RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    510(k) Modernization: FDA Floats Need to Pursue New Authority

    Plans at the US Food and Drug Administration (FDA) to “modernize” the most commonly used pathway for new medical device clearances “might require new authority,” FDA leadership said on Monday. FDA Commissioner Scott Gottlieb and Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), issued a joint statement to announce 2018 progress on novel device approvals, pointing out that the breakthrough 510(k) is one of two submission types that was new...
  • Regulatory NewsRegulatory News

    CDRH Outlines Next Steps to Implement New Safety and Performance Based Pathway

    Following Tuesday’s final guidance that established a new option for 510(k) clearance, a spokesperson from the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) highlighted next steps to implement the new Safety and Performance Based Pathway in 2019. “Our next step is to develop an implementation plan to apply this Safety and Performance Based Pathway,” CDRH spokesperson Angela Stark told Focus . “We encourage industry and o...
  • Regulatory NewsRegulatory News

    CDRH Revamps 510(k) Clearances With ‘Safety and Performance Based Pathway’

    A US Food and Drug Administration (FDA) final guidance sets the stage for how the agency intends to make the voluntary option for 510(k) clearance the main pathway for medical device regulatory reviews. The April 2018 draft version was finalized with a new title that is also the new name of the expanded alternative approach: “Safety and Performance Based Pathway.” The draft guidance proposed to expand the Abbreviated 510(k) program at FDA’s Center for Devices and Radi...
  • Regulatory NewsRegulatory News

    FDA Proposes Rule to Implement New De Novo Classification Process

    The US Food and Drug Administration (FDA) issued a proposed rule on Tuesday to establish requirements on the de novo review pathway for classifying new medical device types. If finalized, the rule will implement the de novo classification process and define the scope of regulatory procedures used by agency staff and classification panels convened by FDA when classifying and reclassifying medical devices. The work at FDA’s Center for Devices and Radiological Health (C...
  • Regulatory NewsRegulatory News

    Special 510(k)s: CDRH’s Proposed Program Expansion Draws Mixed Reactions

    Industry cautioned the special 510(k) program expansion proposal could yield the opposite of its intended goal and further limit eligibility of changes that undergo special 510(k) reviews. The main concern among several device companies, including Thermo Fisher Scientific, Cook Group and Fresenius Kabi USA, relates to a lack of clarity around the process used by agency staff to determine whether a submitted special 510(k) will be converted to a traditional 510(k) prior ...
  • Regulatory NewsRegulatory News

    FDA Reissues Two Draft Guidances on Blood Glucose Monitoring Test Systems

    The US Food and Drug Administration (FDA) on Thursday reissued two draft guidances to help manufacturers conduct performance studies on blood glucose monitoring test systems (BGMS) for point of care (POC) and over-the-counter (OTC) use and prepare 510(k) submissions for both device types. Both draft guidances propose changes to 2016 final guidances “based on feedback from stakeholders requesting more clarification on language,” FDA spokesperson Jennifer Rodriguez said...
  • Regulatory NewsRegulatory News

    CDRH Redrafts Policies on CLIA Waivers for IVDs

    The US Food and Drug Administration (FDA) reissued two draft guidances on Wednesday to help in vitro diagnostic (IVD) manufacturers apply for and obtain Clinical Laboratory Improvement Amendments (CLIA) waivers. The newly drafted guidance documents—first issued last November—were updated to reflect input from the comment period that closed after an extension granted per the request of the Coalition for CLIA Waiver Reform earlier this year. Modifications to the 2017...
  • Regulatory NewsRegulatory News

    Experts Question Impact on Innovation, FDA Authority to Pursue Revamp of 510(k) Pathway

    Following Monday’s announcement from the US Food and Drug Administration (FDA) on its plans to remodel one of the review pathways for medical devices, industry trade associations pushed back on certain parts of the proposal that may hinder innovation. AdvaMed and the Medical Device Manufacturer Association (MDMA), among others, expressed mixed reactions to FDA’s policy proposals for modernization of the decades-old 510(k) framework. The device groups agreed with FDA ...
  • Regulatory NewsRegulatory News

    FDA Seeks to Overhaul 510(k) Program in Push for Modern Performance Standards

    While seeking to safeguard its gold standard for approvals, the US Food and Drug Administration (FDA) is modernizing its 510(k) regulatory review pathway, with more of a focus on predicate medical devices that are 10 years old or less. “We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria,” FDA Commissi...
  • Regulatory NewsRegulatory News

    CDRH Clarifies What Success Means for Special 510(k) Pilot

    Officials at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) clarified on Thursday how the center intends to assess the success of its new special 510(k) program pilot based on the types of information to be collected.   Last month, CDRH issued draft guidance to propose certain modifications to the existing special 510(k) program aimed at expanding device eligibility criteria and subsequently launched a new pilot to ope...
  • Regulatory NewsRegulatory News

    CDRH Finalizes Classifications on Anesthesiology, ENT Medical Devices

    The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) issued two final orders Thursday, classifying an anesthesiology and an ENT device into class II.   The classifications complete the work on the de novo classification requests submitted to CDRH in early 2017. Vapotherm’s de novo request for the classification of the Precision Flow HVNI, which is designed to help patients breathe easily, was granted in April. The de novo request for ...
  • Regulatory NewsRegulatory News

    CDRH Launches New 510(k) Pilot Program for Certain Ophthalmic Devices

    The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) launched a new voluntary 510(k) pilot program to develop and refine individual premarket testing recommendations for ophthalmic optical coherence tomography (OCT) devices.   Under the pilot program, the individual premarket testing recommendations CDRH staff will seek to refine in collaboration with participating manufacturers are aimed at enabling greater consistency in 510(k) s...