premarket review process

  1. J

    PMS Competitor Device product data from (MAUDE or TPLC)

    We recently updated our PMS review process and now require competitor product data to gather from (MAUDE or TPLC). We will be summarizing this data by product family. We need atleast one competitor product per family. Can you provide input on how to look for competitor products per family...
  2. Marcelo Antunes

    Medical Device News IMDRF update - 26-09-18 - Cybersecurity, Premarket Reviews, Personalized Devices

    IMDRF Takes Up Cybersecurity, Premarket Reviews, Personalized Device Pathways IMDRF Takes Up Cybersecurity, Premarket Reviews, Personalized Device Pathways | RAPS
  3. Marcelo Antunes

    Medical Device News FDA news -11-09-18 - Review of Cybersecurity into Premarket Review

    U.S. Department of Health & Human Services Office of Inspector General report: FDA Should Further Integrate Its Review of Cybersecurity Into the Premarket Review Process for Medical Devices
  4. Marcelo Antunes

    Medical Device News FDA news - 05-09-18 - Draft - Uncertainty in Benefit-Risk Determinations

    FDA - Draft Guidance on Considering Uncertainty in Making Benefit-Risk Determinations to Support Certain Premarket Decisions for Medical Devices
  5. Ajit Basrur

    CDRH Premarket Approval Application Critical to Quality Pilot Program

    The Food and Drug Administration's (FDA or Agency or we) Center for Devices and Radiological Health (CDRH or Center), Office of Compliance (OC) and Office of In Vitro Diagnostics and Radiological Health (OIR) is announcing its Premarket Approval Application Critical to Quality (PMA CtQ) pilot...
  6. M

    Questions regarding Medical Device Software "Level of Concern"

    In the FDA Guidance for for the Content of Premarket Submissions for Software Contained in Medical Devices, determining the Level of Concern requires a determination of what level of injury could result from failure. I have two questions: 1. Is this determination based on only failure or...
  7. Q

    FDA Consensus Standard for PMA (Pre-Market Approval)

    Hi, I need some guidance from your previous PMA submission where you have used FDA consensus standard. 1) For the PMA - Do we fill the FORM FDA 3654 or Declaration of Conformity for the particular the standard ( Following the Guidance Doc Recognition and use of consensus standards) 2)...
  8. V

    510(K) Cyber Security Documentation for Pre-market Submission (Templates)

    Hi I need to prepare the cyber security documents for pre-market submission. Could anyone provide me templates
  9. S

    FDA CDRH Premarket Review Submission Cover Sheet - adding more products

    Dear Friend this is my first post on this forum. We have Six models of a particular medical device and all are same in functions except outer shape. Now the problem is that form 3514 section F has only FIVE ROWS and i have to add six models in that form.Also there is no option for adding Sixth...
  10. R

    Cybersecurity for Medical Devices and Hospital Networks The draft guidance for premarket submissions can be found here:
  11. R

    FDA CDRH Premarket Review Requirements - Submission Cover Sheet

    Hello Group, REG: CDRH premarket review Submission Cover sheet , SECTION I , Utilization of standards. Link :FDA website " Recognized Consensus Standard" I would like to know if the utilization of standard needs to be the one from FDA database or will it be ok to mention the Standards in...
  12. S

    USFDA User Fee Rates for 2012

    Hi All, The U.S. FDA is going to drop user fees for medical device companies by about 7 percent in 2012. For 510(k) premarket submissions, companies will have to pay $4,049 per submission, when compared to the $4,348 payment in 2011. Please refer below site for complete details...
  13. Michael Malis

    FDA issued modifications to the list of standards used in Premarket Review Process

    FDA has issued modifications to the list of standards used by the agency in its premarket review process for medical devices. This move is intended to help device manufacturers that declare conformity with nationally and internationally developed consensus standards comply with requirements...
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