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?

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.

The FDA eSTAR help indicates that they prefer machine readable version, but I have seen both. The FDA also references a guidance on SBOMs.

Thank you. You are correct. Here's the link: www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-software-use-medical-devices

Yes, Google Drive would have the same issue. I have seen bridge software to enable Microsoft Word and Google Docs to create an audit trail so it can be validated, but it costs money and time.

Yes, exactly. The first company to be granted the De Novo is the only company to be granted De Novo. It has nothing to do with when you submitted it. It is when the FDA makes its decision. There will be delays in the review process and each company will have to respond to requests for additional information. The slower you respond, the more likely someone else will get their De Novo granted first. If this happens, you do not get a refund. You have to change your submission to a 510(k) and pay a new user fee.

Try asking clinicians. A clinical expert is the best person to ask. Your sales team should also know, because they are often asked how your device compares with competitor products.

Nobody likes to fill in surveys, but automation of survey delivery and timing the delivery of surveys to immediately after use is the key to higher response rates. Shorter surveys help too. If you randomize which questions are asked you can cover all of your questions cumulatively--even though each person is only answering some of your questions. Finally, if you want to use your PMS data for a US submission, make sure you look at 522 plans as examples and ask the FDA for feedback in a pre-submission.

No the FDA is not accepting 510(k) submissions in the eCopy format anymore. That ended October 1 of 2023. The FDA eCopy is limited to SIR meeting requests, sprints, meeting minutes, and a few other types of submissions. You can submit an AI Response using the eCopy, but the preferred response is to resubmit the FDA eSTAR with "additional information" selected instead of "new submission" selected.

You are absolutely correct that there is no "1345" standard. We are just used to saying it so quickly that we pronounce the standard's number too quickly. Americans often poke fun at British speakers for being too formal in their diction, but this is a great example of why good diction is important. This is also how you can tell when a singer has been trained properly. My apologies for my lazy tongue, but I fear that this poor habit will not die after 20 years.

In the examples provided in ISO/TR 24971:2020, specifically Clause 5.5, there are examples of qualitative, quantitative, and semi-quantitative estimation of risks. You could use either approach. Before the risk management team begins the risk estimation process, the team should agree on a scale to use (a scale of 1-5 is most popular). This should be documented in your risk management file. In addition, the scores will need to be reviewed whenever you receive post-market feedback. The PMS data may indicate that your original scoring was inaccurate and should be revised. You should not use the term "classification" for risk estimates or the components of severity or probability, but it is ok to use qualitative estimates with the words high, medium, and low. The term "classification" should be reserved for things like software risk classification (i.e., A, B, C) or device risk classification (i.e., 1, 2, 3 or 1M, 1S, 1R, 2a, 2b, and 3).

@@MedicalDeviceAcademy Thank you!

You should identify each hazard separately in your risk analysis. For each harm you will estimate severity and probability. Many times companies will only focus on the most severe harm or most severe risk. However, when risk controls are implemented, the probability can change, and in post-market surveillance, we find that our original estimated harms and probabilities might not be accurate. If we limited our estimation of harm and probability to only one possible harm or hazardous situation, we might find out later that our risk analysis is missing critical residual risks that need to be disclosed to users and patients.

My pleasure!

Thank you for watching our videos. Unfortunately, we don't handle drug, cosmetic, or food regulations. Our business is strictly medical device regulations.

There is an entire annex in ISO/TR 24971:2020 that is dedicated to this. The annex explains the relation ship between regulations, standards, and stakeholder requirements. Therefore, companies need to write their own risk management policy specifying how risk acceptability is determined. This is one of the major clarification items that was undertaken by the committee that revised ISO 14971 and ISO/TR 24971.

@@MedicalDeviceAcademy thank you for your reply, I did go through the standard iso 24971 of annexe C which explains about relationship between risk policy, acceptability criteria, but im not still sure about how to draft a risk acceptability criteria. Does it simply means to set qualitative or quantitative parameters for severity and probability?

Regulators are not especially adept at wording requirements so that they will be "future proof." Eventually, companies will realize that incorporating usability activities in the design and development process is just as important as including risk management activities. It may take another generation or two, but it will happen. Until then, we will be stuck with ISO 13485:2016 as written.

Although the QSR does not include human factors or usability, the QMSR that goes into effect on February 26, 2026 will incorporate ISO 13485:2016 by reference. In Clause 7.3.3 (i.e., Design Inputs), the IEC 63266-1 standard is referenced. Therefore, companies are expected to establish use specifications and user interface specifications as part of the design process and these specifications would be verified and validated. In other countries, the requirements to include usability are specifically indicated as an essential principle of safety and performance.

The country of origin requirements for labeling are outside of the scope of US FDA regulations, and they are different in every country. Therefore, this is not something I can provide a video on. However, there are other videos on KZfaq about country of origin. In general, in the USA the expectation is that "Made in the USA" means that the origin of the raw materials and the labor is the USA, while other countries use the more literal terminology to specify the origin of the labor only.

medicaldeviceacademy.com/recall-procedure/ - The webinar was recorded on Jul 17, 2024. We had a schedule conflict on the 25th.