Medical Device Academy is a full-service QA/RA consulting firm for medical devices. Our goal is to help startup companies get their first device to market. We know you have a limited budget, so we post free training videos on this channel in addition to our paid webinars. On our website, we have a complete turnkey quality system for sale: medicaldeviceacademy.com/. We have dozens of clients from other countries that we are helping to obtain 510(k) clearance and to implement a quality system compliant with ISO 13485:2016 and applicable national regulations. We now offer FDA US Agent services at: fda-us-agent.com/. Live-streaming videos are hosted on this channel every Friday at 12:30 pm Eastern. If you have a topic you want us to talk about, please leave a comment under our discussion tab. Please don't forget to share videos with colleagues you think would benefit from our content.
Hi Rob, thanks for the video, just a suggestion to make a new video on this topic to align with the requirements for eIFU per the regulation 2021/2226, and any other new information
I want to clarify I understand this. To be GMP exempt means that the device is exempt from quality system requirements except for what's in 820.180 and 820.198. Is that correct?
24:05 is it 510K submission? I thought it is only class 1 devices that are only exempted from the design control requirements except for the class 1 devices listed under 21 CFR 820.30
Hi Rob, great video but I think I'm still a bit confused. Could you please explain if the Establishment Registration and FDA User fee are the same thing? Thanks!
Thank you for the great video, I was looking into this topic and your video answered most of my questions, however, would you please clarify the following: 1. Do we need to check the list of technical files and list of risk management files for both second-party audits and certification audits? 2. Should the adequacy of risk management files be assessed during the annual planned QMS internal audit, or only during management review? 3. If there have been no changes to the risk management plan since the last approval, should it still be re-issued as per procedure, even if it's typically the same as the last one? Additionally, do we need a post-market surveillance plan for a CE-certified medical device that has not been marketed for two years after getting CE certified under the new MDR, the initial risk management plan was submitted as part of the technical documentation submission? Similarly do we need the same for PMS plan in the same situation?
Here is the takeout: 1. Review the risk management procedure and any associated work instructions. 2. Request a copy of the risk management plan in advance, as it serves as a roadmap and should outline the frequency of plan review. 3. Ensure that the company conducts both Failure Mode (FMEA) as well as hazard analysis as per ISO 14971 standards. 4. Verify the identified measures for eliminating and controlling risks. 5. Check for post-market surveillance activities. 6. Ensure that benefit-risk analysis is performed according to the Medical Device Regulation (MDR) requirements, including for low-risk products. 7. Review the risk management report, which summarizes all risk management activities and not all risks. 8. Identify the triggers for updating risk controls.
Hi Rob, thank you for another great educational video for MD professionals, my question is: If Device Master Record (DMR) in the US is equivalent to technical files in the EU, what would be the equivalence to Design History File (DHF) in the EU? Does this mean that the technical file will include both the DMR and the DHF? Please advise, as it is a bit confusing.
So ISO 13485 is the very foundation of Quality Management Systems and in outlining what pieces you need for it. Is this the same foundation you created your QMS on?
It takes two 20-minute sessions (sometimes a little shorter and sometimes a little longer). In between the two sessions, you need 48 hours for your user fee payment to clear with the FDA.
This was great-thanks for hosting, Rob. I have a question: If penetration testing identifies cybersecurity vulnerabilities in a mobile medical app, is it necessary to conduct and document a complete impact assessment and regression analysis of the software before implementing the cybersecurity fix? After the issue is resolved, would it be required to develop a regression testing report, or is it sufficient to simply fix the cyber vulnerability and document that it was addressed?
Usually you don't want to submit software for pen testing until it is "bug free." So the last thing you are probably going to do is validate the software to make sure your last few bugs are gone. But you don't need an impact assessment and regression analysis before you submit the software for pen testing. After vulnerability testing and pen testing are completed, you will have a new list of things to fix. After you fix the security issues, you should probably repeat your validation again before sending it back for pen testing. This would be the logical time to develop your validation testing report, but you could also do it after the final security testing. Hopefully, the second time the security issues are gone and you don't have to repeat the process a third time.
Always get a good night's sleep. Your ability to communicate and remember information that the auditor is asking for is greatly impaired by a lack of sleep. Your memory would be substantially better if you had 8 hours of sleep and you will have greater patience for speaking with an auditor when they are defensive.
Hi Rob, As we've been working on eSTAR, we've noticed that some critical sections, such as the Risk Assessment and Device Hazard sections, seem to be missing. Could you please guide us on how we might submit this additional information? Thank you for your assistance.
Certain sections of the FDA eSTAR are not used in 510(k) submissions. The eSTAR is intended for three types of submissions: 1) 510(k), 2) De Novo, and 3) PMA. The risk and hazard sections only appear for De Novo and PMA submissions.
Most companies choose to submit a pre-sub first, and they only submit a 513(g) if the FDA refuses to answer the question of regulatory classification in a pre-sub. Therefore, the earlier the first pre-sub is submitted, the sooner you can determine if a 513(g) is going to be needed or not.
What kind of documents would you not want an FDA inspector see? Especially since it seems the FDA has a way to be able to access most documents anyways.
Some people try to hide things from inspectors, but that strategy is usually counter-productive. FDA inspectors are trained to look for companies that are trying to conceal things from them. Usually, the best approach is to share information with inspectors to show that you want to do the right thing and you don't have anything to hide. We also have a webinar and work instruction explaining how to handle FDA inspections: medicaldeviceacademy.com/fda-inspection-webinar/
Hey, I just stumbled upon your videos and they're honestly amazing. Here's my question here. Let's say I did do planning, and even documented it. However, it was never done in a single document. Nor was it always done in text form (often video logs). Am i allowed to create a design document that I write retroactively? Because what's done is done at this point, and I learned my lesson. But how do I fix it?
Yes, you can create the design documents retroactively. We usually recommend using AI notetaking to transcribe meetings. This makes it easier to edit and copy/paste information into forms used for your design history file.
A huge thank you for making this video as requested, and I really appreciate you taking the time to put it together. I gained so much from it and it’s already making a big difference for us. Keep up the amazing work!
@@MedicalDeviceAcademy Thank you, can you do the next one on the topics of Sterilization controls/monitoring, Infrastructure, work environment and environmental controls, Cleanroom qualification/maintenance, I hope it can fit into one video, if you think it should not be in one video, please do what you deem is right
This video was incredibly helpful! It gives a clear understanding of how audits should be performed. The step-by-step explanation and real-world examples made the concepts much easier to grasp. Thank you for creating such an informative and well-organized resource!
Thank you so much for the positive feedback. I only wish my handwriting was better. Please stay tuned for future demonstrations of how to perform a process audit.
I believe the device type you are referring to is an ultrasonic scaler (i.e., "ELC" product code). There are a couple of devices that have been listed as a toothbrush instead of the correct product code, but an ultrasonic scaler is a Class 2 device that requires a 510(k). If you aren't sure if your device falls within this product code, you need to review the description in the regulation: "21 CFR 872.4850 Ultrasonic scaler. (a) Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth." - If you need further assistance, please schedule a call by visiting our contact us page: medicaldeviceacademy.com/contact-us/
One of the comments asked after we ended the session was: "Could you explain the order of how the testing goes?" The order of testing is different for each product--even when you are making a new version of an existing product. The reason for this is usually based upon simple things like logistics (e.g., when are the samples going to be available). If you want to know more about testing plans, please see our webinar on this: medicaldeviceacademy.com/test-plan/
Good to know that a device can have a different intended patient population and use case than its predicate device and be able to justify it to the FDA.
That's one of the reasons quality managers will ask employees to be interviewed during internal audits. They want employees to get some exposure to the process before a 3rd party audit or FDA inspection.
Exactly! Just like design inputs and testing plans. You should identify requirements and testing requirements before you start developing code. In scrum terminology, we call this backlog refinement.
Glad you enjoyed it! If you have suggestions for future webinars or videos, please let us know in the comments or on our website: medicaldeviceacademy.com/suggestion-portal/
@@MedicalDeviceAcademy more software related content please. How to do design freeze and perform V &V while still using agile and iterative development and testing techniques. What test reports to provide under eStar software section and what reports to provide under eStar performance testing, for SaMD vs SiMD. Thanks.
My apologies for not creating a separate slide for "Intended Purpose" as defined for CE Marking. There is an explanation in a MDCG guidance, but the explanation if vague. Therefore, the best way to think of it is: intended purpose = 1) indications for use, 2) intended patient population(s), 3) intended user group(s), and 4) environment of use. All four of these should be in your instructions for use document or user manual.
I am a certified lead auditor and I am still struggling to cover a lot of the requirements. Your videos have helped me tremendously. Would you please continue this series by covering other processes? Watching your videos gives me confidence and a better understanding when auditing "Receiving." It would be great if this could happen for other processes as well, maybe starting with "Design and Development."
I just recently uploaded Remarkable on my new desktop. Therefore, I can create the turtle diagrams for any process flow as part of a live-streaming video--and simultaneously show my webcam feed on the same screen. So it should be even better than that video was. I scheduled a live-streaming session for tomorrow morning @ 9am ET.
We created a test plan webinar to address this question specifically: medicaldeviceacademy.com/test-plan-webinar/ However, the general categories of testing are: 1. biocompatibility 2. sterilization 3. shelf-life 4. distribution 5. reprocessing 6. software 7. cybersecurity 8. wireless coexistence 9. interoperability 10. EMC 11. electrical safety 12. non-clinical performance 13. human factors 14. animal studies 15. human clinical studies
Indications for use are also usually called out in multiple locations of your usability documentation. So if you update in one spot there is usually a need to update it in other locations as well.
Yes, the threshold is annual revenues must be < $100 million. However, this calculation is based upon the cumulative income of parent companies, your company, and subsidiaries. You also have to provide written proof of the amounts each year.
Correct. If the device was cleared but it is not currently registered, then you should contact the FDA in a pre-submission to make sure the FDA doesn't have any concerns with the chosen predicate (e.g., related safety recall).
Thank you Rob. Just attended this Monday webinar and had a question I couldnt get out in time. For Shelf-life extension claims, do I need to notify the FDA when I extend the shelf-life of my device when I'm continuing with the same study that was used during the submission? Can we modify this study a little for future claims? For example, if I want to increase the range of storage temperature, would I need the same amount of samples and lots, or could I reduce this in an additional supportive study?
Thank you Greg. That's a great question. The FDA has said in the past that if we use the same testing method, and the same acceptance criteria, then we can extend the shelf-life without a new submission. This would be following the letter-to-file process for deciding when a device modification requires a new 510(k). If you are decreasing the accelerated aging temperature (40C instead of 50C), or changing the ambient temperature used for real-time aging (15-20C vs 22-25C), this could reduce the deterioration of the parts. The FDA would not permit this change without a new submission. This is why the shelf-life testing must specify a temperature storage range and you need to have records logging the storage temperature throughout the study. If you are using a slightly higher accelerated aging temperature (i.e., 55C instead of 50C) it will increase deterioration of the parts. If you increase the ambient temperature storage temperature for real-time aging (i.e., 25-30C instead of 22-25C), this will also increase the deterioration of the parts. There is a standard for accelerated aging and there is an equation that calculates the simulated aging period, but you need to know exactly what you are doing. If you aren't sure the best approach is to ask the FDA in a pre-submission by providing the revised protocol with a justification for the change, and ask the FDA if a new 510(k) submission would be required to extend the shelf-life.
Love your explanations! Could you please udpate us the link to FDA's 500examples(video min:42:45) I was not able to access to it. Many thanks for your labor
I just tried the database. All of the FOIA links appear to have disappeared since last week. I know I saw links on the database last week, but they are not available right now. Once the FDA fixes this, I will post a follow-up and record a video.
In absolute $, yes it gets larger every year. The discount is a 75% discount for everything but the 513(g). The 513(g) has a 50% discount, and the registration has no discount.
