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.
The FDA eCopy webinar and our 510(k) Cover Letter template have been updated to reflect the new FDA eCopy guidance requirements that were released on December 16, 2019.
Temporary Reduction of eCopy Fee to Help Anyone Under COVID-19 Quarantine
Some of our customers, and one of our employees, are subject to stay-at-home orders. In some countries, the quarantine is nationwide. Medical Device Academy’s office is in a rural area of Vermont and we should be able to continue deliveries to the local FedEx office for quite a while–if not indefinitely. For now the FDA is still accepting shipments to the document center (but we will let everyone know when and if that changes). Therefore, if you have an eCopy you need to ship, we are temporarily reducing our fee for an FDA eCopy from $150 to $99. If you want us to complete an NDA, please don’t hesitate to send your NDA to me at email@example.com. The business is an Indiana Corporation with principal office address located at: Medical Device Academy, Inc. 345 Lincoln Hill Rd., Shrewsbury, VT 05738 USA. I can also send you a free template for your eCopy cover letter if you need one.
When is the FDA 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. Over time, the FDA made additional changes to their policy and a new guidance was released on December 16, 2019 and we recorded a new webinar on December 27, 2019. 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 the 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 the new FDA eCopy guidance and our cover letter template for eCopies. Additional questions can be asked at any time by sending me an email or scheduling a call on my contact us page. You can also read our new blog explaining the changes in the new eCopy guidance.
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 FDA eCopy service was launched, and the first customers hired us to help them with printing and shipping their FDA submissions.
Updated 2019 Pricing of Our 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. The new 2019 eCopy guidance documents this policy which is now official.
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 6,000 pages. Pre-submission requests and meeting minutes from a q-sub meeting are generally < 100 pages. Due to the official change to the eCopy submission policy, now all of our eCopy submissions are delivered to the FDA overnight for a flat fee of $99/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., $99) 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.