FDA Regulatory Updates in Medical Device


Date: TBA
Location: Psagot, Hamada 8, Rehovot
General Information
Duration: 1 - Day Course
Hours: 08:30 – 17:00
Price: 1,850 NIS + VAT
Credit Points: 1
SKU: 19643
Course Language: Hebrew
About the Course
Regulatory requirements are evolving on a daily basis. This training is meant to help professionals catch up with some of the important changes in the field that may influence their work life.

The FDA has been experiencing intense (and often conflicting) pressures from Congress, the industry, and the media to improve and accelerate its review process while at the same time to tighten its supervision of previously cleared devices.

The FDA has responded by initiating in January 2011 a Plan of Action to modernize and improve the premarket review of medical devices, and to enhance the level of transparency and predictability of its actions. As part of this Action Plan, the FDA has greatly accelerated its rate of publishing new guidance documents – during 2012 and late 2011, over 10 guidance documents were updated and over 10 draft guidance documents published.

In the present course we will discuss some of the most important of these new publications, focusing on issues related to regulatory submissions and to post-marketing surveillance.
Who should attend
  • Regulatory affairs professionals
  • QA Managers
  • Investors and Management of companies that are already in the market
  • Investors and Management of companies that intend to market their products in the US
FDA Regulatory Updates in Medical Device
Benefits to the Participants
At the end of this course you will learn:
  • Updates – What was updated lately and what is the FDA current way of thinking?
  • the De Novo submission pathway – How to make use of the De Novo submission pathway for your own benefit?
  • A Pre-Sub meeting with the FDA – How can a Pre-Sub meeting with the FDA be used to put your design effort onto the right track?
  • Submition of an eCopy – How to submit an eCopy that will answer all FDA requirements?
  • Regulatory submissions – What are the updated  'do's and 'don'ts' with regard to regulatory submissions to the FDA
  • Home-use a device – What unique design considerations to take when designing a device intended for home-use
  • Requests for information – How to submit 513(g) requests for information
  • Post-marketing surveillance – What are the updated FDA requirements with regard to post-marketing surveillance
Contact us
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  • Notes
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Issues to be covered
  • 510k process updates:
    • Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics, Draft Guidance, 15 July 2014.
  • FDA requirements regarding the data that is to be presented in premarket submissions:
    • Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States, Draft Guidance, 22 April 2015.
  • Relaxation of Control of low risk devices:
    • General Wellness: Policy for Low Risk Devices, Draft Guidance, 20 Jan 2015.
    • Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements, Guidance, 1 July 2015.
    • Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices, Guidance, 9 February 2015.
    • Mobile Medical Applications, Guidance, 9 February 2015 (draft version was discussed in the December 2013 Bioforum course).
  • Use of Social Media – Does and Don'ts:
    • Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices, Draft Guidance, June 2014.
    • Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices, Draft Guidance, June 2014.
  • Reprocessing:
  • Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Guidance, 17 March 2015.
About The Lecturer

Ms. Sarit Gelbert


For more information please click here


Mr. Shlomi Harpaz

Mr. Shlomi Harpaz holds a M.Sc. and B.Sc. in biomedical engineering from the Technion, as well as an M.A. in general history. In his work as a regulatory and quality consultant at H.M.Da, Shlomi has been providing medical device companies with consultation throughout the product development process, and has helped companies define their regulatory routes and submit their product to the FDA and to Notified Bodies.
For more information please click here


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