18 Nov Boston Biomedical Associates Announces FDA eCopy Services
The FDA’s eCopy requirements for medical device regulatory submission has presented a plethora of new challenges and pitfalls for manufacturers who are trying to navigate the FDA’s regulatory process. If a company is not experienced with the process and requirements, a submission can get delayed due to increased preparation time or an eCopy hold in the FDA’s document control center.
Boston Biomedical Associates offers regulatory consulting services to our clients, including eCopy support. We have been successfully maneuvering through the eCopy process since the issuance of the FDA Guidance on October 10, 2013 (The Final Guidance was issued on December 3, 2015). We have an established process for seamlessly guiding our clients through the submission preparation process and once completed we can create the eCopy (or copies depending on the submission type) and submit to the FDA on the client’s behalf.
Utilizing BBA’s extensive experience with the eCopy process is an effective way of ensuring that your submission does not get delayed due to administrative complications or eCopy holds with the FDA.
What is an eCopy?
Per the FDA’s eCopy Guidance “An electronic copy (eCopy) is defined as an exact duplicate of the paper submission, created and submitted on a compact disc (CD), digital video disc (DVD), or a flash drive. An eCopy is accompanied by a paper copy of the signed cover letter and the complete paper submission.” Although this may seem straightforward, this entails a significant number of nuances, such as ensuring compliance with file naming conventions, size limitations, and file structure. BBA follows the process listed below to ensure that the submission does not get delayed in the FDA’s document control center.
- The client sends the files for the submission (can be in word or PDF format) electronically to BBA.
- BBA formats the documents to create a cohesive submission package (i.e. OCR readable PDFs, headers and footers, PDF bookmarks, and ensuring each file meets the FDA’s size requirements)
- The files are organized and named according to FDA eCopy requirements.
- The electronic copy is verified for FDA regulatory compliance using a detailed checklist created by BBA.
- The eCopy is sent to the client for review and approval.
- The document is then printed and bound with labels containing the client’s logo and tabs appropriately identifying attachments or appendices.
- Once complete, one or more eCopies are saved on FDA-accepted digital media.
- The submission package, consisting of the organized paper copy and required number of eCopies, are packaged and shipped to the FDA via an established FedEx shipment process (including daily pick-ups at our office).
- A paper copy and eCopy, identical to the one submitted to the FDA, is also packaged and sent via FedEx to the client.
- FedEx shipment notifications are sent to the client to confirm pickup and delivery of the submission to the FDA.
How long does eCopy Service take?
BBA can offer same day preparation of an FDA submission package (with eCopy) that will be delivered the FDA the next day.
BBA takes pride in the quality of the submission and eCopy packages that we prepare for our clients. We commit to creating a cohesive and finely tuned FDA submission that provides ease of access and navigation by both our client and the FDA reviewers.
Boston Biomedical Associates is ready to help you prepare and submit an FDA submission package (including both paper and eCopy) that will meet the FDA’s document control center requirements. Enabling you to start the FDA review cycle without delay.