510(k)

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...

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...

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.

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...

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...

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...

FDA Report - FDA Has Taken Steps to Strengthen The 510(k) Program https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM626541.pdf

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.

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...

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...

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...

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

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

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

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...

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...

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...

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

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...

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...