This document reflects the current review guidance for the Phacofragmentation System device. It is based on 1) current scientific knowledge, 2) clinical experience, 3) previous submissions by manufacturers to the Food and Drug Administration (FDA), and 4) the Food, Drug and Cosmetic Act, as amended, the Safe Medical Devices Act of 1990 as amended, and FDA regulations in the Code of Federal Regulations (CFR). Following advances in science and medicine, and any new amendments by the Congress to the device acts, these review criteria will be reevaluated and revised as necessary.
This document is an adjunct to the CFR and other FDA Guidance documents for the preparation and review of 510(k) submissions. It does not supersede those publications, but provides additional clarification on what is necessary before the FDA can clear a device for marketing. The submission must provide evidence (21 CFR 807.92 (a)(3)) that the device is SUBSTANTIALLY EQUIVALENT to a device legally marketed in the United States. In some cases, the performance of the device can be established by comparison of the device to a standardized reference method, in addition to the comparison to a legally marketed device.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.