• Regulatory NewsRegulatory News

    FDA Expanding Device Program Intended to Make 510(k) Submissions Easier

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is once again expanding an electronic submission pilot program meant to make it substantially easier for companies to create and submit a 510(k) premarket submission to the agency. Background As explained by FDA in May 2014, its new 510(k) eSubmissions Program will help guide companies through the construction and submission of a premarket notification [510(k)] application, "el...
  • Regulatory NewsRegulatory News

    107 Types of Medical Devices to be Given Regulatory Exemptions Under New FDA Proposal

    The US Food and Drug Administration (FDA) announced Thursday its intent to exempt dozens of medical devices from its premarket notification (also known as 510(k)) regulations. Background During the 2012 negotiation of the Food and Drug Administration Safety and Innovation Act (FDASIA) , FDA committed to proposing (within two years) low-risk medical devices which could be exempted from premarket notification. ( See FDA's Commitment Letter here ) But what does F...
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    FDA Issues Guidance on 'Substantial Equivalence' Process Used to Bring Devices to Market

    The US Food and Drug Administration (FDA) has issued an extensive and long-awaited guidance document on its premarket notification program—also known as the 510(k) pathway—detailing how regulators will evaluate applications in order to determine "substantial equivalence." 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 subst...
  • 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    New FDA Draft Guidance on Bringing New, Innovative Devices to Market Using 510(k) Process

    The US Food and Drug Administration (FDA) today issued a new draft guidance on the 510(k) process outlining the factors companies should consider when trying to bring a new device to market.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...
  • New 510(k) Pilot Program Aims to Take the Frustration out of Submissions

    Each year in the US, millions of Americans choose to utilize the services of an online tax preparation service like TurboTax, H&R Block, TaxACT and others. The Internal Revenue Service (IRS) has also gotten into the business of making it easier to file with its own Free File Software , available to consumers making less than a certain income. Despite its cost, the software is popular because it makes filing taxes-ordinarily a time-consuming, confusing and otherwise ...
  • In Major Victory for Industry, FDA says Existing 510(k) Guidance to Remain 'Mostly Unchanged'

    The US Food and Drug Administration (FDA) has released the text of a congressionally mandated report outlining its plans for the future of its medical device premarket notification process-also known as the 510(k) clearance process-saying that it intends to largely leave its existing 1997 guidance document as-is. Background In 2011, FDA released a new guidance document,  510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Devic...
  • European Commission Proposes Major Overhaul of EU Device Legislation

    • 27 September 2012
    The European Commission has just released two highly anticipated proposed regulations set to revamp the medical device regulatory framework in the EU-one for  general medical devices , including active implantables, and another for  in vitro devices -imposing tougher rules for assessing the safety and monitoring the use of medical devices and implants. The proposed regulations come after weak EU medical device regulations were partly blamed for a global scandal...
  • European Legislators Propose Premarket Approval System for Some Medical Devices

    Legislators of the European Parliament (EP) have proposed more stringent safety measures for implantable medical devices, including implant registries, tougher safety inspections, better product traceability and-perhaps most importantly-a premarket authorization system. The proposed changes come after the discovery of widespread quality issues with now-defunct French implant manufacturer Poly Implant Prothese's breast implant products. The products are purported to have ...
  • Coalition Protests Aneurysms Treatment Device Approval

    • 02 March 2012
    A patient safety coalition is asking the US Food and Drug Administration (FDA) for more testing into a device that treats complications from aneurysms treatments. According to a report by Qmed, a letter was sent to FDA commissioner Margaret Hamburg urging that the device, the endovascular suturing system, should have been classified as high risk and subjected to more rigorous testing. FDA granted approval after a study involving 10 women and 144 men under the de novo pr...
  • FDA Releases Draft Guidance for Industry on Safety Data Collection

    The US Food and Drug Administration (FDA) released new draft guidance for industry entitled Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations on 9 February. The document provides guidance on how to determine the amounts and types of safety data to collect in trials conducted late in the premarketing process or after a product's approval. The guidance will also allow sponsors of clinical trials to...