At the May 21, 2014 Medical Device Roundtable, Jennifer L. Beidel, an attorney in the White Collar and Government Enforcement Practice, provided an overview of compliance risks associated with medical device companies.  Below are some of the takeaways from this Roundtable.

  • Your best defense is to have a robust compliance program in place.
    • Make sure your product is safe.
    • Have strong compliance programs, but don’t set a standard you can’t achieve.  It’s better to adopt a less strict standard and enforce it 100% of the time than to set an ideal standard and not meet/enforce it.
    • Have an achievable standard.
    • Get compliance certificates from your suppliers.
  •  If your company is targeted by the government:
    • Know that the government wants to get to your employees before you do.  How you act during the first day of the investigation is important.  Take the time to set up a protocol and inform your people of what is expected from them from the very beginning.
    • Your first call should always be to legal counsel.
  •  If you find that you have an adverse event, make sure to report it, no matter how small.
  • When it comes to your manufacturers and distributors, make sure you select carefully, as the FDA will hold you responsible for their compliance.  
  • Market only in accordance with FDA approved labeling.  Off-label marketing is an absolute no-no.