• Regulatory NewsRegulatory News

    Medical Device Performance Goals: FDA Offers a Quarterly Update

    The US Food and Drug Administration (FDA) on Friday released its latest performance data, revealing that the number of premarket applications (PMAs) for devices with a major deficiency letter on the first FDA review cycle is up to its highest level ever, and up more than 25% since 2015. On the approval side, FDA’s Center for Devices and Radiological Health (CDRH) continues to approve PMAs at a high rate and almost as quickly as the agency ever has. For 510(...
  • Regulatory NewsRegulatory News

    New FDA Draft Guidance on Bringing New, Innovative Devices to Market Using 510(k) Process

    The US Food and Drug Administration (FDA) today issued a new draft guidance on the 510(k) process outlining the factors companies should consider when trying to bring a new device to market. Background The 510(k), or premarket notification, process differs from the premarket approval process in that regulators are partially assessing the safety and efficacy of the device based on its substantial equivalence (SE) to an already-marketed product, known as a predicate devic...
  • Shuren: Predicate Device 'Loophole' Must Be Closed

    The head of the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is calling for the end to a so-called "loophole" in the 510(k) medical device approval pathway . In remarks to Bloomberg News , CDRH Director Jeffery Shuren said that the agency needs new authority to reject new devices that are seeking approval based on being substantially equivalent to predicate devices that were subject to safety recalls. The 510(k) application...