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  • 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

    Experts Question FDA Proposal to Conduct Manufacturing Inspections for De Novo Reviews

    Industry experts raised questions around the US Food and Drug Administration (FDA) recent proposal that would allow FDA to inspect manufacturing facilities prior to granting de novo classification requests. The proposal is part of the 76-page proposed rule FDA’s Center for Devices and Radiological Health (CDRH) set forth last December. The proposed rule addresses the lack of de novo-specific regulation that puts the program at a disadvantage compared to the traditiona...
  • 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 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

    House E&C Questions Insulin Manufacturers

    The House Committee on Energy and Commerce (E&C) on Wednesday sent letters to the three insulin manufacturers serving the US: Eli Lilly, Novo Nordisk and Sanofi, seeking more information on the root causes of the rising cost of insulin. First discovered more than 100 years ago, average insulin prices nearly tripled between 2002 and 2013 and then nearly doubled between 2012 and 2016, with patients bearing the brunt of those price spikes. Now, just a day after two moth...
  • 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

    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 Issues Final Orders on 6 Medical Device Classifications

    A set of final orders issued by the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) on Thursday established new classifications for six device types.   The final orders cover devices indicated for use in surgery, ophthalmology, anesthesiology and neurology, and classify five new device types into class II (special controls) and one into class I. The classifications were developed based on the de novo classification requests CDRH rece...
  • Regulatory NewsRegulatory News

    CDRH Works to Develop Proposed De Novo Regulation

    The regulatory review pathway for novel devices will receive major policy clarifications by mid-2019, program lead at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) said during a forum at RAPS’ 2018 Regulatory Convergence. The de novo program—established about 20 years ago as a mechanism to evaluate devices that are by statute automatically classified into Class III—saw an anomaly in 2017 prior to its first user fees, noted...
  • Regulatory NewsRegulatory News

    De Novo Classifications: FDA Drafts Guidance on Acceptance Reviews, Finalizes Guidance From 2014

    Following the creation of a new De Novo classification request user fee under the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV) of $93,017 (small businesses pay $23,254), the US Food and Drug Administration (FDA) on Friday released one final guidance and one draft guidance. The draft and final guidance come as FDA has seen an increased De Novo submission volume, from 42 submissions in 2014 to 69 in 2017. The draft guidance, when finalized...
  • Regulatory NewsRegulatory News

    FDA Issues 8 Guidances on Device User Fees, MDUFA IV Goals & Pre-Submissions

    The US Food and Drug Administration (FDA) has issued seven new or updated guidances offering advice to medical device makers on its user fee programs and how FDA and industry actions impact the performance goals set by the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV). In its MDUFA IV commitments, FDA agreed to tighter timelines to reach decisions for most medical device submissions in exchange for increased user fees and the introduction of a n...
  • Feature ArticlesFeature Articles

    Spain Reimbursement Profile

    This profile summarizes the reimbursement process in Spain, presents key stakeholders and highlights what should be considered early in the development process. Obtaining regulatory approval for medicines is the first major hurdle of most pharmaceutical and biotechnology companies looking to launch their products worldwide. However, obtaining market access once products are authorized by regulatory agencies (e.g., AEMPS) is a separate and crucial process without which ...