fda (food and drug administration)

  1. S

    Medical Device Initial Importer (DII) Requirements - Delivery Address

    I have a question on Device Initial Importer (DII) - could this be the entity responsible for the importing device into the US (Importer of Record) or it has to be the physical address where the goods are being delivered to? The disadvantage with registering the physical address is that the...
  2. Marcelo Antunes

    Informational USFDA – Digital Health Update: The FDA Announces an Opportunity for Test Case Volunteers for the Test Plan for the Software Precertification Program

    Digital Health Update: The FDA Announces an Opportunity for Test Case Volunteers for the Test Plan for the Software Precertification Program Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  3. K

    Supplier Controls for Animal Tissue Suppliers for Medical Devices

    Good morning, Can anyone tell me or point me in the direction of a good resource on supplier controls for animal tissue suppliers for medical device. What registrations do they need to have? Certs? What CoCs should we request and so forth. TIA
  4. Marcelo Antunes

    Informational US FDA issued the first warning letter for UDI violations to help ensure compliance

    The FDA issued the first warning letter for UDI violations to help ensure compliance Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  5. Marcelo Antunes

    Informational US FDA – Ethicon Recalls Circular Staplers for Insufficient Firing and Failure to Completely Form Staples

    Ethicon Recalls Circular Staplers for Insufficient Firing and Failure to Completely Form Staples Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  6. Marcelo Antunes

    Informational US FDA – FDA provides updates on the agency’s continued commitment to evaluating postmarket safety of Essure device

    FDA provides updates on the agency’s continued commitment to evaluating postmarket safety of Essure device Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  7. Marcelo Antunes

    Informational US FDA – Patient-Reported Outcomes (PROs) in Medical Device Decision Making

    Patient-Reported Outcomes (PROs) in Medical Device Decision Making Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  8. Marcelo Antunes

    Informational US FDA Guidance update – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

    Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  9. Marcelo Antunes

    Informational US FDA Laser guidances

    Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56) Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57) Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion...
  10. Marcelo Antunes

    Informational US FDA final guidance – Utilizing Animal Studies to Evaluate Organ Preservation Devices

    Utilizing Animal Studies to Evaluate Organ Preservation Devices Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  11. Marcelo Antunes

    Informational US FDA Medical X-ray Imaging Devices guidances

    Medical X-Ray Imaging Devices Conformance with IEC Standards Policy Clarification for Certain Fluoroscopic Equipment Requirements Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  12. D

    USFDA vs NRTL/IEC 17025 Differences - Compliance testing lab

    Hi, Need clarification on the USFDA requirements for compliance testing lab, guidance documents if any and what is the major difference between USFDA requirement Vs IEC 17025/NRTL. please help.
  13. I

    CAP/CLIA Environment - Part 11 Compliance

    Hello Cove Members, I work as a QA Validation Analyst for a cell and dna biorepository which is CAP and CLIA accredited. We store, process, analyze and distribute human bio-specimen samples and provide genetic data to support investigator studies as well as pharma clients. We also manufacture...
  14. K

    Hospital UDI requirements

    Hello, I know the requirements for medical device manufacturers but what requirements are there for hospitals? Are they required to scan the UDI? If a UDI doesn't scan but the human readable is correct, can you rationalize not relabeling the devices?
  15. M

    How to Select FDA Medical Device Product Code?

    In the past, selecting an appropriate FDA product code for our devices wasn't a problem: either we selected based on predicates, or there was a code that neatly described our product. Now, however, I'm a bit undecided. We have a device for which there are multiple potential product codes that...
  16. L

    Payment for Establishment Registration and Device Listing

    Hello, I have a question about registration and listing. We are going to register as a foreign establishment (we are located in Italy) and the US branch of the company will behave as Initial Importer. As a first step, both Manufacturer and Initial Importer needs to pay the annual fee. My...
  17. N

    Time source for paper-based documentation (research nurses)

    I've been asked to develop an SOP about acceptable sources for time references for our research nurses to use in documenting timed and sequential research activities. Our hospital's network has a centralized atomic clock which displays on networked PCs and phones, but the wall clocks in our...
  18. Marcelo Antunes

    Informational US FDA – Priority List of Patient Preference-Sensitive Areas

    Priority List of Patient Preference-Sensitive Areas Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  19. Marcelo Antunes

    Informational US FDA – Patient Preference Information (PPI) in Medical Device Decision-Making

    Patient Preference Information (PPI) in Medical Device Decision-Making Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  20. Marcelo Antunes

    Informational US FDA – Reorganization of The Center for Devices and Radiological Health

    Reorganization of The Center for Devices and Radiological Health Office of Product Evaluation and Quality Implementing a Team-Based Approach to Medical Device and Radiological Product Evaluation and Quality CDRH Management Directory by Organization Posted at Marcelo's Medicaldevice.expert...
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