Mission:

legaldevice.com is an integral part of the Law Offices of Donald J. Fournier & Associates. Its mission is to assist organizations involved in the manufacturer or development of medical technologies with quality legal services, including regulatory filings and clinical agreements that foster collaborative research partnerships and facilitate market clearance.

Clinical trial support:

As medical device technologies become more complex, regulatory submissions increasingly require clinical data to demonstrate safety and effectiveness. Whether your organization’s pathway to market is a PMA, 510(k), CE mark, or other, we can assist you with all your legal agreement needs:

 -         Contract Research agreements       

-          Principle Investigator agreements

-          Financial Disclosures

-          Investigational site recruitment

-          Facilitation of IRB approval and renewals

-          Assist with risk assessments and determinations of     significant risk

           Conformity to 21 CFR Parts 812, 56, 54 and 50

-      Ensure compliance with AdvaMed, Foreign Corrupt Practices Act (FCPA), Physician Payment Sunshine Law and all other applicable laws and regulations.

       Regulatory Support:

       - PMA submissions

       - 510(k) submissions

       - CE Mark design dossiers

       - FDA or Competent Authority conferences

The lives medical devices touch depend on performance.

Increasingly, clinical data is required to answer questions of performance that cannot be determined by preclinical studies alone, such as patient outcomes and adverse events.

FD&C Act:

-         Pursuant to the Federal Food, Drug and Cosmetic Act (FD&C Act), device manufacturers must demonstrate their device is safe and effective for the intended use. This typically includes:

- Safety: Device is free from avoidable or unacceptable risk

- Effectiveness: The ability of the device to obtain the desired result (marketing claims) on the intended population, including:

 i) Performance (minimum levels of clinical performance as established by performance standards and/or design requirements), and;

 ii) Clinical Utility: Device is beneficial in the monitoring, diagnosis or treatment of disease, and the benefits of use outweigh the risks.

In short, a manufacturer must demonstrate that the underlying technology of their device does what the manufacturer claims it will do and that its claims are purposeful.

Our attorney resources can assist you in answering these and related questions concerning market clearance. Please CONTACT US for more information.