Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer

Food and Drug Administration, HHS.

Proposed amendment; proposed order; request for comments.

The Food and Drug Administration (FDA) is proposing to reclassify diagnostic endoscopic light source systems (product code OAY), which are postamendments class III devices, from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name "Cystoscopic system intended as an aid for detection of bladder cancer," along with special controls that FDA believes are necessary to provide a reasonable assurance of the safety and effectiveness of these devices.

Either electronic or written comments on the proposed order must be submitted by October 16, 2026. Please see Section X of this document for the proposed effective date when the new requirements would apply and for the proposed effective date of a final order based on this proposed order.

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 16, 2026. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.

Electronic Submissions

Submit electronic comments in the following way: Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see "Written/Paper Submissions" and "Instructions").

Written/Paper Submissions

Submit written/paper submissions as follows: Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in "Instructions." Instructions: All submissions received must include the Docket No. FDA-2026-N-8249 for "Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer." Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION." FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as "confidential." Any information marked as "confidential" will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf . Docket: For access to the docket to read background documents, the plain language summary of the proposed order of not more than 100 words consistent with the "Providing Accountability Through Transparency Act," or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the "Search" box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

Esther Kaplan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2604, Silver Spring, MD 20993, 301-796-1863, [email protected].

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) establishes three classes of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three classes of devices are class I (general controls), class II (special controls), and class III (premarket approval). Section 513(a)(1) of the FD&C Act defines the three classes of devices. Class I devices are those devices for which the general controls of the FD&C

Act (controls authorized by or under sections 501, 502, 510, 516, 518, 519, or 520 (21 U.S.C. 351, 352, 360, 360f, 360h, 360i, or 360j) or any combination of such sections) are sufficient to provide reasonable assurance of safety and effectiveness of the device; or those devices for which insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of safety and effectiveness or to establish special controls to provide such assurance, but because the devices are not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and do not present a potential unreasonable risk of illness or injury, are to be regulated by general controls (section 513(a)(1)(A) of the FD&C Act). Class II devices are those devices for which general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, and for which there is sufficient information to establish special controls to provide such assurance, including the issuance of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions FDA (the Agency or we) deems necessary to provide such assurance (section 513(a)(1)(B) of the FD&C Act). Class III devices are those devices for which insufficient information exists to determine that general controls and special controls would provide a reasonable assurance of safety and effectiveness, and are purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury (section 513(a)(1)(C) of the FD&C Act). Devices that were not introduced or delivered for introduction into interstate commerce for commercial distribution before 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 action. Those devices remain in class III and require approval of a premarket approval application (PMA), unless and until: (1) FDA reclassifies the device into class I or 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 predicate devices by means of the premarket notification procedures in section 510(k) of the FD&C Act and part 807, subpart E, of FDA's regulations (21 CFR part 807, subpart E). A postamendments device that has initially been 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. Section 513(f)(3) of the FD&C Act 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 proposed new class must have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use.\1\

\1\ See generally section 513 of the FD&C Act.

FDA relies on "valid scientific evidence," as stated in section 513(a)(3) of the FD&C Act and defined in 21 CFR 860.7(c)(2), in the classification process to determine the level of regulation for devices.\2\ In general, to be considered in the reclassification process, the "valid scientific evidence" on which the Agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information; e.g., the contents of a pending PMA (see section 520(c) of the FD&C Act). 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.

\2\ See generally id.

In accordance with section 513(f)(3) of the FD&C Act, the Agency is issuing this proposed order to reclassify postamendments class III diagnostic endoscopic light source systems intended for use with an approved optical imaging agent for photodynamic blue light cystoscopy as an adjunct to white light cystoscopy for the detection of known or suspected bladder cancer, including carcinoma in situ, or in patients undergoing surveillance cystoscopy for bladder cancer (product code OAY),\3\ hereinafter referred to as cystoscopic systems intended as an aid for detection of bladder cancer, into class II (special controls), subject to premarket notification, under a new device classification regulation with the name "Cystoscopic system intended as an aid for detection of bladder cancer."

\3\ FDA's Center for Devices and Radiological Health (CDRH) uses product codes to assist in accurate identification and tracking of current medical devices and to allow for tracking of and easy reference to predicate device types. CDRH and a subset of Center for Biologics Evaluation and Research regulated medical device product codes consist of a three-letter combination that associates a device's type with a product classification designated for the application. There is no definitive meaning for the three-digit classification product codes in CDRH's Product Classification Database. See FDA guidance titled "Medical Device Classification Product Codes," available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-classification-product-codes-guidance-industry-and-food-and-drug-administration-staff.

Based on the PMA data available to FDA in accordance with section 520(h)(4) of the FD&C Act,4 5 published peer-reviewed literature, data and information from a public meeting of the Oncologic Drugs Advisory Committee (ODAC) held on December 17, 2009, to discuss NDA 022555 for CYSVIEW (hexaminolevulinate hydrochloride) for Intravesical Solution \6\ (CYSVIEW (hexaminolevulinate hydrochloride)) for use with the Karl Storz Photodynamic Diagnostic D-Light C System (PDD System) (P050027), a cystoscopic system intended as an aid for detection of bladder cancer, and data available to the Agency demonstrating a lack of significant postmarket safety signals, FDA believes there is sufficient information to reclassify cystoscopic systems intended as an aid for detection of bladder cancer from class III (premarket approval) into class II (special controls).

\4\ In proposing to reclassify, on its own initiative, cystoscopic systems intended as an aid for the detection of bladder cancer from class III to class II, FDA is relying on data from the relevant PMA available to FDA in accordance with the six-year rule (see section 520(h)(4) of the FD&C Act) (see also, FDA's guidance titled "Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997--Guidance for Industry and for FDA Reviewers"), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-section-216-food-and-drug-administration-modernization-act-1997-guidance-industry-and-fda. This data was from a PMA approved after November 28, 1990, and before July 24, 2020, for this specific proposed reclassification as noted in section II of this proposed order. See also FDA's premarket approval database, available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm. \5\ For the purpose of this proposed order, PMA data considered in accordance with section 520(h)(4) includes only that data which was submitted to and therefore considered by FDA at the time the PMA was reviewed and approval was issued. \6\ At the time of the ODAC meeting, the proposed trade name for the cross-labeled drug was HEXVIX (hexaminolevulinate hydrochloride) Kit.

FDA believes the standard in section 513(a)(1)(B) of the FD&C Act is met as general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of these devices, and there is sufficient information to establish special controls, which, in addition to general controls, would provide reasonable assurance of the safety and effectiveness of these devices.\7\ Therefore, FDA is proposing to establish a new device classification regulation, "Cystoscopic system intended as an aid for detection of bladder cancer," and classify this device type into class II along with the special controls that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of these devices.

\7\ FDA notes that the "ACTION" caption for this proposed order is styled as "Proposed amendment; proposed order; request for comments," rather than "Proposed order." Beginning in December 2019, this editorial change was made to indicate that the document, if finalized, will amend the Code of Federal Regulations. The change was made in accordance with the Office of the Federal Register's (OFR) interpretations of the Federal Register Act (44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and parts 21 and 22), and the Document Drafting Handbook.

Under the FD&C Act, premarket notification (510(k)) submissions are required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt from 510(k) requirements under section 510(m) of the FD&C Act.\8\ FDA has not made this determination for cystoscopic systems intended as an aid for detection of bladder cancer, and therefore, FDA is not proposing that this class II device type be exempt from 510(k) requirements. If this proposed order is finalized, persons who intend to market this type of device will have to submit to FDA a premarket notification under section 510(k) of the FD&C Act and receive clearance prior to marketing the device.

\8\ In considering whether to exempt class II devices from premarket notification, FDA considers whether premarket notification for the type of device is necessary to provide reasonable assurance of safety and effectiveness of the device. FDA generally considers the factors initially identified in the January 21, 1998, Federal Register notice (63 FR 3142) and further explained in FDA's guidance issued on February 19, 1998, titled "Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff," available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff, in determining whether premarket notification is necessary for class II devices. FDA also considers that even when exempting devices from the 510(k) requirements, these devices would still be subject to certain limitations on exemptions, for example, the general limitations set forth in 21 CFR 876.9.

In accordance with section 513(f)(1) of the FD&C Act, cystoscopic systems intended as an aid for detection of bladder cancer were automatically classified into class III because they were not introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, have not been reclassified into class I or class II, and have not been found substantially equivalent to a device placed in commercial distribution after May 28, 1976, which was subsequently classified or reclassified into class II or class I. Therefore, they are subject to the PMA requirements under section 515 of the FD&C Act (21 U.S.C. 360e). On May 28, 2010, FDA approved an original PMA for the PDD System (P050027) (Ref. 1), which is the first approved cystoscopic system intended as an aid for detection of bladder cancer. The PDD System, when used in combination with the approved optical imaging drug CYSVIEW (hexaminolevulinate hydrochloride) (New Drug Application (NDA) 022555), was approved with an indication for photodynamic blue light cystoscopy, as an adjunct to white light cystoscopy for the detection of non-muscle invasive papillary cancer of the bladder in patients suspected or known to have the lesion on the basis of a prior cystoscopy (Ref. 1). The device is only to be used as an adjunct to white light cystoscopy (Ref. 2) and, therefore, is not intended to be used as the sole or definitive basis for diagnosis. Approval of the PMA for the PDD System occurred on the same day as the approval of the NDA for CYSVIEW (hexaminolevulinate hydrochloride), consistent with recommendations made by the ODAC. On December 17, 2009, the ODAC met to discuss the benefit/risk assessment for CYSVIEW \9\ (hexaminolevulinate hydrochloride), when used with the PDD System, for photodynamic blue light cystoscopy performed as an adjunct to white light cystoscopy in the detection of non-muscle invasive papillary cancer of the bladder in patients with known or suspected bladder cancer (Ref. 3). Discussion by the ODAC members included considerations applicable to the PDD System (e.g., the risk of false positives) as part of the combined use of the two products. The ODAC was presented with data that included results from a prospective, controlled clinical trial of adult subjects with known or suspected bladder cancer, as well as data from several supportive studies. The majority of ODAC members found that the data established a favorable diagnostic benefit-risk assessment for CYSVIEW (hexaminolevulinate hydrochloride) when used in combination with the PDD System for the detection of non-muscle invasive papillary cancer of the bladder in patients with known or suspected bladder cancer. Although several ODAC members expressed concerns about potential repetitive use of CYSVIEW (hexaminolevulinate hydrochloride), these concerns related to use of the drug and not specifically the PDD System. In a September 3, 2010, Federal Register notice (75 FR 54154), FDA announced the PMA approval order and the availability of the Summary of Safety and Effectiveness Data (SSED) for the device.

\9\ See FN 6.

FDA's approval of the PDD System included a postmarket study commitment for a prospective, randomized, controlled clinical study to assess the safety and efficacy of CYSVIEW (hexaminolevulinate hydrochloride) in the detection of carcinoma in situ of the bladder (Ref. 1).\10\ On February 15, 2018, FDA approved a PMA supplement to the PDD System (P050027/S011), supported by clinical data from the postmarket study results, which, among other things, added an additional subsystem that included a flexible video cystoscope and expanded the indications for use for the device to include use in combination with CYSVIEW (hexaminolevulinate hydrochloride) for detection of carcinoma in situ of the bladder and in patients undergoing surveillance cystoscopy for bladder cancer.\11\ The approval of this PMA supplement was consistent with changes to the labeling for CYSVIEW (hexaminolevulinate hydrochloride) approved on the same day (NDA 22555/S-005) (Ref. 4).

\10\ Postmarket study requirements also included a prospective, randomized, controlled clinical study to assess the safety and efficacy of CYSVIEW (hexaminolevulinate hydrochloride) for repetitive use. \11\ Additional information regarding this PMA supplement is discussed in a petition for reclassification submitted by the manufacturer of the PDD System on October 21, 2022, under Docket Number FDA-2022-P-2644.

As of the date of issuance of this proposed order, fewer than 6 years have passed since FDA's approval of certain other PMA supplements for the PDD System. Therefore, in accordance with the "six-year rule" described in section 520(h)(4) of the FD&C Act, no information from these documents has been used in support of this proposed

order to reclassify cystoscopic systems intended as an aid for detection of bladder cancer into class II. In addition, since the first approval order for a cystoscopic system intended as an aid for detection of bladder cancer, FDA has received no other original PMAs for this device type. On April 29, 2015, FDA published a notice in the Federal Register (80 FR 23798) titled "Retrospective Review of Premarket Approval Application Devices; Striking the Balance Between Premarket and Postmarket Data Collection." This notice announced the Center for Devices and Radiological Health's progress on its 2014-2015 strategic priority, "Strike the Right Balance Between Premarket and Postmarket Data Collection" (Ref. 5). As part of that strategic priority, FDA was at that time conducting a retrospective review of all PMA product codes with active PMAs approved prior to 2010 to determine whether, in light of FDA's then-current understanding of the technology, there may be sufficient information to establish special controls to provide a reasonable assurance of safety and effectiveness for these devices, together with general controls, supporting reclassification of these devices from class III to class II. FDA solicited comments on certain product codes that had been identified at that time, including devices in product code OAY, as candidates for reclassification (Ref. 6). FDA received no comments on the notice about the potential reclassification of devices in product code OAY. In October 2022, FDA received a petition from the manufacturer of the PDD System requesting that FDA reclassify devices under product code OAY from class III to class II (the Reclassification Petition) (Docket No. FDA-2022-P-2644). In February 2024, the petitioner submitted a potential draft special control guidance document for devices under product code OAY for FDA to consider. FDA also heard from health care practitioners, patients, medical device manufacturers, a patient advocacy organization, and the holder of the NDA for CYSVIEW (hexaminolevulinate hydrochloride) in connection with the Reclassification Petition, who were in favor of reclassifying devices under product code OAY from class III to class II.\12\ On March 27, 2026, FDA denied the Reclassification Petition, as FDA did not agree that the information provided and the special controls proposed by the petitioner supported reclassification from class III to class II.

\12\ See Docket No. FDA-2022-P-2644 available at: https://www.regulations.gov/docket/FDA-2022-P-2644.

As discussed in this proposed order, FDA is now proposing, on its own initiative, to reclassify cystoscopic systems intended as an aid for detection of bladder cancer from class III to class II. FDA has considered the information available to the Agency and believes that there is sufficient information available to establish special controls and that the special controls proposed in section VII of this document, together with general controls, would provide a reasonable assurance of the safety and effectiveness of devices under product code OAY. A review of data from FDA's Manufacturer and User Facility Device Experience (MAUDE) database, which contains Medical Device Reports (MDRs) of adverse events, indicates that as of April 30, 2026, there have been 11 unique MDRs associated with product code OAY. Most of the adverse events were related to thermal injury from contact with the light cable. One adverse event was related to user injury, a cut, from a damaged device. Two MDRs reported that the blue light mode stopped working after the first use. Based on a search of FDA's Medical Device Recalls database using product code OAY, as of June 15, 2026, there has been one recall involving a cystoscopic system intended as an aid for detection of bladder cancer. The recall was initiated by the device manufacturer on August 16, 2012, and was reported to be due to the system's instruction manuals containing a labeling error. The correction applied to the three component manuals indicated for use within the device. To address the labeling error, a Safety Alert letter was sent to all customers to inform them that there was a labeling error, including instructions on how to correct the error. The recall was classified as a class II \13\ recall and was terminated by FDA on May 8, 2013.\14\ FDA is not aware of any injuries related to this recall. These facts, coupled with the low number of MDRs, indicate a lack of significant postmarket safety signals for this device type. FDA believes the special controls proposed herein, in addition to general controls, can effectively mitigate the risks to health identified in this document to provide a reasonable assurance of the safety and effectiveness of cystoscopic systems intended as an aid for detection of bladder cancer.

\13\ Class I, II, and III recalls are defined in 21 CFR 7.3(m). \14\ For details about termination of a recall, see 21 CFR 7.55.

A cystoscopic system intended as an aid for detection of bladder cancer is a postamendments device classified into class III under section 513(f)(1) of the FD&C Act. A cystoscopic system intended as an aid for detection of bladder cancer is a prescription device intended for use with an approved optical imaging agent for photodynamic blue light cystoscopy, as an adjunct to white light cystoscopy for the detection of bladder cancer, including carcinoma in situ, in patients suspected or known to have the lesion on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for bladder cancer. The device is not intended as the sole or definitive basis for diagnosis. The device system includes a cystoscope and accessories, including a light source, camera system, fluid light cables, and software. The device can be used in white light or blue light modes. The blue light mode is used to view tissue fluorescence, either via the eyepiece on the scope or on a video monitor, after application of an approved optical imaging agent. The optical imaging agent reacts with the bladder lesions to provide visualization under blue light through the cystoscope. As discussed in section VI of this document, tissue fluorescence observation under blue light offers enhanced detection of potential bladder cancer compared to tissue observation under white light. FDA is proposing to reclassify cystoscopic systems intended as an aid for detection of bladder cancer from class III (premarket approval) to class II (special controls) and to establish a new name for the device type as described within the classification regulations. FDA proposes to revise 21 CFR part 876 to create a new device classification regulation with the name "Cystoscopic system intended as an aid for detection of bladder cancer." The Agency believes that this name and the identification language included in this proposed order more accurately describes this device type.

In accordance with section 513(f)(3) of the FD&C Act and 21 CFR part 860, subpart C, FDA is proposing to reclassify cystoscopic systems intended as an aid for detection of bladder cancer, which are postamendments devices, from class III into class II, subject to section 510(k) of the FD&C Act. FDA believes that there is sufficient data and information available to FDA

through the data and information provided in the original PMA (P050027) and one PMA supplement (P050027/S011) for the PDD System that may be considered under section 520(h)(4) of the FD&C Act, the ODAC materials, published peer-reviewed literature, and FDA's publicly available MAUDE and Medical Device Recalls databases to establish special controls (Refs. 3 and 7 to 14). More specifically, in evaluating these data sources, FDA has identified the risks to health for inclusion in the overall risk assessment for a cystoscopic system intended as an aid for detection of bladder cancer and is proposing special controls that include mitigation measures for each of the risks to health identified in section V. FDA believes that these special controls, together with general controls, would effectively mitigate the risks to health identified in section V and are necessary to provide a reasonable assurance of safety and effectiveness of these devices. FDA does not believe that the general controls applicable to the devices are sufficient to effectively mitigate the risks to health identified for these devices, such as the risk of additional biopsies from false positive results or delayed diagnosis due to false negative results and, therefore, does not believe that the general controls applicable to the devices are sufficient to provide reasonable assurance of the safety and effectiveness of these devices. FDA is proposing to revise 21 CFR part 876 to create a new device classification regulation with the name "Cystoscopic system intended as an aid for detection of bladder cancer." Under this proposed order, if finalized, cystoscopic systems intended as an aid for detection of bladder cancer will be identified as prescription devices. If the proposed order is finalized, these devices will be subject to the prescription labeling requirements for devices (see 21 CFR 801.109). Under the FD&C Act, 510(k) submissions are required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt from 510(k) requirements under section 510(m) of the FD&C Act.\15\ FDA has not made this determination for cystoscopic systems intended as an aid for detection of bladder cancer, and therefore FDA is not proposing that these proposed class II devices be exempt from 510(k) requirements. If this proposed order is finalized, persons who intend to market a cystoscopic system intended as an aid for detection of bladder cancer will need to submit a 510(k) to FDA and receive clearance prior to marketing the device.

\15\ See supra note 8.

This proposed order, if finalized, will decrease regulatory burden on industry, as manufacturers will no longer have to submit a PMA for this type of device but can instead submit a 510(k) to the Agency for review prior to marketing their device. The 510(k) pathway is less burdensome and generally more cost-effective for industry and FDA than the PMA pathway, the most stringent type of device marketing pathway. A 510(k) typically results in a shorter premarket review timeline compared to a PMA, which ultimately may provide more timely patient access for this type of device. FDA expects that the reclassification of these devices would enable more manufacturers to develop this type of device such that patients would benefit from increased access to appropriately safe and effective devices used adjunctively to detect bladder cancer. Additionally, manufacturers may wish to use predetermined change control plans (PCCPs) as a way to implement future modifications to their devices without needing to submit a new 510(k) for each significant change or modification \16\ while continuing to provide a reasonable assurance of device safety and effectiveness.\17\ FDA reviews a PCCP as part of a marketing submission for a device to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification to the device as described in the PCCP. When used appropriately, PCCPs authorized by FDA are expected to be least burdensome for manufacturers and FDA.\18\

\16\ For the purpose of this proposed order, reference to "modification" means a significant change or modification that would generally require a new premarket notification under 21 CFR 807.81(a)(3). \17\ Section 3308 of the Food and Drug Omnibus Reform Act of 2022, Title III of Division FF of the Consolidated Appropriations Act, 2023, Public Law 117-328 (FDORA), enacted on December 29, 2022, added section 515C "Predetermined Change Control Plans for Devices" to the FD&C Act (21 U.S.C. 360e-4). Section 515C has provisions regarding PCCPs for devices requiring premarket approval or premarket notification. Under section 515C, supplemental applications (section 515C(a)) and new premarket notifications (section 515C(b)) are not required for a change to a device that would otherwise require a premarket approval supplement or new premarket notification if the change is consistent with a PCCP approved or cleared by FDA. \18\ Sections 513 and 515 of the FD&C Act. See also, FDA's guidance titled "The Least Burdensome Provisions: Concept and Principles," available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles.