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fda (food and drug administration)

  1. S

    Where did FDA 510(K) form 3654 go?

    I am doing a new 510(k) and wanted to make sure I'm using the latest version of form 3654 but it seems to be gone. Anyone know anything about it? It isn't in the forms list anymore. FDA Forms
  2. Ajit Basrur

    Requirements for Refurbishment of Medical Devices in Mexico

    My client who is a Specification Developer based in US would like to refurbish medical devices at a supplier in Mexico. With this said, there is no requirement to be FDA Establishment Registration and Device Listing but would like to know what controls should be in place with regards to COFEPRIS...
  3. Marcelo Antunes

    Informational USFDA – Review framework for artificial intelligence-based medical devices

    Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices Artificial Intelligence and Machine Learning in Software as a Medical Device Proposed Regulatory Framework for Modifications to Artificial...
  4. B

    Manufacturing Company Address Change - implications for FDA

    Hello , We are a small business with 510(k) approved devices. We are planning to move our company to a bigger location and change companies legal address. Can someone help as to how should we go about updating our address in FDA and on our approved devices. There is no change other than the...
  5. Marcelo Antunes

    Informational USFDA Draft Guidance – Review and Update of Device Establishment Inspection Processes and Standards

    USFDA Draft Guidance – Review and Update of Device Establishment Inspection Processes and Standards Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  6. Marcelo Antunes

    Informational USFDA Ethylene Oxide Sterilization for Medical Devices website

    USFDA Ethylene Oxide Sterilization for Medical Devices website Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  7. Marcelo Antunes

    Informational FDA Preps for Device Shortages as Another Sterilization Facility Will Close

    FDA Preps for Device Shortages as Another Sterilization Facility Will Close Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  8. Marcelo Antunes

    Informational FDA Panel Recommends New Postmarket Requirements for Breast Implants

    FDA Panel Recommends New Postmarket Requirements for Breast Implants Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  9. Marcelo Antunes

    Informational FDA Posts Information about Ethylene Oxide Sterilization and Medical Devices

    FDA Posts Information about Ethylene Oxide Sterilization and Medical Devices Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  10. Marcelo Antunes

    Informational USFDA – Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Stand

    Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-Ray, Laser and Ultrasonic Products Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this...
  11. Marcelo Antunes

    Informational FDA Panel: Too early to pull textured breast implants over cancer risk, need more data

    FDA Panel: Too early to pull textured breast implants over cancer risk, need more data Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  12. M

    FDA Guidance - general wellness products - wearables

    Has anyone got experience with categorising products as a general wellness product rather than medical device. I have a few questions: 1. Does the manufacturer self-declare that their product is part of the general wellness category? 2. Can manufacturers use the general wellness exemption for a...
  13. Marcelo Antunes

    Informational FDA Qualifies First Biomarker Test as Part of Medical Device Development Tools (MDDT) Program

    The U.S. Food and Drug Administration (FDA) has qualified the OsiriX CDE Software Module through the Medical Device Development Tools (MDDT) program Continue reading at Marcelo's Medicaldevice.expert website... You may also comment and discuss in this discussion thread.
  14. Marcelo Antunes

    Informational USFDA Final Guidance – Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)

    Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Continue reading at Marcelo's Medicaldevice.expert website... You may also comment and discuss in this discussion thread.
  15. Marcelo Antunes

    Informational USFDA – Efforts to evaluate materials in medical devices to address potential safety questions

    Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions Continue reading at Marcelo's Medicaldevice.expert website... You...
  16. Marcelo Antunes

    Informational USFDA – FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051

    FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051 Continue reading at Marcelo's Medicaldevice.expert website... You may also comment and discuss in this discussion thread.
  17. Marcelo Antunes

    Informational USFDA draft guidance – A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry

    A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry Continue reading at Marcelo's Medicaldevice.expert website... You may also comment and discuss in this discussion thread.
  18. C

    FDA Medical Device Label Requirements - serial numbers

    Hello all, I've spent the greater part of my entire day and evening trying to find a clear answer to provide to my manager on Monday about the requirements for including serial numbers, manufacturing date, expiry date, lot/batch number, etc. on medical device labeling. We already know the...
  19. Ed Panek

    Website to ask FDA for guidance in Medical Device Industry?

    Does the FDA host a website where a user can submit questions regarding regulations for medical devices?
  20. N

    Discovery of "hidden" FDA database of malfunctions

    Does anyone know what this is referring to? I have come across it a couple of times now, and I seriously feel so out of touch! A “Hidden” Registry of Device Malfunctions & Injuries FOI Services' collection of FDA documents acquired under the Freedom of Information Act includes over 85,000 files...
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