Blog describes the new FDA eCopy website to help you successfully deliver your first FDA eCopy and to troubleshoot problems with eCopy submissions.
Easlier today I posted a new blog on the topic of “Pre-submission Meeting Request Feedback Methods” on the FDA eCopy website. If you are almost done with preparation of your 510k submission or a pre-submission meeting request, you can save yourself some time and prevent mistakes by visiting my new FDA eCopy website. In October the website and service was launched, and the first customers hired us to help them with printing and shipping their FDA eCopy submissions. In January the first blog was posted, and I will continue posting weekly blogs about 510k submissions and the FDA eCopy process to help you streamline your own printing and shipping of FDA eCopy submissions.
What’s on the FDA eCopy Website?
The FDA eCopy website includes a weekly blog on topics related to FDA 510k submissions, pre-submission meeting requests and other types of FDA submissions that require an FDA eCopy. In addition to the home page which is the weekly blog, you will also find links to the following useful resource pages:
- Share eCopy Now – a page that explains how to submit content to FDA eCopy for your submission using Dropbox or some other file sharing service
- eCopy Service – a page explaining the FDA eCopy service
- Formatting Checklist – a page that explains our FDA eCopy checklist created for internal use to ensure that 100% of FDA eCopy submissions are successfully uploaded by the FDA; the page also has a form for downloading our checklist if you want to create your own FDA eCopy
- Price of Service – a page describing pricing of this printing and shipping service
- Arrival Time – a page that explains when your FDA eCopy will arrive at the FDA in Silver Spring, MD
- FedEx Tracking – if you click on the image of the FedEx airplane on the FDA eCopy website, it will immediately take you to FedEx tracking and you can enter your own tracking number to track your FDA eCopy shipment (don’t worry, it will arrive at 10am and you will receive an acknowledgement just after 4pm the same day)
From now on, most of my blog posts related to 510k submissions will be found the FDA eCopy website. There is one blog specific to eCopy submissions on this website that you might be interested in. Click here if you want to learn how to eliminate hidden system folders from your FDA eCopy flash drive.
If you want to learn more about 510k submissions in general, consider attending one of the live 510k workshops.