Welcome to the 510k Frequently Asked Questions page. What do you want to learn in Amsterdam? Please check back often as this is a living document that grows as we receive and answer more questions. If you have any new questions that you would like to ask, please leave a comment or email President, Robert Packard at rob@13485cert.com.
Seats are limited for the 510k workshop in Amsterdam, if you would like to reserve your seat please click on the link HERE.
510k Frequently Asked Questions and Answers
The 510k frequently asked questions page provides an interactive opportunity to learn more about the upcoming 510k workshop in Amsterdam on October. If you would like to find out more and participate, please register for our Free FAQs Webinar!
510k Frequently Asked Questions: 1 – When is the Workshop?
On October 11-12. The Amsterdam 510k Workshop begins at 9am, and registration begins at 8am. A networking lunch is included in the City Cafe. Attendees receive a physical copy of the presentation slide deck, a hardcopy of the book “How to Prepare Your 510k in 100 Days,” and a flash drive with a complete set of 510k document templates. More important than what you receive, is what you will learn.
510k Frequently Asked Questions: 2 – Where is the Workshop being held?
Oosterdoksstraat 4, Amsterdam, 1011 DK, Netherlands
Call for Directions & Reservations: +31-20-5300800
Click on the picture in order to get reduced hotel rates when you register – Starting at 224€
510k Frequently Asked Questions: 3 – How to reserve your seat?
Follow the link in the picture below for instructions on how to register! Alternatively you may email Robert Packard at rob@13485cert.com with a request to submit an invoice to you for registration, or via PayPal using the link.
510k Frequently Asked Questions: 4 – What topics are going to be covered?
Rather than spend a little time on every aspect of a 510k submission, instead I will be focusing on the most important parts of a 510k submission with stories, examples and exercises. Our speakers will cover:
- How to select a predicate device – Robert Packard
- How to write the indications for use (Section 4)
- How to create a testing plan – Mary Vater
- How to manage your 510k project
- Biocompatibility (Section 15)
- Software Validation (Section 16)
- Electrical Safety & EMC Testing (Section 17) – presented by Leo Eisner
- Human Factors Testing (Sections 13 & 18) – presented by Adam Shames
- Clinical Study Testing (Section 20) – presented by Niels van Tienen
Niels will be teaching a free webinar on the topic of clinical studies on Wednesday, August 9th @ 10:00am EDT.
We will be collecting specific questions from registrants in advance to ensure that we include the areas that are most important to you. We have content from 24 webinars, covering each section of a 510k submission, and templates for each document. Therefore, we can review any section of a 510k in detail.
510k Frequently Asked Questions: 5 – Who are the speakers and sponsors?
- Medical Device Academy, Inc.
Medical Device Academy is a consulting firm that helps medical device companies with regulatory submissions, establishing new quality systems, internal/supplier auditing and training.
FDA eCopy is a service provided to device manufacturers and other regulatory consultants to help prepare, review, edit, print and ship FDA eCopy submisisons. We routinely prepare, review, edit, print and ship 510(k) submissions and pre-subs to the FDA with overnight FedEx shipping.
Factory-CRO is a global clinical research organization (CRO) that specializes in medical device and IVD clinical studies. The company manages clinical studies in Europe for CE marking and in the USA for FDA submissions. For more information, please download the company information sheet.
510k Frequently Asked Questions: 6 – What is the eCopy submission procedure for the FDA?
The FDA has an eCopy guidance document for submissions to CDRH.
The process is not difficult, but preparation requires attention to detail. If you make a mistake, the FDA will not be able to upload your file and it will not be accepted.
Last year I had one week where I had a problem caused by a Windows 10 upgrade that caused 6 submissions to fail in the same week. After that I spent a few months solving every single FDA eCopy problem there is, and I created a new consulting service: http://www.fdaecopy.com.
The FDA eCopy service I offer costs less than the shipping and printing costs that are included in the price, and if you are shipping to the FDA from outside the USA, the FDA eCopy service is less than the shipping costs alone.
510k Frequently Asked Questions: 7 – If customers use a product off-label and voluntary contribute their results to a device manufacturer, can that data be used as a retrospective clinical study to support a 510k in which the new device differs in composition but not mode of action from the predicate?
Off label use and clinical trials do not go well together. You need an IDE, FDA approval in US or Ministry of Health approval in EU before you commence a clinical trial for a device that is not cleared (510k) or approved (PMA) or bares CE Mark (EU).
Most 510(k) submissions do not require a clinical study, but 10-15% of 510(k) submissions require clinical data and clinical data is always required for expanded indications that were not cleared for the device or the predicate device.
Additional information:
To take advantage of lower study costs outside the USA, many companies will perform their study in Europe. OUS studies do not require an IDE submission, even if the study represents a significant risk, because the study is being performed outside the USA (OUS). However, the study will require pre-approval of the clinical study in the country where the study is performed and approval of the ethics review board.
Even though you don’t need IDE approval, you should always submit an FDA pre-sub meeting request to make sure that your data is accepted. In the pre-sub meeting you can ask questions about the overall study design, your rationale of the statistical sampling size and study endpoints. If you are conducting multiple studies, you will need to address any differences in the study designs beforehand to make sure that the FDA will not exclude some of your data as meta-analysis.
If there are human factors issues in the use of your product, you may need a separate human factors study to demonstrate that your device will be used correctly by representative users. The FDA will not accept the human factors studies from outside the USA, because the users are not representative of the users in the USA.
The FDA also published a guidance document in August 2015 to specifically addressing this question.
510k Frequently Asked Questions: 8- Are foreign (non-US) clinical data acceptable for 510k submission? if yes, should these foreign clinical studies be “endorsed” beforehand by FDA (i.e. do they require an IDE submission) ?
Most 510(k) submissions do not require a clinical study, but 10-15% of 510(k) submissions require clinical data and clinical data is always required for expanded indications that were not cleared for the predicate device. To take advantage of lower study costs outside the USA, many companies will perform their study in Europe. OUS studies do not require an IDE submission, even if the study represents a significant risk, because the study is being performed outside the USA (OUS). However, the study will require pre-approval of the clinical study in the country where the study is performed and approval of the ethics review board.
Even though you don’t need IDE approval, you should always submit an FDA pre-sub meeting request to make sure that your data is accepted. In the pre-sub meeting you can ask questions about the overall study design, your rationale of the statistical sampling size and study endpoints. If you are conducting multiple studies, you will need to address any differences in the study designs beforehand to make sure that the FDA will not exclude some of your data as meta-analysis.
If there are human factors issues in the use of your product, you may need a separate human factors study to demonstrate that your device will be used correctly by representative users. The FDA will not accept the human factors studies from outside the USA, because the users are not representative of the users in the USA.
The FDA also published a guidance document in August 2015 to specifically addressing this question.