The Learning Portal will be under maintenance Friday, 28 January from 10PM to 12AM. Portal functionality may be unavailable intermittently during this window.
We apologize for any inconvenience caused during this time.

  • Regulatory NewsRegulatory News

    FDA’s De Novo Program Gains Momentum

    The US Food and Drug Administration (FDA) has been steadily increasing the annual number of granted de novo classification requests in recent years and hit a record of 44 de novos granted during 2018. The de novo premarket review pathway, used for novel, low-to-moderate-risk devices that are not substantially equivalent to already marketed devices, has increasingly attracted interest in the medical device ecosystem, particularly after the quick turnaround for Apple’s g...
  • Regulatory NewsRegulatory News

    FDA Classifies IVDs for Bacillus Detection

    In vitro diagnostic (IVD) devices for the detection of the Bacillus species were assigned to class II on Friday, following the release of a US Food and Drug Administration (FDA) final rule. The IVDs are prescription devices and indicated to aid in the diagnosis of diseases caused by the Bacillus species, including anthrax. They are intended for the detection and differentiation of the bacteria, such as Bacillus anthracis , and had been unclassified devices prior ...
  • Regulatory NewsRegulatory News

    CDRH Classifies Software App for Contraception into Class II

    Following the 2018 US Food and Drug Administration (FDA) approval of the country’s first mobile medical application indicated for contraceptive use, the agency issued a final order Tuesday to classify the software app for contraception as a class II device. The regulation set forth in the final order comes as a result of the 2017 de novo classification request FDA’s Center for Devices and Radiological Health (CDRH) granted  to Swedish startup company Natural Cycles Nor...
  • Regulatory NewsRegulatory News

    CDRH Seeks to Exempt Certain Flow Cytometers from 510(k) Reviews

    The US Food and Drug Administration (FDA) issued a proposed order Tuesday to exempt certain flow cytometer instruments from 510(k) requirements. The flow cytometer instruments are currently regulated by the agency as class II devices, which are subject to 510(k) reviews. But FDA’s Center for Devices and Radiological Health (CDRH) has determined premarket notification is no longer necessary to provide reasonable assurance of safety and effectiveness prior to market entry...
  • Regulatory NewsRegulatory News

    CDRH Classifies Auto Titration Device for Oral Appliances

    The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) finalized on Tuesday the classification of the auto titration device for oral appliances into class II with special controls. The final order sets the new regulation on the dental device type based on the regulatory review of the 2017 de novo classification request CDRH granted to Zephyr Sleep Technologies’ MATRx plus, classifying the device into class II in August 2018. I...
  • Regulatory NewsRegulatory News

    Drugmakers Debate Whether Parts of FDA’s Biosimilar Guidance are Unconstitutional

    Drugmakers and trade groups have raised questions with two US Food and Drug Administration (FDA) guidance documents on biosimilars, including one explaining how FDA plans to transfer drugs previously approved under new drug applications (NDAs) to be biologic license applications (BLAs). On this so-called “Deemed to be a License” guidance , which explains the NDA to BLA transition, all but one of the biopharma companies and industry groups took issue with the agency’s a...
  • Regulatory NewsRegulatory News

    CDRH Fleshes Out Guidance on Application of Least Burdensome Provisions

    The US Food and Drug Administration (FDA) on Monday published final guidance on the FD&C Act’s least burdensome provisions for the regulation of medical devices, highlighting recent initiatives via newly added themes. The 24-page document, which finalizes a draft from December 2017, is intended to reflect guiding principles that require “the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient...
  • 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 ...