Over the years, the FDA has had several 510(k) submission programs to make the process more streamlined and effective.

This was achieved by going from paper systems to e-copies, e–submitter and Electronic Submission Gateways (ESG).

In 2021, eSubmitter was discontinued after the eSTAR Pilot Program was launched in 2020.

So far, eSTAR has been voluntary but from October 1, 2023, eSTAR will be mandatory for all 510(k) submissions.

The electronic Submission Template And Resource (eSTAR) program launched by the FDA is intended to enhance the quality of submissions for medical devices by helping to ensure submitters provide quality, comprehensive data for premarket review. The eStar program is currently voluntary, but starting October 1, 2023, all 510(k) submissions, unless otherwise exempted must be submitted as electronic submissions using eSTAR.

The eSTAR is an interactive PDF form that guides you through the process of preparing a 510(k) or De Novo request. Also note that since the e-STAR uses automatic verification, the FDA does not intend to conduct a Refuse to Accept (RTA) review for eSTAR submissions.

FDA has also provided an updated guidance for Electronic Submission Template for Medical Device 510(k) Submissions that outlines the process for additional help.

So, what do you need to know about this interactive pdf?
Well, first you need Adobe professional to be able to fill in data. It won’t open in your web-browser, so you must download the pdf to your computer to be able to use the program. When you open it for the first time it might be surprising that it is only 3 pages long. But have no fear, as you move along and tick checkboxes, new pages will open. It’s like an adventure in Dungeons and Dragons. And for each section you have the possibility to add attachments. If possible, add only 1 (document) attachment in each section to make the review easier to handle. But you can attach various types of files, including video.

As you fill in each row in the respective section, the banner on the left in the template goes from red to green. When the entire section is completed, the top banner goes green as well. You are now ready to go to the next level.

A practical approach with regards to collection of the supporting documents – do not attach draft version of your pdf since you will not be able to edit them once attached. A recommendation is to keep them in a separate folder until they are approved and valid. If you need to change a file already attached, you must delete the file and attach the new one.

Compared to the previous 510(k) submissions template, eSTAR is a giant leap forward and seems to be very user friendly. If weshould say something less positive about the program, is that it sometime takes a while for the pdf to process the information and open the next section. But not to the extent that it poses an actual problem.

Generally, regulatory updates cause additional work and make life in general more challenging for manufacturers, but in this case, it nearly makes a 510(k) submission fun. Or is it just us?

If you have any questions or want to know more, don’t hesitate to send us an email info@qadvis.com

The above is a quote from Peter Drucker (1909 – 2005) the founding father of modern management studies. And nothing could be more true, especially if you decide to start a business in the medical device consulting industry.

That is exactly what Robert Ginsberg and Nils-Åke Lindberg did in 2013 when they founded QAdvis AB.

It is said that the first year of a dog’s life is roughly fifteen human years. The second year is nine years and each additional year four or five years. In a way the same can be said for companies. The first years are dog years for all companies, but in the medical device sector the dog life never stops, the fast development of technology accompanied by updated regulations makes you feel like each year is at least five years all the time. You can never relax thinking “I got this” since the only constant is change. The ground you are standing on is always moving and your knowledge and methods must evolve and follow. This is the environment in which the seed of QAdvis was planted and has grown ever since.

Since 2013 the world has seen tremendous change, in Sweden alone the population has increased with nearly a million people and the petrol prices has increased by 45%. In the medical device field, the changes have been even bigger. ISO 13485:2003 was replaced by the 2016 edition, and the Medical Device Regulation and the In Vitro Diagnostic Regulation replaced the MDD and the IVDD respectively, which was the single biggest change for medical devices and invitro diagnostics in 20 years. The fast development of software also initiated the IMDRF to release the first guidance for Software as a Medical Device (SaMD) in 2013, and the development of software and especially AI has since then exploded. In addition, we’ve seen Canada discontinue the CMDCAS and adopt MDSAP, we’ve seen Brexit as well as the breakdown of the MRA between EU and Switzerland leading to the introduction of UKRP and CH-REP.

And all these changes were made to the living and breathing medical device industry. Like doing knee-surgery during a marathon, or like that episode “Wrong Trousers” in the British stop-motion animated comedy “Wallace & Gromit” where  the anthropomorphic beagle Gromit is sitting on a full speed toy train and building the tracks in front of him as he goes, simultaneously navigating through treacherous surroundings.

In such a changing world, the need for knowledge of what to do and how to do it, was and is insatiable. Knowledge, although necessary, is however not enough. Even very knowledgeable people will fail if they fail to understand the needs of the customer. With that in mind, QAdvis decided to employ seasoned “humble experts” with a deep understanding of customer needs building the foundation for our “solution-oriented knowledge” approach. This has turned out to be a winning concept. Since 2013 the revenue has increased by 200% and the number of employees is continuously growing and today, we have offices in two countries and customers in many more.

This is an exceptional growth and QAdvis was therefore awarded Gasell Company of the year 2021 by Dagens Industri, the biggest daily business paper in the Nordic countries. To quote the founders’ words at the time “We have no ambition to be the biggest, but we for sure want to be the best.”

Now that we celebrate our 10^th anniversary, or 59^th anniversary in dog years, we look back on 10 years of success for us and our customers, and we are looking forward with anticipation to the next 10 years and the future.