• 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 ...
  • Feature ArticlesFeature Articles

    Expedited Medical Device Submissions in the US: Special 510(k), Abbreviated 510(k), HDE

    US manufacturers seeking clearance for a new device usually submit a Traditional 510(k) application, also known as a Premarket Notification (PMN) or Premarket Approval (PMA) application, to the Food and Drug Administration (FDA). The submission type depends on the device’s regulatory classification under 21 CFR 862–892. Most Class I devices are exempt from the 510(k) requirement; most Class II and a few Class III devices must have a cleared 510(k); and most Class II...
  • Regulatory NewsRegulatory News

    Does FDA Take Longer to Clear 510(k)s From Non-US Companies?

    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 With respect to FDA 510(k) premarket clearances, the country where the submitter i...