Enforcement

KKB handles a wide range of medical device-related enforcement activities by FDA and other federal and state regulatory agencies. These include

  • FDA enforcement proceedings, including the conduct of inspections, responses to inspectional observations, Warning Letters, section 305 hearings, negotiation of consent decrees and litigation
  • FDA-related import and export issues
  • Assistance with recalls

Kleinfeld, Kaplan and Becker, LLP

1140 Nineteenth St. N.W. Suite 900 / Washington, DC 20036 / P 202 223 5120 / F 202 223 5619

Sign up for updates