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OFW Law Launches FDA DevicEd Training Initiative

OFW Law is proud to announce the launch of its FDA DevicEd Training Initiative.  The initiative is devoted to providing high quality FDA regulatory training to foreign and domestic medical device companies and the advisors who assist them.  Interactive in-person seminars will be developed and presented by OFW Law attorneys specializing in FDA regulation of medical devices.  These attorneys have a combined total of over 80 years of experience practicing FDA medical device law.

“The scope and complexity of FDA’s regulation of medical devices have only increased in recent years, with the swirl of new or revised statutory provisions and draft and final regulations and guidance documents growing all the time.  The OFW Law FDA DevicEd Training Initiative seeks to help device firms and their advisors navigate the often tricky FDA regulatory landscape in which they must conduct business or provide advice,” says Steve Terman, the head of OFW Law’s Medical Device Practice Group.

Besides communicating the regulatory information that companies and their advisors need, the initiative also is intentionally geared at providing practical insights which can be applied on a daily basis by company employees and firms in the medical device industry.  “While knowing what the law and guidance literally say is important, it doesn’t necessarily help you understand what they truly mean in practice so you can avoid regulatory pitfalls.  This is where the initiative can be of practical assistance,” says Neil O’Flaherty, an OFW Law principal attorney specializing in FDA device regulation.

The initiative will offer seminars for those new to the area of FDA medical device regulation as well as seminars targeting a specific area of FDA device regulation or a new regulatory initiative by FDA’s Center for Devices and Radiological Health.  The initiative also offers the opportunity for device firms and their advisors to work with OFW Law to develop and plan customized seminars to meet their specific needs.  “Not all firms need or want training and education on the same topics.  The OFW Law initiative allows them to design and implement training activities which are tailored to their interests and goals,” according to Evan Phelps, another principal attorney specializing in FDA device matters at OFW Law.

Trained and experienced professionals within and outside FDA are critical to a medical device industry which produces and markets safe and effective products.  OFW Law hopes its FDA DevicEd Training Initiative will be beneficial to industry professionals.

Please contact Neil O’Flaherty for more information about the OFW Law FDA DevicEd Training Initiative.

Please note that OFW Law FDA DevicEd Training Initiative sessions are for general informational purposes only.  They are not intended to and do not constitute legal advice and do not establish an attorney/client relationship.  Please contact an attorney and establish an attorney/client relationship if you need legal advice.

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