Is it time to scrap the DHF, DMR and DHR?

To successfully navigate an inspection by FDA, it’s essential to maintain three separate buckets for your device files: the Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR). However, with the upcoming update to the US Quality System Regulation, these terms may no longer be used.

Since 2018, the FDA has been working to align its Quality System Regulation QSR 21 Part 820 with the global standard for Quality Management Systems, ISO 13485:2016. And this is for a very good reason. The FDA played a key role in developing this standard and is also a member of the Medical Device Single Audit Program (MDSAP)accepting audit reports from MDSAP-recognized Auditing Organizations instead of FDA audits.

The implementation of this new regulation, Quality Management System Regulation (QMSR)  has however faced repeated delays. But in May 2023 Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH) stated that the publication of the QSMR is a “high priority” for the FDA and should be out by the end of this year. So maybe the new QSMR will be a long-anticipated Christmas present.

The new regulation will eliminate most of the requirements in the current Part 820. Changes in the QSMR will primarily be made by referencing ISO 13485 rather than duplicating the exact text of the standard. However, some sections will include clarifications, and it’s crucial to remember that the other regulatory requirements will still apply. For instance:

  • 21 CFR Part 830: Unique Device Identification Requirements
  • 21 CFR Part 821: Traceability Requirements, if applicable
  • 21 CFR Part 803: Reporting to Regulatory Authorities
  • 21 CFR Part 806, Advisory Notices

A significant difference between the QS regulation and ISO 13485 is that the risk management requirements are integrated throughout all aspects of the quality management system in ISO 13485. This contrasts with 21 CFR 820, where the risk-specific requirements are only listed in §820.30(g) as part of design validation.

If you’re already ISO 13485 certified, changes to your system will be minimal. If you only operate within the US, changes will be more substantial.  If you plan to remain solely within the US, you don’t need to obtain a notified body or 13485 certifications. You can continue as before but follow the QMSR instead of the QSR. The FDA will continue its usual site inspections but will use its new audit method based on QMSR (i.e., ISO 13485) instead of QSIT.

It’s important to note that an inspection from FDA won’t result in a 13485 certificate since this is a government inspection and not a Notified Body audit. It’s also crucial to understand that even if you already have a 13485 certificate, the FDA will continue to inspect your site as long as you sell in the US, unless you participate in the MDSAP audit program.

While it’s uncertain whether the QMSR will indeed be published by the end of 2023, we will certainly keep a close watch on this development and hope that “a watched pot never boils” proves to be incorrect in this case.

In the next follow up article we will go through the major differences between the ISO 13485:2016 and the proposed QSMR.

If you have any question, contact us at info@qadvis.com.

Follow us on LinkedIn!

FDA issues a new version of ISO 10993-1 guidance, which impact devices with intact skin contact

In September 2023, FDA released a new version of their guidance “Use of International Standard ISO 10993-1”.

In this version FDA guidance document , it is stated that:

  • FDA agrees with the ISO 10993-1:2018 revision regarding focus on minimizing the “number and exposure of test animals by giving preference to in vitro models and to chemical, physical, morphological, and topographical characterization testing, in situations where these methods yield equally relevant information to that obtained from in vivo models.”

The updated version also contains a policy for a least burdensome approach for devices that have intact skin contacting materials that are made from specific synthetic polymers and natural fabrics. FDA recommends that for these devices, specific material information is included in the premarket submission (PMAs, HDE applications, IDE applications, 510(k)s and De Novo requests) in lieu of biocompatibility testing. The approach also relies on certain parts of the QSR and post market controls to identify potential biocompatibility-related issues.

If you have any questions or need more support don’t hesitate to contact us at info@qadvis.com

Follow us on LinkedIn!

Medicinteknikdagarna 2023

Upplever du att de medicintekniska regelverken är lite krångliga och ibland svåra att navigera i, kom och prata med oss. Vi finns i monter 113.

Vi är glada att få vara med som utställare på årets upplaga av Medicinteknikdagarna (MTD) som anordnas av Medicintekniska föreningen (MTF). Utställningen kommer vara på BioClinicum-Nya Karolinska Solna och ni hittar oss i monter 113.

MTD samlar flera olika aktörer och intressenter som på något sätt har en koppling till medicintekniska produkter. Det känns därför extra bra att få vara på plats och ta del av diskussioner om AI-tillämpningar, innovation och digitala lösningar och andra diskussioner som förs i branschen just nu. Med vår kompetens och förståelse kan vi på ett effektivt sätt bidra med den regulatoriska analysen och hjälpa till att identifiera vilka aktiviteter som behövs för CE-märkning av den medicintekniska produkter. Inte minst med avseende på kraven för egentillverkning som med MDR 2017/745 och IVDR 2017/746 är tydligare reglerat.

Follow us on LinkedIn!

Do you remember the FDA eSubmitter?

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

Follow us on LinkedIn!