Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 886</CFR> <DEPDOC>[Docket No. FDA-2018-N-3074]</DEPDOC> <SUBJECT>Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Final amendment; final order. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order reclassifying the ultrasound cyclodestructive device, a postamendments class III device (product code LZR), into class II (special controls), subject to premarket notification. FDA is also establishing special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is finalizing this reclassification on its own initiative based on valid scientific evidence. For this class II device, instead of a premarket approval application, manufacturers may submit a premarket notification, <E T="03">i.e.,</E> a 510(k) submission, and obtain FDA clearance of the device before marketing it. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> This order is effective June 20, 2024. </DATES> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Claudine Krawczyk, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1238, Silver Spring, MD 20993, 301-796-6860, <E T="03">claudine.krawczyk@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background—Regulatory Authorities</HD> The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls and general controls), and class III (premarket approval and general controls). Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices) are automatically classified by section 513(f)(1) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval, unless and until (1) FDA reclassifies the device into class I or class II; or (2) FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to previously marketed devices by means of the procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and our implementing regulations (part 807, subpart E (21 CFR part 807, subpart E)). A postamendments device that has been initially classified into class III under section 513(f)(1) of the FD&C Act may be reclassified into class I or class II under section 513(f)(3) of the FD&C Act (21 U.S.C. 360c(f)(3)). Section 513(f)(3) provides that FDA, acting by administrative order, can reclassify the device into class I or class II on its own initiative, or in response to a petition from the manufacturer or importer of the device. To change the classification of the device, the new class must have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. Reevaluation of the data previously before the Agency is an appropriate basis for subsequent action where the reevaluation is made in light of changes in “medical science” ( <E T="03">Upjohn</E> v. <E T="03">Finch,</E> 422 F.2d 944, 951 (6th Cir. 1970); <E T="03">Ethicon, Inc.</E> v. <E T="03">FDA,</E> 762 F. Supp. 382, 388-391 (D.D.C. 1991)). Whether data before the Agency are old or new, the data to support reclassification under section 513(f)(3) must be “valid scientific evidence,” as defined in section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2). (See, <E T="03">e.g., General Medical Co.</E> v. <E T="03">FDA,</E> 770 F.2d 214 (D.C. Cir. 1985)). FDA relies upon “valid scientific evidence” in the classification process to determine the level of regulation for devices. To be considered in the reclassification process, the “valid scientific evidence” upon which the Agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information, <E T="03">e.g.,</E> the contents of a pending premarket approval application (PMA) (see section 520(c) of the FD&C Act (21 U.S.C. 360j(c)). Section 520(h)(4) of the FD&C Act provides that FDA may use, for reclassification of a device, certain information in a PMA 6 years after the application has been approved. This includes information from clinical and preclinical tests or studies that demonstrate the safety and effectiveness of the device, but it does not include the descriptions of methods of manufacture and product composition and other trade secrets. Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the requirements under section 510(k) of the FD&C Act if FDA determines that a 510(k) is not necessary to provide reasonable assurance of the safety and effectiveness of the device type. On September 25, 2018, FDA published a proposed order in the <E T="04">Federal Register</E> to reclassify the ultrasound cyclodestructive device (product code LZR) (83 FR 48403, the “proposed order”). The period for public comment on the proposed order closed on November 26, 2018. FDA received and has considered comments on the proposed order, as discussed in Section II of this document. <HD SOURCE="HD1">II. Comments on the Proposed Order and FDA Responses</HD> <HD SOURCE="HD2">A. Introduction</HD> FDA received fewer than 10 public comments on the proposed order. These comments came from individual and anonymous commenters. The majority of the comments supported the proposed reclassification of ultrasound cyclodestructive devices. We describe and respond to the comments in section II.B. The order of the comments and our response to them is purely for organizational purposes and does not signify the comment's value or importance nor the order in which comments were received. Certain comments are grouped together under a single number because the subject matter is similar. <HD SOURCE="HD2">B. Description of Comments and FDA Response</HD> (Comment 1) The majority of commenters supported the proposed reclassification of ultrasound cyclodestructive devices. One commenter stated that decreasing the regulatory burden (through reclassification of the device from class III into class II) for ultrasound cyclodestructive devices will hopefully allow increased access of the devices for patients. The commenter further stated that having stricter manufacturing and regulatory controls during the initial years of device use (as a class III device) and then decreasing the controls should not result in an increase of known medical incidents. Another commenter stated that there is sufficient information to establish special controls which can provide a reasonable assurance of safety and effectiveness. (Response 1) FDA agrees with the comments. Based on the available information (including valid scientific evidence), as discussed in the proposed order, and consideration of the comments received on the proposed order, FDA has determined that reclassification of ultrasound cyclodestructive devices into class II is appropriate because there is sufficient information to establish special controls for the device that, together with general controls, will provide for reasonable assurance of safety and effectiveness. The Agency believes that reclassification of ultrasound cyclodestructive devices under this final order will reduce the regulatory burden on manufacturers, while still providing reasonable assurance of safety and effectiveness. Specifically, reclassifying this type of device from class III into class II will reduce regulatory burdens on industry because instead of submission of a PMA, manufacturers may submit a less burdensome premarket notification ( <E T="03">i.e.,</E> a 510(k) submission) and obtain FDA clearance of the device before marketing it. Additionally, FDA agrees that there is sufficient information to establish special controls and that the special controls required in this final order, along with general controls, provide a reasonable assurance of safety and effectiveness for these devices for their intended use. FDA has identified the probable risks to health in section V of the proposed order, and the Agency has determined, in finalizing the proposed order after considering the comments received, that the special controls in this final order will mitigate such risks to health. (Comment 2) A commenter stated that ultrasound cyclodestructive devices should be reclassified into class II, similarly to devices indicated for use in conventional refractory glaucoma treatment modalities ( <E T="03">e.g.,</E> implantable aqueous shunts and valves, cyclocryotherapy, laser transcleral cyclophotocoagulation), all of which are regulated as class II devices subject to 510(k) requirements. The commenter stated that it also concurred with the definition of refractory glaucoma described in the proposed order and claimed that the definition is consistent with current medical practice for the management of the disease and with other device treatment modalities cleared by FDA ( <E T="03">e.g.,</E> implantable aqueous shunts). (Response 2) This comment is supportive of the reclass ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 27k characters. 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