Відео

Agreed, but until you have done an investigation that involves a serious injury or death, we don't always believe it can happen.

@@MedicalDeviceAcademy Which is a shame really. Yet it's sadly the truth of the matter.

Thank you. Looking forward to working with you.

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.

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.

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.

Agreed, but we do not see testing labs encouraging companies to do this.

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/

Yes, we conducted a webinar on this topic in February: medicaldeviceacademy.com/21-cfr-820/

Maybe its threat analysis?

The term was "threat analysis." It refers to analysis of potential software and hardware vulnerabilities that can be exploited by cyber attacks.

Correct.

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.

Thank you for the request. Which process should I demonstrate next?

​@@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

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/

Thank you for answering my question!

Yes, this is usually the focus of pre-submission questions that are specific to the topic of "Indications for Use."

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.

Great suggestions. I scheduled a live-streaming session for tomorrow morning @ 9am ET. The topic is Design and Development. Thank you :)

@@MedicalDeviceAcademy Thank you Rob, waiting for more :)

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.

@@MedicalDeviceAcademy Thank you Rob. really appreciate it

You're so welcome!

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

Correct as always. Thank you Matthew.

You are most welcome.

It is fascinating how we can automate tasks with software, but we can also do stupid things faster.

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).

You bet!

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.

@@MedicalDeviceAcademy 😁 that’s exactly what i needed to know! Thank you again.

I think so too!

The FDA loves acronyms.

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.

You're welcome.

Yes they do. Once there was a slight decline, because there is inflation adjustment.

Yes, if you are a US-subsidiary you need to make sure the parent company is included in your small business application as an affiliate company.

@@MedicalDeviceAcademy what exactly is a parent or sister company?

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.