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I hope you were referring to the De Novo live-streaming video and not the horrible smoothie.

I hope you liked the live streaming video I just completed. If you have any questions about FDA De Novo submissions, just let me know. The smoothie like thing I was drinking will never exist again (thank goodness, it was nasty).

The software from your suppliers often will also be validated as SOUP, but as you said that is handled differently.

I certainly agree Matthew, but I am starting to see a few software companies start to integrate risk, human factors, and cybersecurity into their development process.

@@MedicalDeviceAcademy Here is one for you. As a 13485 auditor, what would you look for to see a SaaMD company meet 6.4.2. or can that be interpreted as physical contaminants only?

If a device has firmware only, there will be several security controls that the FDA requires that might not be applicable to your device. Then you would explain why those specific risk controls are not applicable. However, if the device with the firmware has no wireless functionality, and no media storage capability, then cybersecurity requirements do not apply at all and the FDA eSTAR will not populate the cybersecurity section. If your device has wireless connections with another device, then you will need to address the risk controls that are possible.

Glad you think so!

I'm happy I was able to provide exactly what you needed. The "official" closing meeting recommendations are found in ISO 19011:2018, but there is no requirement for documentation of what was covered in a closing meeting for internal audits and supplier audits. Therefore, this is an area where you should take advantage of flexibility in the regulatory requirements and customize your closing meeting checklist so you add as much value as possible. It is also an opportunity to impress top management. Practice is important.

That's a very clever idea. I speak quickly and there is a lot of technical jargon. It must be quite a challenge, but this will prepare you well for communicating with English-speaking auditors, inspectors, and other medical device professionals.

Country-specific requirements are at the end of every single task in the MDSAP audit approach: www.fda.gov/media/166672/download

For preventive actions, you are identifying the potential root cause if something eventually became nonconforming. Most people have trouble with this by identifying corrective actions incorrectly as preventive, or they do not identify the potential root cause.

Thank you.

Yes, you are correct. I believe that a hybrid of agile and waterfall is needed for regulatory submissions for this reason. For SaMD you can afford to repeat all of your V&V testing if you make changes, but for SiMD it is not practical (too $$$) to repeat V&V testing iteratively. That is why everyone recommends having a "design freeze."

Wow, thank you! There are 26 other videos on the eSTAR available as part of our 510(k) course: medicaldeviceacademy.com/510k-course/

The person does not need to be a citizen, but they must reside in the USA.

Thank you for the kind praise.

It's not quite clear what you are suggesting. The FDA often asks for more detail in SE comparison tables or corrections if done incorrectly. The 510(k) summary is automatically generated if you use the FDA eSTAR feature, so there is no need to update the 510(k) summary unless you created one manually. I'm not sure why you would be making a change to the Instructions for Use unless you are updating the indications for use. If you are not sure which the reviewer wants you have 10 days to ask clarifying questions when you first receive an AI Hold letter.

Great suggestion. I will do some more. Any specific processes you had in mind?

You're welcome

Thank you Levi. I only wish we had automated tools to reduce the labor of doing the critical review of each article we identify in our literature searches. I know some people that are trying, and ChatGPT will eventually figure out a way.

I do frequently promote our consulting services and webinars, but if you have a question you would like me to answer about shelf-life testing I will do my best to answer.

Why the tears?

😢

I appreciate the love, but I'm not sure why we have also have tears.

I'm not sure we can say that an internal standard has only one purpose. I'm sure Edwin Bills (one of the authors) could list of multiple reasons why we need ISO 14971 (e.g., it is a foundational tool for documenting how electrical safety is ensured for electromedical devices in IEC 60601-1).

The FDA has not provided one, but Medical Device Academy has 3 templates: 1) general for non-IVD, 2) AI SaMD, and 3) IVD products. All three are available as part of our 510(k) course: medicaldeviceacademy.com/510k-course/. However, when new clients kick-off a project with us we give them the appropriate template to start with. We also have blogs and videos explaining how we created the templates in the first place.

You are so welcome!

The US agent is responsible for communications between the FDA and the company. If the company is not cooperating with the FDA in the event of a recall, then the US agent will need to assist the FDA with a recall. I have never seen this happen, but it could. The US agent does not have any control over the company. Therefore, the US agent can't be liable for things the company does.

"Cancellation" of a SCAR is could be interpreted a couple of ways. If the SCAR is closed, you would update your CAPA record to indicate all actions were implemented and the SCAR appears to be effective. Then you close it. You can also send that information to the supplier to include with their CAPA records. Another possibility is that the SCAR was opened and should not have been. In this case, you would amend your CAPA record to explain why it is no longer needed and the record is being closed. If you no longer need a SCAR, do not just delete the record. The CAPA records will be out of sequence and either an auditor or an inspector will ask where the record can be found.

Since your company is already registered, and your first device is already listed, then you just update your listing. You can add the newer version as a brand name to the same listing.

Thank you for this info. I updated the excel file but can not find how to upload it. Is it under the "change" option?

Thank you for the positive feedback. I'm doing a training on risk management and design controls next week at a client, but I'll review my own video again to make sure we share this with them. If you have any suggestions for improvement, please let us know.

For devices that require a 510(k), you are not able to list the device until the 510(k) is issued. Once the 510(k) is issued, you pay the annual registration fee. The FDA will email you the PIN-PCN numbers and then you can complete the registration and listing process. You will have to enter the K number when you list the device. Regarding your question about importers vs distributors, the importer is where product will be shipped first. Therefore, the primary advantage of being an importer is lower shipping costs. The downside of being an importer is that you must pay the FDA user fee for being the initial importer. Essentially, if the volume of sales is great enough it is worth being the initial importer. If the volume is not sufficient, then you only want to be a distributor. Exclusivity and compensation from the manufacturer can impact that financial equation as well.

Most welcome!

I really enjoy all your videos. Thanks for sharing.😊

The particular video you commented on is actually about IEC 62304 and how design controls have changes as agile has be adopted. Most companies now think in terms of the V-diagram instead of the Waterfall diagram for software development. You are correct that the quality system standard is ISO 13485:2016, but I think I probably did not say it clearly enough or spoke too quickly. I also referenced ISO 9001:2015 which is a general quality system standard.

Glad it was helpful!

Glad it was helpful!

Glad you think so!

Glad it was helpful!

You're making work hard. I had to actually look this up. GZJ and NUH are the most common product codes used for a TENS device. IPF and NGX are a couple of other codes commonly used. Usually companies include the electrode with the controller and software as a system under the primary code. However, there are electrodes that are separately cleared via a 510(k). GXY is for cutaneous electrodes. I have also seen people include cables that act as an connection between the controller and the electrode. Cables are 510(k) exempt under the IKD product code. There is also a 3-page FDA guidance on cables and electrode wires: www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/electrosurgical-devices-and-application-performance-standard-electrode-lead-wires-and-patient-cables

You're making work hard. I had to actually look this up. GZJ and NUH are the most common product codes used for a TENS device. IPF and NGX are a couple of other codes commonly used. Usually companies include the electrode with the controller and software as a system under the primary code. However, there are electrodes that are separately cleared via a 510(k). GXY is for cutaneous electrodes. I have also seen people include cables that act as an connection between the controller and the electrode. Cables are 510(k) exempt under the IKD product code. There is also a 3-page FDA guidance on cables and electrode wires: www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/electrosurgical-devices-and-application-performance-standard-electrode-lead-wires-and-patient-cables

Thanks and your hard work is much appreciated brother!

You're very welcome.

Class 1 device are exempt from design controls (i.e., 21 CFR 820.30), unless the device is one of the 5 device types listed in 21 CFR 820.30(a)(2)(ii) listed below or automated with computer software: 1.Catheter, Tracheobronchial Suction 2. Glove, Surgeon's 3. Restraint, Protective 4. System, Applicator, Radionuclide, Manual 5. Source, Radionuclide Teletherapy You also indicated that the device is not GMP exempt. Therefore, all other sections of 21 CFR 820 will apply. There are some typical exceptions (e.g., installation and service do not apply to all devices).

Thank you. I have been teaching this since 2005. The video is our #1 most popular video, but it is 3 years old now. Any suggestions for a remake would be greatly appreciated. I'd like to know how to improve it. What's missing?

Thank you for watching, and I love the comments. Private labeling is a topic people ask about all the time. As a thank you to you, and everyone else that has asked so many questions about private labeling, I'm going to dedicate our next TH-cam live streaming to the topic. Your particular questions needs some qualifiers or assumptions before you can answer it. The primary reason is that the "private label" requirements are different in every country. Your question was about MDSAP certification audits specifically. The MDSAP certification is a variation of ISO 13485:2016 certification that is only required by Health Canada for Canadian licensing. In the USA, the FDA allows people to "private label" in two different ways: 1. "Distributed by" or "Manufactured for" may be used on the label...in this case you are not the manufacturer and you are not the specification developer. You might be the initial importer, complaint file establishment, and distributor. Of the 3 roles, only the distributor is exempt from the registration with the FDA. None of the 3 roles require MDSAP or even ISO 13485 certification in the USA. For the role of initial importer, you have regulatory reporting responsibilities. For the role of complaint file establishment, you have the responsibility to create and maintain complaint records, but the corrective actions would probably be the responsibility of the manufacturer. For the role of distributor, you are responsible for maintaining records of distribution--in case of a potential recall. A full quality system is not required for any of the 3 roles. 2. If you are receiving bulk product from the manufacturer/specification developer, and you are repackaging/relabeling the product, now you will need to add this role to your registration with the FDA. As the repackaging/relabeling company, you must have a quality system, but there are some procedures required in 21 CFR 820 that will not be applicable to your company. Your design control activities will be limited to the label, and in some rare cases the repackager will be placing the product in a sterile barrier package and sterilizing the product. This is more common for kits containing class 1 devices, but I've seen it for class 2 devices as well. If you take on sterile packaging and sterilization you are now doing 90% of the quality system requirements yourself. As I said, MDSAP is not "required" but if you have MDSAP certification, the OEM is a supplier you outsource to. If they have ISO 13485 certification, they probably will not need to be audited by your certification body. Instead you just show your supplier agreements and supplier evaluation of the OEM--along with a copy of their ISO 13485 certification. There are many other possible scenarios, but please schedule a call with me using the contact us page on our website, and I will try to answer the question as it pertains to your specific scenario. Also, please check our our TH-cam live-streaming on April 12.

Thank you so much for taking the time to reply. Very informative and i look forward to your video on april 12.

You have great points. However, when you look at the FDA data for recalls there are very few recalls where the FDA has identified human factors as the root cause of a recall. It used to be that labeling was #1. Now it's software changes. It has never been human factors. There are many AEs that are related to human factors, but it is not the biggest problem. I would like to see the FDA release a new guidance and update eSTAR for human factors requirements--just like they did for cybersecurity. It is the only submission requirement that is not well defined in the eSTAR.

@@MedicalDeviceAcademy yeah my premise was based on a presentation from a compliance lab (TÜV I think) that showed a Pareto chart with usability being biggest source of AEs or incidents (maybe). This was over five years ago, so maybe the data are different now

When a customer says a product is "Class 3," you want to make sure it is Class 3 in the USA or some other market. Canada has Class 4, EU and Class IIb and Class III, and the classifications change sometimes when you switch markets. You also need to step back and ask the client basic questions: 1. Do you have a design controls procedure? 2. Do you have a design plan? 3. Do you have design inputs approved? 4. Have you had a pre-sub? Many clients we work with for high-risk devices are relying upon our expertise to tell them what the design inputs are and to help them with a pre-sub. Your potential customer may just be too early in the design process to provide them with a quote. Maybe a project with smaller scope to create those documents you need is what should be quoted.

"Scope" has a lot of different meanings depending upon the context. For example, in ISO 19011, scope of an audit is definition 3.5 "extent and boundaries of an audit." In the note, it explains "The audit scope generally includes a description of the physical and virtual-locations, functions, organizational units, activities and processes, as well as the time period covered." Most people think of the standard and clauses being the "scope," but those are actually "audit criteria." When you ask how can be specify the scope of quality or measure it, I think you mean "How can we measure the cost of quality?" or the impact of poor quality. The cost is never limited to the cost of returns and warranty claims. Cost includes administrative costs to record complaints, investigate complaints, implement CAPAs, report MDRs, and execute recalls. Our reputation and future sales is impacted by poor quality too. If you want to measure quality, use your post-market surveillance process to do that. Become and expert in PMS. Don't limit you PMS to customer satisfaction. Learn to use PMS to drive product development and improvement. You also want to use internal metrics to improve you business processes so every system runs smoothly.

@@MedicalDeviceAcademy Thank you so much for the thorough explanation.

Yes, external consultants and auditors are considers external resources under Clause 8.4.

@@MedicalDeviceAcademy thank you

That's certainly a good reason for waiting.

Our pleasure!

You are welcome!