Regulatory Pathways

Knowing the device code(s) and classification and registering with the FDA is required by law for all medical devices being sold in the United States.  For international companies looking to enter the US market a US Agent is also required.  Rives can help demystify determining the correct product code and classification as well as how you want to position the product in terms of the indication for use and intended use.

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In addition to the FDA requirements there may also be electrical and safety requirements such as IEC 60601-1 and 60601-2 being two of the most common.  Rives can assist in determining what certifications may be required and connect you to appropriate certified testing  facilities to insure you meet these requirements.

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In addition to these requirements HIPAA compliance is an ongoing issue if you are transmitting any PHI.  Rives generally recommends 3rd party testing for HIPAA compliance and insuring that the data is safe from a cybersecurity standpoint.  Most facilities in the US will require a BAA (business associate agreement) to protect them in the event of a data breach.  3rd party testing will reduce the businesses risk for such events.

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But along with the regulations there is also the strategy of how to approach the FDA.  Much of the time, a pre-sub meeting is utilized to help inform the FDA of the company's plans and build a relationship with the FDA.  This can often times expedite the review process, but most importantly gets valuable information back to the company from the FDA.  Rives participates in these meetings and can be on site with the FDA for such meetings.

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