Nedklassefisering av en slik kategori har blitt gjort fĂžr. (se Regulations.gov Uroviu)
At instrumenter blir brukt innenfor riktigsikkerhet blir fanget opp med 510(k) sĂžknad prosessen og Ă„pner opp for flere tilbydere.
This reclassification from Class III to Class II is in line with recent reclassifications from Class III to Class II for radiological computer-assisted diagnostic software in 2020, the positive airway pressure delivery system in 2018, and certain Hepatitis C diagnostic tests in 2021.
Such reclassification of blue light systems from Class III to Class II is supported by its clinical use which has provided sufficient data to show that the blue light system meets the reasonable assurance of safety defined in 21 CFR 860.7(d)(1) and the reasonable assurance of effectiveness as defined in 21 CFR 860.7(e)(1). The blue light system has a long history in the clinic with an excellent benefit-risk profile that fits a Class II designation. This is substantiated in the fact that areview of the FDAâs Manufacturer and User Facility Device (MAUDE) database, from the period
1 January 2010 to 31 January 2023, found only one (1) report with use of the Storz ICG light in 2019, and no reports associated with use of blue light cystoscopy or Cysview (hexaminolevulinate HCL) .
As a Class II device, the medical device industry will be able to provide 510(k) submissions for additional and iterative devices with reduced, but still appropriate, documentation as to performance against standards. Since device companies are often resource constrained, new devices and technologies that can be reviewed as a 510(k) are more easily funded and developed than those requiring a PMA. This then will result in more access to this technology by physicians and patients since the medical device industry, especially start-up companies, with the development of complimentary systems.
Thank you for the opportunity to comment on this important patient health issue. Regards,
Bruce OuYang, PhD CEO and Head of R&D