• Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Australia Proposes to Align Device Regulations With EU (1 August 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Seeks Feedback on Proposed Alignment of Australian and European Medical Device Rules The Therapeutic Goods Administration (TGA) of Australia is proposing to align parts of its medical device regulatory requirements with those in place in Europe. TGA is gathering feedback on plans to reclassify surgical mesh and place new requirements on manufacturers of implants wi...
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    Sandoz First Company to File for Biosimilar Approval in US Under New Pathway

    Biopharmaceutical company Sandoz, a Novartis subsidiary, has announced that it has filed the first-ever biosimilar application in the US with the Food and Drug Administration (FDA) using its 351(k) pathway. Sandoz Statement The company's announcement, made 24 July 2014, says FDA has already accepted its filing for a biosimilar Neupogen (filgrastim), an FDA-approved treatment used to decrease rates of infection in patients with nonmyeloid malignancies who are already r...
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    What's the Best Time to Submit a 510(k) Application to FDA?

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional. The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com .  What if there was a particular month when your submission would be cleared f...
  • 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...
  • 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 ...
  • 510(k) Filing Strategy Could Become Used More After Successful Launch of Eye Device

    The 510(k) approval process used by North Carolina company TearScience could represent a new and imitable strategy for other companies to follow, said TearScience CEO Tim Willis in remarks to Med City News on 7 February . The company's device, the LipiFlow Thermal Pulsation System, is used to treat dry eye by clearing channels that supply the eye with moisture-retaining oils. The company applied for 510(k) clearance in two separate filings, and received clearance ...