In this FDA eCopy webinar you will learn the tips for preparing, printing and shipping your own eCopy submission of a 510k, pre-submission request, De Novo application, etc.
When is this FDA eCopy webinar?
The original FDA eCopy webinar was recorded on November 10, 2016 shortly after the FDA eCopy service was launched. We presented an updated webinar about eCopies on Wednesday, August 30, 2017. It’s free to register for the FDA eCopy webinar as long as you ask a question. As new questions are submitted we will add the questions to our 510k FAQs page.
Contents of FDA eCopy webinar
On August 22, 2016 we published a blog posting that is a great example of the kind of information you will learn in the FDA eCopy webinar. Registrants will receive a link to download a recording of the webinar and the native slide deck. You will also receive a copy of my FDA eCopy print and ship template. Additional questions can be asked at any time by sending me an email or scheduling a call on my contact us page.
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 hiring us to prepare, validate, print and ship your FDA eCopy. In October 2016 the website and service was launched, and the first customers hired us to help them with printing and shipping their FDA 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:
- eCopy Service – a page explaining the eCopy service
- Formatting Checklist – a page that explains our 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
- Arrival Time – a page that explains when your submission 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 FedEx shipment (don’t worry, it will arrive at 10am and you will receive an acknowledgement just after 4pm the same day)
Updated 2018 Pricing of FDA eCopy services
At the beginning of 2018, the FDA announced an unofficial change to the eCopy submission policy. The FDA no longer requires the complete paper submission. Instead, you can submit an eCopy accompanied by a paper copy of the signed cover letter. Before February 2018, we would print 1,000+ pages for each 510k submission, pack two 3” three-ring binders in 12”x12”x6” ULine boxes and ship the box to the FDA overnight via FedEx. We typically would charge $400 for this eCopy service. After the unofficial policy change, all of our 510k submissions consist of a paper copy of the cover letter and an eCopy on a USB flash drive. We only charge $150 for the new eCopy service, and 100% of our eCopy submissions have been uploaded without problems.
The FDA eCopy is required for 510k submissions, pre-submission requests, q-sub meeting minutes and De Novo applications. These submissions vary in size from < 50 pages to greater than 3,000 pages. Pre-submission requests and meeting minutes from a q-sub meeting are generally < 100 pages. Due to the unofficial change to the eCopy submission policy, now all of our eCopy submissions are delivered to the FDA overnight for a flat fee of $150/each. This pricing includes a paper copy of your signed Cover Letter and a USB flash drive with your eCopy, validation that your eCopy will pass the eCopy requirements and the cost of overnight shipping via FedEx from our offices to the FDA.
To Purchase FDA eCopy Services Now
Please assemble your submission in compliance with the eCopy guidance requirements, and share the eCopy with us using one of four methods:
- Email the files to firstname.lastname@example.org (only for non-volume based submissions that are less than 10 MB in total).
- Create a zip folder with your folders and/or files, and send them to email@example.com using the free WeTransfer service (only for submissions less than 2 MB).
- Upload the folders and/or files to Dropbox and share with firstname.lastname@example.org. I can also share a folder I create with you and then you can upload the content.
- Upload the folders and/or files to Google 1, formerly known as Google Drive, and share with email@example.com.
Pricing is a flat fee of $150. This includes the cost of printing a paper copy of your signed cover letter, creating an eCopy, validation of the eCopy and shipping overnight via FedEx.
If you have a PDF report from a testing lab that has a file size that is more than 50MB, you will need to split the file into multiple files. If you have non-PDF files that need to be included (e.g., Excel spreadsheets or videos), you will need to place the files in a “MISC FILES” or “STATISTICAL DATA” folder. If the total size of your submission exceeds 1GB, you may want to split your eCopy or provide multiple copies so that the FDA Document Control Center (DCC) can upload our submission more quickly. If you need any help with this, please contact us. There is no additional charge for < 15 minutes of our assistance–and our service is faster and cheaper (i.e., $150) than shipping from Europe to the USA. If you need urgent help to meet a deadline, please text Rob Packard @ +1.802.258.1881.
If you need more help, our hourly consulting rate is provided on the Standard Pricing Sheet. We can review your submission for potential corrections or improvements needed. We can complete and an RTA checklist for you to ensure that there are no obvious missing elements that would result in your submission being rejected during the RTA screening, we can help you convert files to PDF documents and we can help you address any deficiencies already identified by the FDA prior to re-submission.
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.