Latest FDA Changes to the Process Bullet Proof 510k - 2017

  • Free
  • Published date: May 15, 2017
    • Fremont, One Dial-in One Attendee Price: US$150.00, United States

The Special and Abbreviated 510(k) methods were developed under the

"New 510(k) Paradigm" to help streamline the 510(k) review process.

Know the differences between the Traditional, Special and Abbreviated

Understand Substantial Equivalence and how it is applied
Who is required to submit the application to FDA

Who Will Benefit:
This course is appropriate to those involved in all aspects of the premarket

notification, i.e., 510(k) process on behalf of medical device and In Vitro

Diagnostic manufacturers.

Speaker Profile:
David R. Dills,Global Regulatory Affairs & Compliance Consultant currently

provides regulatory affairs and compliance consultative services for early-

stage and established Class I/II/III device, IVD, biopharmaceutical,

cosmetics and nutraceutical manufacturers on the global landscape.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407

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