The FDA published three final orders on July 24 creating permanent regulatory categories for a test that estimates how fast chronic kidney disease will progress, a prescription app that delivers behavioral therapy for diabetes, and at-home COVID tests.
Each one reads like news. None of it happened this month.
All three orders codify classifications the agency already granted in mid 2023. The kidney test category became applicable on June 29, 2023, the COVID test category on June 6, 2023, and the diabetes app category on July 7, 2023. What changed last week is that the classifications now appear in the Code of Federal Regulations, at sections 862.1223, 866.3984, and 880.5735.
That distinction matters because nothing became newly available, newly covered by insurance, or newly recommended. The value in these documents is in the limitations FDA wrote into each category, which are more restrictive than the product names suggest.
What Each Category Actually Covers
The kidney category came from Renalytix AI’s KidneyIntelX.dkd, submitted in August 2020. FDA defines the generic type as an in vitro diagnostic that measures one or more analytes from human samples as an aid in assessing the risk of chronic kidney disease progression.
Then it draws hard boundaries. The regulation states the device is “not intended for diagnosis of any disease,” and separately that it is not intended for serial monitoring of kidney disease progression or for monitoring the effect of any therapeutic product. Labeling must carry those limits.
That is a narrower tool than most patients would assume. Standard kidney measures, estimated glomerular filtration rate and urine albumin, are used both to stage disease and to track it over time. A prognostic test in this category answers a different question once: how likely is this to get worse? It cannot tell a patient whether they are improving or whether a medication is working, and FDA explicitly forbids marketing it for that.
The diabetes category came from Better Therapeutics’ BT-001, submitted in September 2022. FDA defines it as a prescription software device providing digital behavioral therapy to aid diabetes management, and the agency’s own language is strikingly modest: the device is “intended to provide limited secondary benefit” to patients, and is “not intended to replace any primary treatment, such as diet/lifestyle changes or medication.“
Required labeling goes further. It must state the device is not for standalone therapy, not a substitute for prescribed therapy or medication, should not be used by people with unstable psychiatric disorders, and is not intended to treat any psychiatric disorder or symptoms.
Notably, among the risks FDA identified for this category is that treatment could result in anxiety, depressed mood, depression, stress, or suicidal ideation. That is an unusual hazard list for a diabetes product, and it explains the psychiatric exclusions.
The COVID category came from Cue Health’s Cue COVID-19 Molecular Test, submitted in May 2022, and covers at-home tests used by lay users without a health care provider.
The COVID Rule Is Where the Consumer Detail Sits
The at-home test regulation reads like a list of everything that goes wrong when people test themselves, converted into mandatory labeling.
Manufacturers must state that “positive results do not rule out co-infection with other respiratory pathogens,” and that a negative result does not exclude infection with something else. They must warn that the test is not a substitute for consulting a clinician and should not be used to determine treatment without provider supervision.
Two requirements deserve attention from anyone who keeps tests in a drawer. Labels must state that expired tests can produce incorrect results, and that accuracy depends on proper storage, which is a real issue for kits stored in hot cars or unheated garages. Labels must also state that false positives become more likely when community prevalence is low.
The variant requirement is the most interesting. Labeling must name the strain or variant that was dominant when performance was established, warn that accuracy may change as new viruses emerge, and advise that lab-based PCR testing should be considered when a new variant is suspected. Manufacturers must continuously monitor for genetic mutations and, if FDA asks, submit evaluations within 48 hours.
The rule also builds in emergency machinery. If a public health emergency involving SARS-CoV-2 is declared, manufacturers have 30 days from FDA notification to test their device against characterized samples and 60 days to publish results, continuing for three years.
Performance has a floor: clinical studies must show the lower bound of the two-sided 95% confidence interval for positive percent agreement exceeding 70%. That is a meaningful number for readers to hold, because it means a test in this category can legitimately miss a substantial share of infections.
What This Changes for Patients
Almost nothing, immediately, and that is the honest answer.
Class II with special controls means a device type avoids the automatic class III designation that would otherwise require premarket approval. The practical effect is on manufacturers rather than patients: once FDA classifies a device type this way, later companies can use the less burdensome 510(k) pathway instead of filing their own De Novo request. FDA said each action would “enhance patients’ access to beneficial innovation, in part by reducing regulatory burdens.“
Over time, that can mean more competitors and lower prices in a category. It is not a promise, and FDA has not exempted any of these three types from 510(k) review, so individual products still need their own authorization.
For patients, the useful takeaways are about expectations. Anyone offered a kidney progression test should understand it estimates risk once and is not a monitoring tool, and should ask what the result would change about their care. Anyone prescribed a diabetes therapy app should know FDA classified it as providing limited secondary benefit alongside, not instead of, medication and lifestyle change. Anyone using at-home COVID tests should check expiration dates, consider how the kit was stored, and treat a negative result during a new variant wave as less reliable than a PCR.
Nobody should start, stop, or change a medication, or skip a monitoring test, based on any of this.
One thing readers may notice: two of the three companies whose submissions created these categories have had well-publicized business difficulties since 2023, which is worth verifying before publication and which illustrates that a regulatory category outlasts the product that established it.
What Happens Next
Comments are closed on all three orders, which took effect on publication. The categories now function as predicates, so the next observable developments would be 510(k) clearances of similar devices, and any future FDA decision to exempt a type from premarket notification.
The bottom line: FDA codified three device categories on July 24, all of which were actually classified in 2023, covering a kidney progression test, a prescription diabetes therapy app, and at-home COVID tests. Patients considering any of the three should note the limits FDA wrote into each. The reasonable action is to ask what a given test or app would change about care. The central uncertainty is whether these categories attract competing products.
Frequently Asked Questions
What did FDA actually do? It published final orders adding three device categories to the Code of Federal Regulations. The underlying classifications were granted in June and July 2023.
Does this mean new tests are available? No. The devices that created these categories have been legally marketable since 2023. No new product launched.
What does the kidney test do? It estimates the risk that chronic kidney disease will progress. FDA states it is not for diagnosis, not for serial monitoring, and not for tracking whether a treatment is working.
Can a diabetes app replace my medication? No. FDA classified this device type as providing limited secondary benefit and requires labeling stating it is not a substitute for prescribed therapy or medication.
Who should not use a diabetes therapy app? FDA requires labeling stating it should not be used by people with unstable psychiatric disorders and is not intended to treat psychiatric conditions.
What changed for at-home COVID tests? Nothing you buy changed. The codified rule requires labeling about expiration, storage, variant limitations, co-infection, and when to seek PCR testing.
How accurate must an at-home COVID test be? Clinical studies must show the lower bound of the two-sided 95% confidence interval for positive percent agreement above 70%, meaning some infections will be missed.
Does class II mean FDA approved it? Class II devices generally require premarket notification, a 510(k), rather than premarket approval. FDA has not exempted any of these three types from that requirement.
