Delt tidligere :
Takker, et raskt søk via AI, tyder på at han ikke har noe relasjon til KZ, han har vist kommentert på mange saker hos FDA.
Kommentar merket (#) deler jeg Steven sin interesse for, ikke lenge siden begrunnelsen for avslag kom, hva har endret seg siden?
Kommentaren i sin helhet :
This proposed order reclassifies diagnostic endoscopic light source systems (product code OAY) from class III to class II under a new regulation, 21 CFR 876.1560, renamed “Cystoscopic system intended as an aid for detection of bladder cancer.” Section V and Table 1 tie each of the six identified risks to health to a specific special control – false positive/negative results to clinical data and labeling, device failure to non-clinical testing and software hazard analysis, infection risk to sterilization validation, and so on. That risk-by-risk mapping is the right structure for a reclassification: it lets a reader trace each proposed 876.1560(b) requirement back to a documented hazard rather than a generic checklist.
(#) That same traceability does not fully carry through to two places in the record. The first is procedural. In October 2022, the PDD System’s manufacturer petitioned FDA to reclassify product code OAY from class III to class II (Docket FDA-2022-P-2644), including a February 2024 draft special control guidance submission. On March 27, 2026, FDA denied that petition because it “did not agree that the information provided and the special controls proposed by the petitioner supported reclassification.” Less than five months later, FDA is proposing the identical reclassification on its own initiative. A change in outcome is not itself irregular – but the notice does not say what changed in the evidence, or how the special controls proposed here differ from the ones the petitioner offered and FDA found insufficient. Stating that basis in the final order would let the record show what actually moved the outcome, rather than leaving readers to infer it.(#)
The second gap sits inside the special controls themselves. FDA’s MAUDE review found 11 unique MDRs for product code OAY as of April 30, 2026, and reports that “most of the adverse events were related to thermal injury from contact with the light cable.” The corresponding special control, proposed 876.1560(b)(3), requires performance testing that demonstrates “electrical, mechanical, thermal, and optical safety” generally, without a quantified thermal threshold – a maximum light-cable surface temperature or permissible contact duration – tied to that specific, dominant failure mode. Given that this one hazard accounts for most of the adverse event history FDA relied on to support reclassification, anchoring the thermal-safety testing to a measurable limit, referencing an applicable electrical-safety standard, would close the loop between the documented harm and an enforceable engineering requirement rather than leaving “thermal safety” for each 510(k) submitter to define.
A third gap sits in the same MDR data. Two of the 11 reports found that “the blue light mode stopped working after the first use” – a first-use reliability failure on a device with reusable, reprocessable components. Proposed 876.1560(b)(2) requires testing showing the device “performs as intended under anticipated conditions of use,” and (b)(5) adds software verification and hazard analysis, but neither is framed as a durability or repeated-use test, and a first-use light-source failure is not obviously a software defect. Clarifying that (b)(2) covers functional reliability across the device’s intended use cycle, not only a single-use bench demonstration, would tie the control back to that specific failure mode.
A related question follows from where the underlying data comes from. Every clinical and non-clinical performance parameter cited in Sections IV through VI – illumination spectrum and intensity, filter specifications, excitation power and density, optical performance – derives from a single approved device-drug combination, the PDD System with CYSVIEW, the only product ever cleared under this product code. The reclassification and the resulting 510(k) pathway will apply broadly to any future product-code-OAY device using any compatible optical imaging agent. Stating the (b)(2) performance parameters as device-agnostic, quantifiable acceptance criteria, rather than criteria benchmarked only against the incumbent’s own specifications, would let a new entrant with a different light source or imaging agent know what standard it is actually held to.
None of this counsels against reclassification; the risk-to-control mapping in Table 1 shows the underlying framework is sound. These points ask FDA to extend that same specificity to the procedural basis for the reversal, the thermal-injury and reliability controls, and the device-agnostic framing of the technical parameters before the order is finalized.
kan ha noe rett i sine konspirasjonsteorier.
