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Infolawyer, Attorney
Category: Business Law
Satisfied Customers: 1780
Experience:  Experienced lawyer
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We have a predicate TENs electrode that also using a static

Customer Question

We have a predicate TENs electrode that also using a static magnetic field and a manufacturer with both CE and FDA approval for their electrode.We plan on using the existing marketed and 510(k) approved TENS electrode of another company as our predicate device.We have a 510(k) application with FDA and the initial response was"FDA today would not approve the predicate device we plan to use if the TENS electrode was submitted today"The static magnet component to our TENS electrode is roughly 2500 militesla and much less the the current 8 tesla field strength approved by the FDA for MRI machines and regarded as safe.We have marketed the magnetic component to our electrode for over the counter use for "everyday aches and pains" for over 15 years and a former business entity has sold hundreds of thousands of the magnetic device with no safety issues.The magnetic component is approved as a class one device in Australia and we are in the process of CE class one approval.We think our 510(k) request for our electrode should be a simple task However,we have met and worked with the FDA before and their opinion and policies are always in flux it seems.
Submitted: 6 years ago.
Category: Business Law
Expert:  Law Educator, Esq. replied 6 years ago.
What is the question, I do not see one in your statement above?
Customer: replied 6 years ago.
Do you have experience with FDA regulatory
Expert:  Law Educator, Esq. replied 6 years ago.
Some, but quite honestly without actually reviewing your application and designs we can only answer general questions and this service is not intended to substitute for you hiring a local FDA attorney to take up your case.
Customer: replied 6 years ago.

I was absolutely misguided when I thought a technical intellectual property

question could have possibly been answered by this service.I appologize from taking your time.Yes,we have hired several "FDA expert" regulatory consultants.

Thank you for your candid response and defering my question.