communication lines and delayed feedback from the agency. This report lets you know what to expect, how to take advantage of new opportunities and how to influence the direction of the new system.

Who Will Benefit

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

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Meet Your Presenter

Jessica Ringel Esq.

Counsel in the Washington offices
King & Spalding LLP

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.

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.

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