We are looking for partners in us who take care of fda c-1,2,3 and 510k and clinical trial. We have many customers who need the services. If of interest please contact me via zintro.+14 Other Responses
We are a small medical device company. I have a fda cleared device and i want to add an indication for which no predicate exists. Fda recommended de novo 510(k). I have engaged hogan lovells to manage this submission but i need someone to be our arms, legs, and mind to prepare for pre-sub fda meeting and assist in submission creation. I need a hands-on doer to do real work, not just someone to tell me what to do. This is an exciting new product that is making a difference in lives. It is ce marked and approved in many countries. We are based in gaithersburg maryland just north of washington, dc.+undefined Other Responses
Hi! we need a pre-submission to define the regulatory strategy for an innovative yet simple electrical non invasive medical device serving an under served population of patients. I understand that you might need more details, but i just want to check if the pricing is within our budget. Please let me know what will be your ballpark quote (or price range) and timeline for the following. If your price range is within our budget, i will contact you to move forward with the project.
1. Advising on what things will be needed for preparing a pre-submission.
2. Preparing all sections of the pre-submission.
3. Corresponding with the fda and answering all questions on the pre-submission.
4. Scheduling a meeting with the fda and discussing questions that need to be clarified to clearly define the regulatory strategy (eap/denovo/pma, etc).
5. Creating a final report for lir on regulatory path and testing needed, moving forward, based on the discussion with the fda.
Also if we need a 510k. What are the typical timeline and rates for a 510k? Thanks a lot! sumi+15 Other Responses
Fda 510(k) Guidance
I would like to get a better understandign of the fda 510(k) process. What is all required in the context of my device.
My device is a camera that captures 3d data to allow for highly accurate 3d surface measurements. It will enable better tracking of the healing progress for multiple applications one in particular is chronic wounds.
Thank you.+3 Other Responses