• US Regulators Approve Fourth Breast Implant Product, Call for Extensive Safety Testing

    If there's one device that global medical device regulators have spent much of the last year worrying about, it's breast implants. But now, and with a nod to safety critics, US regulators have approved a fourth breast implant product for marketing in the US. Background Late in 2011, French regulators began to receive reports that breast implants manufactured by Poly Implant Prothese (PIP) were failing at an alarmingly high rate. The ensuing fallout was in many ways th...
  • FDA Looks to Finally Implement Pediatric Data Requirements for Most Device Submissions

    A new supplemental proposed regulation and related draft guidance document released by the US Food and Drug Administration (FDA) both aim to clarify what is expected of sponsors submitting medical device applications, which are now required to provide information regarding the pediatric subpopulations that suffer from the disease or condition their product is intended to treat. Background In 2007, Congress passed the FDA Amendments Act , a massive piece of legislation ...
  • Electronic CTD Document Updates to Now Allow Information about Medical Devices, FDA Says

    US Food and Drug Administration (FDA) officials have announced the availability of newly revised final documents that describe the recommended process for regulatory professionals to use when submitting electronic versions of the Common Technical Document (eCTD), including a curious update regarding the submission of information on medical device submissions. Background The eCTD is a standard developed and implemented by the International Conference on Harmonisation (...
  • PMA Application to be Required for Controversial Hip Devices, Says FDA

    The US Food and Drug Administration (FDA) has proposed a new rule that would classify all hip joint metal-on-metal semi-constrained prosthesis with either cemented or un-cemented acetabular components as class III medical devices requiring the submission of a premarket approval application (PMA) or a product development protocol (PDP) instead of a 510(k) premarket notification. The devices have been plagued with controversy around the globe. The devices, which claimed ...
  • FDA Finalizes Three Critical Medical Device Guidance Documents

    The US Food and Drug Administration (FDA) has released three final guidance documents regarding the submission of nearly all medical device applications made to the agency. The guidance documents, released on 31 December 2012, pertain to three important aspects of the device submission process: submission, filing and acceptance of applications. In the first guidance, eCopy Program for Medical Device Submissions , FDA has set out to require companies to submit in du...
  • Filing Review Process to See Changes Under Proposed CDRH Guidance

    • 30 July 2012
    The US Food and Drug Administration (FDA) on 30 July released new draft guidance aimed at reducing the variability and subjectivity of when premarket applications (PMAs) submitted to the Center for Devices and Radiological Health (CDRH) are deemed to be "administratively complete." The draft guidance, Acceptance and Filing Review for Premarket Approval Applications , is particularly aimed at "assuring the consistency of our acceptance and filing decisions," FDA expl...
  • Upcoming Medical Device User Fees Unveiled

    • 30 July 2012
    The schedule of fees medical device manufacturers and sponsors will be required to pay under the Medical Device User Fee Act (MDUFA) -part of the recently passed Food and Drug Administration Safety and Innovation Act (FDASIA) -was released on 30 July by US regulators. The fees apply only to the fiscal year between 1 October 2012 and 30 September 2013, after which time an inflation-adjusted set of fees are set to come into effect. The base fee for a premarket applicati...
  • Changes Coming to Medical Device Pre-submission Meeting Program

    The US Food and Drug Administration (FDA) has released new draft guidance for medical device manufacturers looking to meet with the agency in advance of submitting a wide range of device applications. Once finalized, the guidance-which formerly only covered Investigational Device Exemption (IDE) applications-will include 510(k) premarket notification applications, premarket approval (PMA) applications and Humanitarian Device Exemption (HDE) applications. FDA explaine...
  • FDA: Bausch & Lomb Marketed Product Using Rejected Claims for Years

    A warning letter sent to Rochester, NY-based medical device manufacturer Bausch & Lomb, Inc by the US Food and Drug Administration (FDA) accuses the company of marketing its PureVision 2 contact lenses using an explicitly unapproved indication. In its 11 June 2012 letter, FDA explains Bausch submitted a supplement for the device-a tinted contact lens with an approved indication for extended wear -to the agency in 2010 seeking approval for a revised labeling stat...
  • US Regulators Move to Reclassify Medical Device as Class III

    The US Food and Drug Administration (FDA) announced Friday, 6 July that it wants to require sponsors of shortwave diathermy (SWD) devices to file either a premarket approval application (PMA) or complete a product development protocol (PDP) for all but one of the device's indications. SWDs are used to generate deep heat in body tissues using electromagnetic energy. Though they are primarily used to raise the heat of the body tissue, some medical device manufacturers have...
  • US Regulators Reclassify Pacemaker Electrodes as Higher-Risk Devices

    • 06 July 2012
    After a series of problems in which permanent pacemaker electrodes have been associated with adverse events, the US Food and Drug Administration (FDA) said it will reclassify the electrodes as Class III medical devices. As a result of the reclassification, manufacturers of permanent pacemaker electrodes will now be required to submit either a premarket approval application (PMA) or complete a product development protocol (PDP) in order to legally market a permanent pacema...
  • Final FDA Rule Sets Application Requirements for Manufacturers of Pacemakers

    Manufacturers of implantable pacemaker pulse generators and the devices that program them are receiving a final rule from the US Food and Drug Administration (FDA) today informing them of new application filing requirements coming into effect in September 2012. In two separate 22 June Federal Register postings, FDA said manufacturers of pacemaker devices and pacemaker programmers will now be required to file a premarket approval application (PMA) or a complete product ...