Can YOU help? --> Unanswered questions <-- (Other than Marcelo's Informational posts)


  1. B

    Submit a 510(k) with a Predicate cleared but not Listed

    We have received the 510(k) clearance letter. We also have prepared the submission of the new version of the cleared device, a new 510(k) which uses our cleared device as substantially equivalent. The new device includes wireless communication and some other changes but similar intended use...
  2. R

    510(k) Biocompatibility vs Cleaning Validation

    We submitted our 510k for our nasopharyngoscope and our original submission had biocompatibility testing done by our manufacturing partner's testing facility. They performed irritation and cytotoxicity testing. When they performed these tests, they cleaned the device first with a solution of 70%...
  3. G

    How is the labeling of units cleared for both Rx and OTC uses handled?

    Hello, For a unit which 510(k) has both the "Prescription Use" and the "Over-The-Counter Use" checked on its 510(k) summary - how is the labeling supposed to be handled? - one set of artwork for the OTC unit ... a version without Rx functions enabled or claimed? - a separate set of artwork for...
  4. L

    Class IIa Medical Device, CE Mark & 510k - Labeling Content

    We have a class IIa medical device with CE registration and 510k filing underway. For the 510k filing the IFU and labelling had to changed with among those changes a Rx only symbol. This triggered a discussion as the inteded use of the device contains: "shall be used in a clinical environment...
  5. S

    Creating a new commercial product based on a modification to an existing product

    Hi Fellows, An odd situation in the era of compatibility with other devices: Say you have a device with a USB-A port that is able to communicate with external devices to complete its work. Say that through a small modification you are able to installed a USB-C port and connect it to USB-C...
  6. K

    Change of Existing Medical Devices and 510(k)

    Hi We are manufacturer of Medical X-Ray equipment and already approved by FDA for our one of product. We want to know about the changes for which 510(K) re-submission is required. for example , If we are adding any alternate model of X-Ray tube and Flat panel detector (Image capturing device)...
  7. 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
  8. M

    Has anyone here assessed the latest Abbreviated 510(K) guidance document?

    A relatively new FDA abbreviated 510(K) guidance is published and I was wondering if anyone has assessed the gap analysis or created a summary report to state if the updated guidance is applicable to their QMS. Can you please share some ideas or scrubbed version? Thanks!
  9. Ed Panek

    Other company wants to use our FDA 510K bundled with their product

    We are a class II medical device thermometer that broadcasts Bluetooth to our iPhone or Android phone application. Another company wants to bundle our device with their non-medical non-FDA product using their phone app to show the data. I said we should perform a risk analysis for this along...
  10. Marcelo Antunes

    Informational USFDA – Refuse to Accept Policy for 510(k)s

    Guidance Refuse to Accept Policy for 510(k)s Continue reading at Marcelo's website... You may also comment and discuss in this discussion thread.
  11. S

    Legal Manufacturer FDA Reporting Obligations for Using New Contract Sterilization Site

    Company A manufacures Class 2 and Class 3 implantable devices. It adds a brand new contract sterilization sites for its 510k cleared and PMA approved products. For PMA, FDA requires filing FDA 180 day supplement. What regulatory action for the Class 2 product FDA is required? FDA guidance...
  12. T

    Executive summary for Traditional 510(k)

    Hi, I hope somebody could help me solve my dilemma. We are currently preparing 510(k) Traditional submission and I have a checklist and content of the submission. In some documents, and on some blogs, I've seen executive summary being mentioned. The thing that puzzles me the most is that it is...
  13. S

    Are Defibrillator Protection and Pacemaker pulse detection features mandatory as per IEC 60601-2-25 or 2-27...?

    Dear All, If we are planning to apply for FDA 510(k). Is it mandatory to have a Defibrillator protection and Pacemaker pulse detection. Both these tests are part of IEC 60601-2-25 and -2-27 Request you to provide your inputs.
  14. S

    The key differences in 510k types - Traditional vs. Abbreviated vs. Special

    Hi friends, I would like to know the key difference in 510k type ( traditional vs abbreviated vs special). My understanding says ; Traditional - for new device (having a predicated device) and timeline is 90 days. Special : For a device which is already and approved (OEM) and if made any...
  15. K

    Substantial Equivalence Predicate Device Testing

    For Traditional 510k, does the FDA expect companies to test characteristics of both their Subject Device and the competitors Predicate Device to prove Substantial Equivalence (SE). For example, Predicate Device's 510K states the product has a Tamper Design that causes it to destruct to prevent...
  16. Marcelo Antunes

    FDA News US FDA – November 2018 510(k) Clearances

    List of November 2018 510(k) clearances. With the recent suggestions by FDA management on future changes of the 510(k) process, keeping up-to-date with clearances (and potentially predicate devices) is even more important than ever. Lista de Novembro 2018 de 510 (k) clearances. Com as recentes...
  17. Marcelo Antunes

    FDA News FDA Report - FDA Has Taken Steps to Strengthen The 510(k) Program

    FDA Report - FDA Has Taken Steps to Strengthen The 510(k) Program
  18. L

    510 (K) Pre-Sub meeting - Does it worth?

    We are about to submit our 510K, and we are considering to request a Pre submission meeting, but I heard it is a waste of time. If you have any experience on this issue, kindly share it with me.
  19. L

    Traditional 510(K) - Software - Clinical testing?

    Hello Everyone, I am very new in FDA processes. I would like to submit a traditional 510k to our software (almost the same as syngo VD11). We already have a CE mark, so we have a ton of documents, sometimes I don't understand the differences between the two system. Electromagnetic...
  20. J

    Virtual Manufacturer and CE Marking

    Hi, Does an OEM need a CE mark on their product in order for a virtual manufacturer to gain one? For clarity - the OEM has a FDA 510k on it, but the OEM has no intentions of selling in Europe themselves. However, the virtual manufacturer wishes to do so. Is it necessary for the OEM to gain a...
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