Yes, they can be reviewed in parallel. However, I recommend waiting until you receive the Q-sub number assignment for one of the two before submitting the second. This will allow you to reference the second submission as a supplement (i.e., S001) to the first. For one of our clients we submitted the STeP first and submitted the pre-sub the following day once we received the letter from the FDA providing the assigned Q-sub number for the STeP.

You're welcome!

Glad it was helpful!

Lately we have been copying and pasting content of records into our reports using screen captures. This saves a lot of typing and speeds up our reports. Some things take longer to conduct remotely, but not everything.

Most companies will choose remote audits to reduce travel costs, but if you are conducting verification of effectiveness for a supplier corrective action--that would only require a short duration that is not worth traveling. Another example is software developers. If 50%+ of the developers work from home, what does it matter if you go to their office or audit them remotely.

To try and classify the device and determine the pathway yourself, you start with the indications for use. If you find another exercise device that has the same indications (or you find a regulation for exercise devices that has the same intended use), that's a great sign. Step two is to look at the technological characteristics. If those introduce new risks, that might be a problem. This may be true if the technology is totally new. The more expensive alternative is to submit a 513(g) to the FDA.

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You're very welcome. I hope it helps.

That's great that you are finding useful content. Don't hesitate to suggest new ideas and to share with your colleagues.

The companies can't share the role of specification developer and 510(k) owner, but both companies can distribute the product. The 510(k) owner will be identified on their label as "Manufactured by" while the sister company will label the product with "Manufactured for" or "Distributed by." They can also have two different brand names or the same brand name. If both companies are in the USA, the sister company does not even need to register, because they are considered a distributor.

@@MedicalDeviceAcademy thanks bob for your clarification provided.

Great technical question and sharp eyes! That is for letters of authorization when the submitter is referring to a device master file (MAF#) that includes confidential information--typically owned by their contract manufacturer or component supplier.

That's a good suggestion. We also have a section we added to our report for follow-up items. We usually specify when the next internal audit is scheduled and we provide a link for requesting a quote from our director of sales.

Clinical harm is referring to harm to patients and users when the device is used as intended. It doesn't include abnormal use, it doesn't include damage to other equipment, and it doesn't include shipping clerks picking up the box it is shipped in. However, user groups can include sterile processing and other personnel in an operating room that might be exposed to radiation, electrical surges, or heavy falling equipment.

Yes, we offer US Agent services. You can visit our contact us page to request a copy of our US Agent agreement: medicaldeviceacademy.com/contact-us/ Or visit our website specific to those services: fda-us-agent.com/

RUO products are at the lowest level of regulation and are not subject to the same regulatory requirements as medical devices. They do not require the same quality controls or documentation as medical devices. Labeling is regulated to ensure that users can clearly differentiate them from devices by labeling the products with "Research Use Only" and "RUO." This is addressed in the FDA guidance on IVDs labeled as RUO or IDE: www.fda.gov/regulatory-information/search-fda-guidance-documents/distribution-in-vitro-diagnostic-products-labeled-research-use-only-or-investigational-use-only. If you are using the RUO products to develop instructions for use or to validate an assay, then you will want to use your quality system to create prospective protocols with acceptance criteria and keep records for submission. These articles may be used for human factors testing too. If the products are used on animals, then IACUC committee approval is required. If the products are used on humans, then they must be used under IRB approval and/or FDA approval with IDE labeling instead of RUO labeling. If your company is ISO 9001 certified, you would still follow your quality system procedures and have complaint handling. If you are ISO 13485 certified, you could exempt the RUO products from your quality system. I was not able to find any specific QMS or complaint handling requirement for RUO products.

In general, I try to use risk controls to develop products that are better and safer than competitor products as a way to differentiate the product. If I can't do that, the project is not very interesting to me. That's why I love working on breakthrough designation products and STeP projects. The complete phrase in the EU regulations is "As far as possible when considering the state of the art." Therefore, you have to perform PMS surveys to determine what is state of the art. Then you know what "AFAP" is. I also focus a lot more on elimination of risks by design, while most people (including the FDA) rely too heavily on warnings.

That's a good point. I forgot to include references to the clauses. Sometimes it overwhelms people when I include the clauses, but that is a good observation. I'll try to make sure I include that in future turtle diagrams. For design controls, here's the key references: 1. Description of the process = 7.3 2. Inputs = 7.1 - planning of product realization & 8.2.1 - feedback should both be considered inputs; you could also consider the planning in 7.3.2 as an input to design; 7.3.3 is the obvious design input given the title 3. Outputs = 7.3.4 is an output; the records (4.2.5) that are included in almost every clause of design, plus 7.3.10 for the files or even 4.2.3 for the medical device files 4. With What = 6.3 - infrastructure, 7.6 - calibration, 4.1.6 - software tool validation 5. Who = 6.2 training/HR 6. How done = 4.2.3 control of records, 7.3.1 - procedure for design controls; you could also include procedures for risk management (7.1), usability (7.3.3), and other standards 7. Metrics = 8.2.3 monitoring and measurement of processes

@@MedicalDeviceAcademy Thanks. I have the standard and I've been involved in many medical device audits. I see software types consumed with some legalistic level of traceability. My point is it is NEVER audited for, they may ask for the author of the doc but are disinterested in whatever authorization you have to 'sign' the doc unless there seems to be a training issue.

Usually if the subject device is claiming a subset of the intended patient population, then only the labeling needs to state that limitation and the justification is simple in the SE comparison--the subject device excludes the pediatric population and this is stated in the warnings/precautions or even in the indications for use. In the reverse situation (i.e., adding pediatric patients), then the FDA usually wants HF testing and clinical testing--in addition to different labeling and instructions. You may also need to identify a reference device, a secondary predicate, or even identify a different product code unique to pediatrics.

There would be a small benefit in the USA for having MDSAP, because you would be exempt from routine audits. I'm not sure that's worth an annual cost of $30-40K for MDSAP. In the other countries it would not be permitted because you are not pursuing a license or registration for a device.

You can request that the certification body perform an extension to scope at any time. They can do it as a separate audit, as part of one of the annual surveillance audits, or at the 3-year recertification audit. All three work. Only Canada requires it. Once you register in Brazil, you will be required to add Brazil to your MDSAP. If you don't notify your certification body in advance it is failure to notify them of a significant change. That would be a nonconformity and maybe even a major. However, it can be added at any time--not just during a surveillance or 3-year recert. The audit costs are based on hours, and adding a new country to the scope will add time and $.

The worst-case is 60 calendar days, but the new on-line submission through the FDA CCP should help to expedite that for US companies. Here's a link: medicaldeviceacademy.com/small-business-qualification/ The link for the CCP is at the beginning of the article.

@@MedicalDeviceAcademy Thank you for your response!

We had a client with 9, and my personal record on a project was 5. In theory there is no limit, but the FDA will eventually refuse the request.

Unfortunately, we only help small companies with a single DFUF account. You will need to ask the registration help desk and you may need their help to complete the process.

Penetration testing must be done by people who are independent of the software development team that developed the software you are testing. If you have a small team, independence of internal people is nearly impossible. However, it is possible to have a larger company with independent teams that specialize in penetration testing. You could also have two separate teams that perform penetration testing on the other team's work. Regardless of which approach you use, you must document the qualifications and the independence--as well as the efforts that were taken to penetrate the software.

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Thank you for watching.

Thank you for participating and the comments.

The challenge with "accessories" is that the regulations are based on what the manufacturer intends for the use of the device and what the device is labeled for--not what users might use the device for "off-label." If the manufacturer of the adapter is intended to be used independently of other devices, then it is a medical device and not an accessory. However, the word "adapter" suggests that the device cannot be used alone and is intended by the manufacturer to be used with two other devices as an adapter (e.g., connection between tube and mouthpiece). Therefore, it cannot be used alone, and it was not intended to be used alone. However, the regulations do not make a distinction between an accessory and an accessory to an accessory. It is an accessory or it is a medical device. In this case, both the EU and US regulators would consider this an accessory device. The adapter could also be integrated into the tube, or the adapter could be integrated into a mask, and it would still be an accessory. The regulatory pathway would depend entirely on the indications for use. An adapter that is intended for use with a ventilator might be regulated differently from an adapter for an oxygen mask. However, the part might be identical in design for both applications. We see this a lot in the case of electrical cables. Unfortunately, in these borderline classifications, the regulator is not always consistent. We have seen bridge software used as an accessory between two other accessory software devices treated as an accessory device by one member state and treated as a non-device by another member state. In these cases, the competent authorities are supposed to yield to the recommendations for the MDCG. In the case of the FDA, the determination is typically made by submitting a 513(g).

Blood and blood components are not something that you can remove once you infuse them into the body. Whatever chemicals were extracted or leached into the blood and blood components will remain in the blood once you infuse it--even though the IV bag may only be connected to the patient for minutes. Therefore, the testing for demonstrating biocompatibility should be evaluated for the long-term endpoints instead of the limited duration endpoints. It is also recommended to review the biological evaluation plan with the regulator in advance, because the storage environment is unique and may result in a very different extraction of chemicals from the bag than room temperature storage. I would expect regulators to look for evidence of how the risk of cryopreservation has been addressed--in addition to the endpoints listed in ISO 10993-1.

Each location pays once--regardless of the number of roles. Therefore, if you are manufacturer, specification developer, and complaint establishment, it is still only one fee per location.

If you don't register, you can't ship product into the USA if it is contract manufactured outside the USA or if your company is outside the USA. If your company manufactures in the USA, the FDA has the ability to shutdown your facility and take you to court.

You're very welcome, my friend. Would you like to be a guest for one of our live-streaming sessions?

@@MedicalDeviceAcademy, I would, and right now I'm trying to figure out which of your courses to order first. There is the dhf course, end of the design controls course. I have something coming up in a month or two where someone would like me to get their DHS taken care of.

Our pleasure! This is a demo that I have been doing since 2010, but please watch our live-streaming next week. I have a special presentation with my new Remarkable Paper Pro that where I will be using the turtle diagram to do a process audit of sterile device manufacturing. I will also be showing people how to do a gap analysis of procedures on the tablet.

I love it! Here's the link for next week's live-streaming video: streamyard.com/watch/9VKTEMM8yERg So far, I found that the Paper Pro is disappointing with regard to the color in person. But the color is vibrant and exactly what I wanted when I share my Paper Pro through the Desktop App. Therefore, if you are using it as part of a multi-media display took it is phenomenal. If you are using if for editing a PDF it will surprise and amaze...but it is not my first choice for one-on-one drawing in color. Black & White is great one-on-one, but not the color. I'll have to create a short to demonstrate it properly. I'll share the link to the short as a reply to this tomorrow.

@@MedicalDeviceAcademy Thank you!!

www.fda.gov/media/71966/download - Here's a link to an FDA guidance.

Good luck. You know who to call if you need help.

Glad to hear it!

Yes, but the information you learn from the searches can help prevent future problems.

Thank you for watching.

Glad you think so! Thank you for watching.

I'm not 100% sure what kind of example you are looking for. In the video, Matthew did not mention the word "tool" and compliance was mentioned 3 times (6:55-7:18). Matthew indicated that compliance with IEC 62304 is demonstrated by inspection of the documentation required by IEC 62304. Specifically, there are 10 documents that the FDA asks companies to attach in a 510(k) and all of those documents are required by IEC 62304 except for the software description document. Another example of how this is done is when NRTL labs request that companies fill out an IEC 62304 checklist to demonstrate where all of the software documentation requirements can be found when you are submitting a device with software to the lab for electrical safety (i.e., IEC 60601-1). In both cases, the inspector is using a checklist that lists each document requirement that is a required output of IEC 62304. Usually, a keyword search can help you find the required documents. For example "and documented" appears 22 times in IEC 62304. Only some of these are required documentation, but that gives you a good list of what will be required (I started a list by starting at the end of the standard...) Clause 5.3.6 Clause 5.4.4 Clause 5.5.5 Clause 5.6.3 Clause 6.2.2 Clause 7.2.1

It just wish I had cookies at the the time as a visual aid...poor planning.