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Medical Devices

 Medical Device is defined by the FDA as:

  • "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

 Currently medical devices fall into one of three medical device classifications: Class I, Class II, and Class III.  Class I includes devices with the lowest risk and Class III includes those with the greatest risk. 

Compliance, Regulatory Strategy and FDA Submission

  • Provide short and long term regulatory strategy for medical devices, IVDs, and combination products
  • Serve as expert witnesses for litigation matters related to medical device regulation and technologies
  • Perform due diligence assessments
  • Represent clients in interactions with FDA
  • Assist clients in preparing for FDA meetings and FDA Advisory Panel meetings
  • Prepare or assist in the preparation of regulatory submissions for medical devices, including 510(k)s, PMAs, IDEs, de novos, Pre-Submissions, HDEs, 513gs and RFDs
  • Assist clients with development of bench, animal and clinical testing protocols and interpreting results
  • Provide clients with a comprehensive "FDA style" review of submissions
  • Assist with responding to FDA deficiency letters

 Quality Systems and Audits

  • Assist with Quality System documentation development including expert technical reviews of software development procedures
  • Provide in-house training on FDA regulatory issues and new policy developments
  • Perform mock audits