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 are presenting an updated live webinar about eCopies on Wednesday, August 30, 2017 @ 10:00am EDT. 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)
Pricing of FDA eCopy services
An FDA “eCopy” is an electronic copy that must be shipped with a physical hard copy of your submission. 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. Therefore, we prepare, validation, print and ship your pre-submissions and q-sub meeting minutes for a flat fee of $150/each. For 510k submissions and De Novo applications, the submission are general > 500 pages at a minimum. Therefore, we charge a flat fee of $250 for these FDA eCopies and then we add a per page charge of $0.15/page for black and white copies and $0.30/page for color copies. This pricing includes the binder(s), paper, dividers between sections, printing, 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 for a Pre-Sub
A pre-submission request typically consists of 10-15 documents. Therefore, you can simplify the organization of your pre-submissions by using a single volume structure. Often divider tabs are not needed for a pre-submission request either if you clearly paginate the document and provide a table of contents. If you need any help with this, please let us know. Usually there is no additional charge for our assistance–and our service is faster and cheaper (i.e., $150) than shipping from Europe to the USA.
Pricing is a flat fee of $150. This includes the cost of shipping overnight via FedEx, binder, divider tabs (if needed), paper, printing, flash drive, eCopy validation and labor. All pre-subs will be printed “autocolor” so that any pages in color will be printed in color.
Unless you opt for an email response to your pre-submission request, you are required to provide draft meeting minutes to the FDA within 15 days of your pre-submission meeting. The meeting minutes are typically 1-3 pages in length, but the FDA will also want you to provide a copy of any slides you presented during your pre-submission meeting. These two documents can easily be combined into one PDF and submitted as a single document FDA eCopy. This takes very little time to prepare, validate, print and ship (< 15 minutes at a hotel business center). However, if your company is located outside the USA, it’s still less expensive (i.e., $150) for our company to ship it to the FDA for you.
Pricing is a flat fee of $150. This includes the cost of shipping overnight via FedEx, binder, divider tabs (if needed), paper, printing, flash drive, eCopy validation and labor. All pre-sub meeting minutes will be printed “autocolor” so that any pages in color will be printed in color.
To Purchase FDA eCopy Services Now for a Pre-Sub
Note: You need to purchase the the first product below and at least one of the other two per-page products to pay for your FDA eCopy services on-line. Most printed copies are in black and white–except for sections of documents where color is needed–such as color coded graphs in testing reports. You should email us which pages or sections should be color printed when you place your order You can also provide a separate Word document in the Dropbox folder with printing instructions.
Pricing is $250 + $0.15/page (B&W) + $0.30/page (Color). This includes the cost of shipping overnight via FedEx, binder(s), divider tabs, paper, printing, flash drive, eCopy validation and labor. B&W and Color Pages are ordered separately below.
Pricing is $250 + $0.15/page (B&W) + $0.30/page (Color). Please specify the number of B&W Pages here.
Pricing is $250 + $0.15/page (B&W) + $0.30/page (Color). Please specify the number of color pages here.
If your submission is more than 500 pages, we will probably need to split your submission into multiple binders. It is helpful if you decide where you want the submission split into binders and indicate this in the table of contents. If you would like us to do that for you, please provide a Word version of your table of contents and we will send you a PDF proof of the revised table of contents before printing and shipping the FDA eCopy.
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.