1. 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...
  2. 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...
  3. 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.
  4. 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...
  5. 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...
  6. 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...
  7. 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 https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM626541.pdf
  8. 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.
  9. 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...
  10. 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...
  11. D

    Lifetime of the Medical Device

    As a medical device contract manufacture, my company is often required to determine the lifetime of a device; however, since we don't hold the 510K or do any post-market surveillance, we are typically dependent on the company placing the device on the market for this information. The problem is...
  12. Marcelo Antunes

    Medical Device News FDA - Eliminating Routine FDA news 14-09-18 - Re-Review of Third Party 510(k) Reviews

    FDA - Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews...
  13. Marcelo Antunes

    Medical Device News FDA News - 06-09-18 - FDA - Quality in 510(k) "Quik" Review Program Pilot

    FDA - Quality in 510(k) "Quik" Review Program Pilot 510(k) Program Pilots
  14. J

    Class 1 Medical Device ECR (Engineering Change Request) Changes

    Class 1 device not requiring a 510k still be reviewed by regulatory per 878.9 for engineering change request? I would be using document k97-1 for guidance and documentation. Thanks
  15. R

    How to keep track of all FDA rules and regulations for medical device companies

    Is it just me or is there anyone else having difficulties keeping track FDA rules and regulations for medical device companies. The company I work at is going to apply for FDA 510k and CE mark. We follow all the guidelines, but it is getting harder and harder to keep track of all requirements...
  16. S

    Commercialisation challenge related to FURLS & GUDID

    Hi folks, From the moment of 510(k) clearance there is little time (~30 days) to complete registration, listing, and GUDID update. Has any of you heard of issued with clients (hospitals and such) refusing to to accept a product because the registration is not completed or GUDID is no updated...
  17. D

    FDA Registration - MD, OTC or Dietary Supplement

    Hi everyone, I am exploring the possibility to register an alginate based product intended for GERD (gastroesophageal Reflux Disease) as a medical device in US, but it seems nobody have done the same till now (so there is no predicate :frust:--> PMA). Anybody knows if the reason is that FDA...
  18. T

    Is 510k Anesthesia group particularly picky/difficult to work with during 510k?

    Keep hearing this from consultants. Is it real or more industry hyperbole? Device does not deliver anesthesia but technically falls under that group. Its a Class II, Moderate software, not for continuous use
  19. R

    Utilizing supplier 510(k) as part of medical device

    We are hoping to use a supplier's component as part of our device, but this component (device) requires a 510(k). The supplier currently has a 510(k) on this component. What makes this situation interesting is that the rest of the device that the component is being attached to is Class 1 and...
  20. R

    FDA in 2018 - Obstructing and Over-regulating 510(k)

    Has anyone else found the 510(k) process more difficult now than in the past? I recently submitted a 510(k) for a very low risk device, and got 17 major deficiencies and 1 minor deficiency. Some of them are incredibly picky and several do not have any regulatory or guidance document basis...
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