5440

My son was just arrested for using this in his hacking club at high school. Be careful if you have kids with one. According to witnesses in the room, he was showing it to kids in his hacking club and they all thought it was just turning off Apple phones in the classrooom. Apparently, it turned off phones including several teachers in adjoining classrooms. Anyways. The police came to the school and arrested him and are threatening him/us with federal crimes. They also executed a search warrant in our house and took all electronics. Its been a little traumatising to say the least.

For those of you in FDA regulated devices, my clients started receiving FDA NSE letters for not performing fuzz testing. For example, "Though you have provided penetration testing, it does not appear that you have addressed the other items identified such as static and dynamic code analysis, malformed input (fuzz) testing, or vulnerability scanning. This testing is necessary to assess the effectiveness of the cybersecurity controls implemented and to determine whether the residual risk of your device is acceptable."

Man this applies to me. I got an bioengineering degree and had to go to the US to find work. I started at $30K in the US and now I'm up to over $350K/yr. Would love to come back to Canada but the horrible expereince of applying for over 100 jobs and no interviews was disheartening.

I'm a regulatory consultant and I am currently submitting at least 5-10 510ks/DeNovos per week to FDA for AI/ML devices for a variety of companies. I can't imagine the actual throughput from companies as I am just one person out of many consultants out there. 95% of the software devices I edit and submit are hosting their databases on AWS. Essentially they transer the DICOM images to AWS and then run their algorithms against the data and then present the indications to the physcian. These run the range of CT/MRI/Ultrasound/pathology slides/genomic sequencing. Like I said, most of the databases are on AWS. A few are on Azure and a few european companies are on Orange.

I'm currently working on a required CDC (Center for Disease Control) reporting function for a COVID test. For a second I thought this article was going to be extremely helpful.

I audit a lot of these Fentanyl API (Active Pharma Ingredient) factories in China. Its noticeable to me when I go through the warehouses as to how much product is going to Mexico. Other segments go to India for legal fill finishing prior to North America, while other small shipments are going to compounding facilities across the US. I always thought FDA might want to relay this information to homeland security, because its pretty easy for FDA inspectors to sneakily gather information during site inspections. At quite number of sites I often run into a mix of legal and nefarious activity at these massive API sites

I think those are generally good questions but the majority of submissions that FDA CDRH are reviewing are for imaging of ultrasound, MRI, XRAY etc, with a sprinkling of audio AI and maybe some individualized vaccines predictions at CDER.

These questions are generally addressed during the pre-sub for each FDA submission but I agree that the demographic information could be pretty infinite. I'm working on at least 5 of these AI submissions per week.

For example, lets say you have an AI submission for identifying cardiac ultrasound images. FDA will ask for very specific demographic information in the training and performance tests, as well as comorbidities (such as hypertension) for each training image. In addition, they will want at least three physicians to annotate the images. The training dataset is likely to contain at least 100-200K images.

That FDA review division does require that information and testing to be supplied with infusion pump testing. In fact, they are one of the few that routinely asks for substantial testing in repeated deficiency requests.

The new draft literally doesn't change anything. It just defines some of the things that FDA has been already asking for in the past 7 years for every device submission.

Just my opinion as someone who has worked on many infusion pumps; that FDA review division is the best at FDA. They probably ask more cybersecurity questions than any other group I've encountered.

I review a minimum of 5x - 510ks a week.