• Regulatory NewsRegulatory News

    Are You a Good Witch, or a Bad Witch?

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional.  The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com Upon meeting Dorothy in The Wizard of Oz, Good Witch Glinda asks “Are you a ...
  • New 510(k) Guidance Consolidates Pre-Review Policies

    A new draft guidance document published by the US Food and Drug Administration (FDA) establishes the criteria under which the agency can refuse to accept a 510(k) substantial equivalence application submitted to the agency. 510(k) applications are used to approve devices which are based upon and otherwise substantially equivalent to medical devices approved by FDA. Under the 510(k) process, devices are cleared-not approved-by the agency if they can show substantial equiv...