• Regulatory NewsRegulatory News

    FDA Device Approvals Speedy in First Half of 2014, With Even Faster Approvals Coming Soon

    The US Food and Drug Administration (FDA) approved new medical device products at a pace nearly twice that of the year prior, according to a new report just published by analysts at EP Vantage, the market intelligence branch of Evaluate. New Report EP Vantage's half-year report looked at all medical devices approved by FDA through its Premarket Approval (PMA) pathway and its Humanitarian Device Exemption (HDE) pathway —both used almost exclusively by entirely new devic...
  • FDA Cracks Down on Transvaginal Mesh, Will Require Companies to Submit Data or Pull Products

    The US Food and Drug Administration (FDA) has announced that it will seek to regulate transvaginal mesh products more stringently, calling them high-risk devices that will be required to undergo FDA's thorough premarket approval (PMA) process. Background Transvaginal mesh has been used to treat female urological conditions, and in particular those caused by weakened pelvic muscles, which can lead to a pelvic organ prolapse (POP). In the EU, they have been used since the...
  • FDA Launches Long-Awaited Expedited Approval Program Aimed at High-Need Devices

    The US Food and Drug Administration (FDA) has released a long-awaited draft guidance document outlining an expedited approval pathway that can be used by sponsors of medical devices intended to treat life-threatening or "irreversibly debilitating" diseases or conditions. Background: EAP Basics The guidance, which for months has been rumored to be near completion , introduces the "Expedited Access Premarket Approval" program, or EAP for short. Regulatory officials said ...
  • CDRH, CBER Finalize Medical Device Review Communication Guidance

    A new guidance document released by the US Food and Drug Administration (FDA) is intended to clarify the types of communication used by FDA and industry during the review of medical device submissions. Those submissions include premarket applications (PMAs), PMA supplements, biologic license applications (BLAs), BLA supplements and premarket notifications [510(k)s]. Background The guidance is intended to reflect changes undertaken by the agency under two pieces of legi...
  • FDA Unveils Strengthened Medical Device Reporting Database With New Features

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has unveiled new improvements to its medical device recalls database, allowing members of industry and the public to more easily associate devices and safety recall issues. Prior to the new database, searches for a device yielded separate results for its labeling/approval information and any recalls. This could be problematic for healthcare providers, who would have no way of kn...
  • FDA Finalizes Extensive Guidance on Pivotal Trials for Medical Devices

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has released an extensive new final guidance document on the design of pivotal clinical investigations meant to support the approval of medical devices. The 57-page guidance, Design Considerations for Pivotal Clinical Investigations for Medical Devices , was first released in draft form August 2011 and pertains to the stages of development in which a device is evaluated for s...
  • CDRH Says Dozens of Applications Affected During Shutdown, and Residual Delays Likely

    The US' political system has seen better days, as evidenced by the recent shutdown of many government services after legislators failed to pass a budget by 1 October 2013. For the US Food and Drug Administration (FDA), which is funded through a mix of appropriated funding and industry-paid user fees, this also meant a lapse in its statutory authority to collect or spend new user fees. And as a recent email sent to the medical device industry indicates, that will result i...
  • Feature ArticlesFeature Articles

    Ambiguity from FDA Stunts Growth in the US, While Innovation Flourishes in Europe

    Editor's note: RAPS is a neutral, non-lobbying organization. The views expressed in this Perspectives piece by Chris Velis, CEO and chairman of MedCap Advisors, are those of the author. We hope this article will stimulate conversation, and we invite you to discuss it in the Regulatory Open Forum on Regulatory Exchange , our private social media community for RAPS members. Current State of Affairs Inconsistency and ambiguity in the US Food and Drug Administration's (F...
  • FDA Finalizes Guidance on Priority Review Process for Medical Devices

    Capping off a week of several long-awaited guidance documents, the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has released yet another guidance document, this one regarding the priority review of premarket application (PMA) and premarket notification (510(k)) submissions to the agency. Background FDA has several programs it uses to accelerate the approval process for medical products. On the pharmaceutical side, it has fast...
  • FDA Data Show the Worst is Over for 510(k), PMA Submissions

    The medical device industry has long complained that the process of obtaining regulatory approval for its devices has become increasingly difficult over the course of the last decade. But in a presentation given to industry at a recent device conference, the US Food and Drug Administration's chief medical device regulator Jeffery Shuren had a message for manufacturers: The worst is over. 510(k): The Worst is Over Shuren, the director of FDA's Center for Devices and Radi...
  • Prominent Consumer Group Petitions FDA for Changes to Device Approval System

    A prominent consumer advocacy group is once again calling for the US Food and Drug Administration (FDA) to make changes to the way it regulates medical devices, saying that the high-profile failure of one implantable medical device is evidence that all others should be classified as high-risk products and held to more stringent testing standards. Background Metal-on-metal hip implants were cleared in recent years through FDA's 510(k) pathway, which allows for companies ...
  • New FDA Guidance Clarifies Process for Submission of Device User Fees

    A new guidance document published by the US Food and Drug Administration (FDA) establishes and otherwise clarifies the process by which biopharmaceutical and medical device companies need to pay user fees to the agency in return for the processing of their premarket approval (PMA) applications and device biologics license applications (BLAs). Background In July 2012, President Barack Obama signed into law the FDA Safety and Innovation Act (FDASIA) , which, among other ...