See Ya Later FDA (as in tomorrow)

My time at FDA was over...and now it is back.

Update! I got a call from the FDA at 10:51 AM on February 23, 2025 telling me that I will now be able to come back to the FDA. Apparently lobbying by AdvaMed, the New York Times, and the acting commissioner all appear to have contributed. My computer and internal systems access should be restored by February 24, 2025.

Anyways, back to our original programming in the coming weeks. Currently working on something about Level Nine.

Here is the original story from February 18, 2025 (some minor edits on errors I saw):

On February 15, 2025 at about 6:30 PM I got an email I had been dreading. An acting director in the Department of Health and Human Services had told me that my services were no longer needed because of performance reasons and that since I was probationary it was legal. This is a lie. I have three performance evaluations that demonstrated my proficiency and excellence as a reviewer at the Food and Drug Administration (FDA). I’ve received multiple awards at the FDA including the Honors Award. I’ve even given a keynote talk at the Diabetes Technology Conference in October 2024. I have submitted my appeal about this being a wrongful termination and I’ve been in touch with my NTEU chapter.

While I’m waiting, I am applying to jobs and trying to network and maybe get some consulting gigs going. I’m fully separated from FDA on March 14, 2025. To those of you who have proactively reached out, I really appreciate it, and to those who are thinking about it please just respond to this email, leave a comment, or DM me through the Substack app.

I’m going to take some time to explain what a reviewer like me did in the Center for Devices and Radiological Health (CDRH) and why I think this is one of the most important stories of right now.

The following are all my own opinions/thoughts and do not reflect those of the FDA or CDRH.

Being a Medical Device Reviewer for FDA.

When I thought about being an FDA reviewer, I didn’t really know what to expect. I figured it was a chill job where you sat around, drank coffee, and read a bunch of documents on a computer all day. I was right about the drinking coffee and reading a bunch of documents all day. This was the most intense job I have ever had.

In the Center for Devices and Radiological Health (CDRH) there are just a handful of reviewers and maybe a medical officer or two that hold the line of safety and effectiveness for the American public in very specific disease focused areas. I was part of the diabetes branch, a disease that affects about 11.6% of the United States population or roughly 38.4 million people. The diabetes branch in CDRH deals with both the measurement of glucose and hemoglobin A1c as well as insulin delivery systems such as automated insulin delivery algorithms (artificial pancreas), insulin pumps, and continuous glucose monitors. Any clinical trials associated with these devices would also come to us for review.

The diabetes branch works to ensure that if you are going to be diagnosed with diabetes that the diagnostic instruments are accurate and precise, the devices being used to manage your disease are accurate and precise, and any form of insulin delivery should be safe and effective (you don’t want an unintentional overdose or underdose of insulin… this is how you or your child might die). The patient population spans from 2-year-olds who get a diagnosis of type 1 diabetes all the way to an older adult who may develop type 2 diabetes. This work spans the pre-market authorization side in that we try to ensure any new device is safe and effective, but it also spans the post-market side.

CDRH reviewers work to authorize new devices and also work on monitoring safety issues associated with currently authorized devices or potentially unauthorized devices. The FDA calls this “total product lifecycle” or TPLC and it includes compliance. On the prescription drug side there are usually distinct teams that exclusively work on these issues. In CDRH we are just lucky to get to work on both.

If you are a patient and you complain about the inaccuracy of your device or that it’s not working as expected and you file a complaint to the FDA then ultimately, it’s going to be a reviewer handling your complaint. If a company reports incidents that result in patient death or serious harm (e.g., going to the hospital) known as medical device reports or MDRs then these are monitored by the FDA reviewers too. You can also look them up through FDA’s MAUDE database. For some devices we can look at every single MDR since they might be few and far between. For other high-volume devices there can be millions of MDRs submitted every year. All of this data is public.

Inspections of manufacturing facilities can also come to CDRH reviewers for concurrence or requesting consults on specific actions the agency might take such as a warning letter, untitled letter, or a regulatory meeting. These establishment of inspection reports or EIRs are how the product evaluation experts within CDRH support the Office of Inspections and Investigations.

Any recalls that are initiated by manufacturers will get classified by the CDRH reviewers. The reviewers may even initiate the recall or issue a public safety notice due to the agency’s concerns for public safety. CDRH reviewers will recommend either class I (the most severe), class II, or class III (the least severe) for a recall. Any unauthorized devices that are on the market are something we also look for and try to notify the public is aware that they could be really dangerous.

Sometimes inspectors from the Office of Inspections and Investigations otherwise known as OII (also took a hit from the DOGE) may also bring a CDRH reviewer along for an inspection because our expertise can assist in finding quality system violations (e.g., 21 CFR 820 or ISO 13485) for complex devices.

Finally, as a reviewer in CDRH you may be asked to help draft guidance documents which interpret regulations/laws that help better inform the medical device industry of the FDA’s current thinking regarding specialized situations such as cybersecurity. There is now a law that requires all medical devices to be cybersecure. Here is an example of a recent action taken by CDRH in collaboration with Cybersecurity and Infrastructure Security Agency (CISA):

The U.S. Food and Drug Administration (FDA) is raising awareness among health care providers, health care facilities, patients, and caregivers that cybersecurity vulnerabilities in Contec CMS8000 patient monitors and Epsimed MN-120 patient monitors (which are Contec CMS8000 patient monitors relabeled as MN-120) may put patients at risk after being connected to the internet.

Three cybersecurity vulnerabilities have been identified:

• The patient monitor may be remotely controlled by an unauthorized user or not work as intended.

• The software on the patient monitors includes a backdoor, which may mean that the device or the network to which the device has been connected may have been or could be compromised.

• Once the patient monitor is connected to the internet, it begins gathering patient data, including personally identifiable information (PII) and protected health information (PHI), and exfiltrating (withdrawing) the data outside of the health care delivery environment.

These cybersecurity vulnerabilities can allow unauthorized actors to bypass cybersecurity controls, gaining access to and potentially manipulating the device.

The FDA is not aware of any cybersecurity incidents, injuries, or deaths related to these cybersecurity vulnerabilities at this time.

To the best of my knowledge all of these duties are usually split across multiple teams on the drug side of the FDA (CDER). If this all sounds like an immense amount of work to do as a reviewer—trust your instincts. It’s an insane amount of work to do as a reviewer. But it goes even a level deeper.

Specialization

Every CDRH reviewer is typically a “lead reviewer,” and every CDRH reviewer will also have some sort of review specialty. A lead reviewer is like a project manager for a device submission. If a new insulin pump comes in for a 510k (class II authorization), there might be 10-12 different FDA consulting reviewers working on it across a range of review disciplines from biocompatibility to microfluidics to human factors (that one was mine) to cybersecurity. The lead reviewer is the one who is responsible for putting all of the consulting reviews together into a single coherent memo, typically also taking care of their own review discipline in addition to the labeling, and interacting with the manufacturer/submitter, and working with their branch/division management to ensure that any interim decision (AINN letter, MAJR letter, hold letter, information requests, etc.) and any final decision or public facing document (e.g., the decision summary) are complete, accurate, and thorough.

There is a general expectation within CDRH/FDA that lead reviewers will all at some point be able to do a consulting request and work within a review team with other lead reviewers. I specialized in Human Factors Engineering and led the Office of In-Vitro Diagnostics (Office of Health Technology 7) in that review area and I also did Software and Cybersecurity reviews too. These specialized reviews might span a thousand pages or more of documents in a submission that is over 10,000 pages long with an internal deadline of 30 days or less.

Further, once you specialize in a review area or two you might be working across offices on other devices. For example, while I primarily reviewed diabetes devices and in-vitro diagnostics, I also spent a lot of time working with the Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3) and the Office of Neurological and Physical Medicine Devices (OHT5) where I would provide consulting reviews for the Human Factors Engineering aspects of submissions. My coworkers who were also affected were also considered experts in cybersecurity, software, human factors, sterility and reprocessing, signal processing, and clinical trial design.

Why This Matters

Device reviewers, like I used to be, did a lot of work to ensure that any medical device that the public used was safe and effective. Fewer reviewers mean fewer people looking out for the public health and safety of anyone who would use a medical device. The American public uses medical devices every single day. We use them to measure the temperatures of our children who might have a fever. We use them to measure our blood pressure. We rely on them to keep our loved ones alive in the hospital. The handful of device reviewers who work to keep the public safe just got smaller with the experienced reviewers who were unlawfully removed due to their probationary status. I suspect the ones who are remaining might be looking for the exit next. This means even less.

You, the reader of this newsletter, are probably a user of medical devices. Your Apple Watch which might alert you that you have sleep apnea, or a potential heart attack is a medical device. A single app on your phone can contain multiple medical devices as software. At the end of the day, I think the manufacturers we regulated may have had disagreements with us, but I think they also valued that we were fair. They also paid for the review of their devices with user fees. Removal of CDRH reviewers doesn’t save anyone any money. It only makes our country less safe.

One thing that FDA did for diabetes devices was pioneer the concept of interoperable devices. Automated insulin delivery systems are an ecosystem of interoperable devices which can all be from the same manufacturer (e.g., Medtronic) or multiple manufacturers like how Tidepool, DEKA, and Dexcom all work together despite each device being made by a specific manufacturer.

When I gave the keynote talk at Diabetes Technology Conference in 2024 I ended it with the following (with FDA/office approval):

We [FDA] are advocates for fostering a diverse ecosystem of devices. I’m sure there are devices being developed now with the goal of fulfilling the unmet patient needs of today and the future, but there is also more work to be done to improve equitable access to the incredible devices that are already available.

We hope that the manufacturers in this room will continue to provide pre-market submissions to expand the access and uses of their devices and we want to be collaborative on thinking about this expansion to ensure that these devices can get into the hands of the patients who need them while staying safe and effective.

CDRH’s goal has been to foster a competitive ecosystem of devices that allow patients more choices for devices that meet the needs they have now and any that they might have in the future. FDA doesn’t design devices and doesn’t tell manufacturers what to do but rather tries to paint the lines on the road so that everyone can follow them and get to where they need to go in a safe and effective manner.

If you are a start-up or an established company and you think you might need some help either with polymer chemistry, product development, your go to market strategy or regulatory work (after I’m off administrative leave obviously and fully separated from the FDA), then please respond to this email or reach out to me directly via the comments or a DM.

Thanks for reading. I suspect I’ll be more active here now.

Tony

PS this scene keeps playing in my head now. I originally experienced it as a kid. I’m now experiencing it as a father. Life goes on.