A²I™ Device · United States
FDA market approval evidence
Evidence patterns (8)
Structured patterns in what FDA actually asks for before clearance or approval, each grounded in a real, named device decision.
No valid predicate forces De Novo, not 510(k)
When a device has no legally-marketed predicate to claim substantial equivalence against, a traditional 510(k) isn't available. FDA instead requires a De Novo request, which asks for a full safety/effectiveness case and sets special controls for the whole new device category — a materially higher evidentiary bar than an incremental 510(k).
Example: IDx-DR autonomous diabetic retinopathy detection system · DEN180001
Autonomous AI/software devices need pre-specified accuracy thresholds in an enriched, prospective cohort
For software that makes an autonomous clinical call (no human in the loop), FDA has required a prospective clinical study against sensitivity/specificity thresholds set in advance, with the study cohort enriched to ensure enough positive cases are captured — a materially different bar from a reader-assist tool that keeps a clinician in the loop.
Example: IDx-DR autonomous diabetic retinopathy detection system · DEN180001
Post-market wireless/RF vulnerabilities trigger recalls even after clearance
A device can be cleared on clinical/bench data and still be recalled later when a cybersecurity vulnerability is found in the field — evidence that premarket cyber risk assessment didn't cover the exploit path, not that the clinical case was wrong.
Example: Medtronic MiniMed Paradigm insulin pump (MMT-723) · Z-1594-2020
Missing SBOM / cyber risk management plan now blocks intake, not just review
Since FD&C Act §524B took effect (1 Oct 2023), FDA can Refuse-to-Accept a 'cyber device' submission at intake if it lacks a software bill of materials and cybersecurity risk management plan — a documentation gap that used to surface later as a deficiency letter now stops the submission before substantive review starts.
Example: Cyber device submissions generally (FDA guidance, not a single named device) · FD&C Act §524B guidance
Physical/engineering failure modes missed in bench testing surface as field recalls
Failure modes tied to real-world use conditions (device orientation, gravity, patient handling) can pass premarket bench and engineering validation and still cause a Class II recall once the device is in wide use — indicating the original test protocol didn't stress the actual use environment.
Example: Medtronic MiniMed 720G insulin pump · Z-1745-2026
PMA approval conditions are ongoing, not a one-time gate
For Class III (PMA) devices, approval frequently comes with a mandated post-approval study protocol and locked manufacturing/inspection methods. Every later change to the device or its manufacturing — even a change to an inspection method — requires its own supplement and its own supporting evidence package.
Example: Boston Scientific WATCHMAN / WATCHMAN FLX left atrial appendage closure device · P130013 (see supplements S004, S070)
Sensor-life / minor-change extensions can use Special 510(k), not a new clinical trial
When a modification to an already-cleared device doesn't raise new questions of safety or effectiveness, FDA allows the Special 510(k) pathway — comparison to the sponsor's own predecessor device rather than a fresh clinical trial. This is the low-evidentiary-bar end of the spectrum, useful context for why not every device iteration needs new trial data.
Example: Dexcom G7 Continuous Glucose Monitoring System · K240902
Repeated malfunction reports across a product line indicate original substantial-equivalence testing didn't stress real failure modes
When MAUDE (adverse event) reports show the same failure type recurring across many units of a cleared device — not an isolated defect — it signals the original 510(k) testing protocol didn't adequately probe that failure mode before clearance.
Example: Insulin pump product line (device.generic_name: insulin pump) · MAUDE query, product code LZG
Verified individual FDA decisions (8)
Sourced from the openFDA API (510(k), PMA, and enforcement/recall endpoints) and FDA-hosted De Novo decision summaries. Every entry links to the query or document used to verify it.
Dexcom G7 / G7 15 Day Continuous Glucose Monitoring System
published 3 February 2026
Cleared as substantially equivalent to the prior Dexcom G7 predicate (traditional 510(k)).
Dexcom G7 Continuous Glucose Monitoring System
published 23 April 2024
Cleared via the Special 510(k) pathway as substantially equivalent to predicate CGM devices.
IDx-DR autonomous AI diabetic retinopathy detection system
published 11 April 2018
Authorized via De Novo classification as the first autonomous AI diagnostic device, creating a new Class II category.
NightWare (Apple Watch/iPhone-based digital therapeutic for PTSD-related sleep disturbance)
published 6 November 2020
Authorized via De Novo, establishing a new device classification since no predicate existed for this mechanism/indication.
Boston Scientific WATCHMAN Left Atrial Appendage Closure Device
published 18 March 2016
PMA supplement approving the mandated post-approval study protocol, confirmed as a condition of the original approval.
Boston Scientific WATCHMAN FLX / FLX Pro Left Atrial Appendage Closure Device
published 23 September 2024
PMA supplement approving a change from manual to automated inspection for detecting bent device-frame struts.
Medtronic MiniMed Paradigm Insulin Pump (MMT-723)
published 26 March 2020 (classified); initiated 27 June 2019
Class II recall for a wireless RF vulnerability allowing unauthorized remote alteration of insulin delivery.
Medtronic MiniMed 720G Insulin Pump
published 2 April 2026 (classified); initiated 13 February 2026
Class II recall for over-/under-delivery of insulin caused by gravitational/hydrostatic pressure effects during real-world handling.