AD 2026-18-10
Applicability
| Type | Manufacturer | Model | Details |
|---|---|---|---|
| aircraft | Textron | Canada Limited | Airworthiness Directives; Bell Textron Canada Limited Helicopters |
| aircraft | Bell | Textron Canada Limited | Airworthiness Directives; Bell Textron Canada Limited Helicopters |
Unsafe Condition
The identification plate on certain tail cone assemblies has an incorrect part number (P/N), which may not accurately convey the life limit.
AI-generated summary from the source AD text. Verify against the official source before acting.
Required Actions
Verify the tail cone assembly part number and replace the incorrect identification plate with a new one containing the correct P/N. Update the existing log book or equivalent record.
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Affected Aircraft
Bell Textron Canada Limited Model 505 helicopters affected by the incorrect part number on tail cone assemblies.
AI-generated summary from the source AD text. Verify against the official source before acting.
Federal Register Abstract
The FAA is adopting a new airworthiness directive (AD) for certain Bell Textron Canada Limited Model 505 helicopters. This AD was prompted by reports that the identification plate affixed to certain tail cone assemblies contains an incorrect part number (P/N), which may not accurately convey the life limit. This AD requires verifying the tail cone assembly part number and, if necessary, replacing the incorrect tail cone assembly identification plate with a new tail cone assembly identification plate containing the correct P/N and updating the existing log book or equivalent record for the helicopter. The FAA is issuing this AD to address the unsafe condition on these products.
Document Text
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58814 Federal Register / Vol. 91, No. 179 / Thursday, September 17, 2026 / Rules and Regulations responsibilities among the various levels of government. For the reasons discussed above, I certify that this AD: (1) Is not a ‘‘significant regulatory action’’ under Executive Order 12866, (2) Will not affect intrastate aviation in Alaska, and (3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. The Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES ■ 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] ■ 2. The FAA amends § 39.13 by adding the following new airworthiness directive: 2026–18–09 Airbus SAS: Amendment 39– 23464; Docket No. FAA–2026–7201; Project Identifier MCAI–2025–01290–T. (a) Effective Date This airworthiness directive (AD) is effective October 22, 2026. (b) Affected ADs None. (c) Applicability This AD applies to all Airbus SAS Model A330–243, A330–243F, A330–341, A330– 342, and A330–343 airplanes, certificated in any category. (d) Subject Air Transport Association (ATA) of America Code 71, Power Plant. (e) Unsafe Condition This AD was prompted by reports of cracked and broken restraint brackets of the anti-ice piccolo tube found during maintenance on affected parts. The FAA is issuing this AD to address the unsafe condition which, if not addressed, could result in a thermal anti-ice feed pipe disengagement and decrease the effectiveness of the thermal anti-ice system, allowing ice build-up on the inlet lip skin, which could result in damage to the engine and reduced control of the airplane. (f) Compliance Comply with this AD within the compliance times specified, unless already done. (g) Requirements Except as specified in paragraphs (h) and (i) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, European Union Aviation Safety Agency (EASA) AD 2025– 0164, dated July 29, 2025 (EASA AD 2025– 0164). (h) Exceptions to EASA AD 2025–0164 (1) Where EASA AD 2025–0164 refers to its effective date, this AD requires using the effective date of this AD. (2) Where EASA AD 2025–0164 defines a serviceable part as a ‘‘Nacelle Inlet Cowl, eligible for installation in accordance with Airbus instructions, which is not an affected part’’, for this AD replace that text with ‘‘Nacelle Inlet Cowl, eligible for installation, which is not an affected part’’. (3) Where paragraph (3) of EASA AD 2025– 0164 specifies ‘‘any discrepancy, as identified in the SB, is found on an affected part’’, this AD requires replacing that text with ‘‘any discrepancy is found on an affected part’’. (4) This AD does not adopt the ‘‘Remarks’’ section of EASA AD 2025–0164. (i) No Reporting Requirement Although the material referenced in EASA AD 2025–0164 specifies to submit certain information to the manufacturer, this AD does not include that requirement. (j) Additional AD Provisions The following provisions also apply to this AD: (1) Alternative Methods of Compliance (AMOCs): The Manager, AIR–520, Continued Operational Safety Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or responsible Flight Standards Office, as appropriate. If sending information directly to the manager of the Continued Operational Safety Branch, send it to the attention of the person identified in paragraph (k) of this AD and email to: AMOC@faa.gov . Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the responsible Flight Standards Office. (2) Contacting the Manufacturer: For any requirement in this AD to obtain instructions from a manufacturer, the instructions must be accomplished using a method approved by the Manager, AIR–520, Continued Operational Safety Branch, FAA; or EASA; or Airbus SAS’s EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA- authorized signature. (3) Required for Compliance (RC): Except as required by paragraphs (i) and (j)(2) of this AD, if any material contains procedures or tests that are identified as RC, those procedures and tests must be done to comply with this AD; any procedures or tests that are not identified as RC are recommended. Those procedures and tests that are not identified as RC may be deviated from using accepted methods in accordance with the operator’s maintenance or inspection program without obtaining approval of an AMOC, provided the procedures and tests identified as RC can be done and the airplane can be put back in an airworthy condition. Any substitutions or changes to procedures or tests identified as RC require approval of an AMOC. (k) Additional Information For more information about this AD, contact Anthony Decaro, Aviation Safety Engineer, FAA, 2200 South 216th St., Des Moines, WA 98198; phone: 562–627–5374; email: Anthony.D.Decaro@faa.gov. (l) Material Incorporated by Reference (1) The Director of the Federal Register approved the incorporation by reference of the material listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51. (2) You must use this material as applicable to do the actions required by this AD, unless this AD specifies otherwise. (i) European Union Aviation Safety Agency (EASA) AD 2025–0164, dated July 29, 2025. (ii) [Reserved] (3) For EASA material identified in this AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email ADs@easa.europa.eu. You may find this material on the EASA website at ad.easa.europa.eu. (4) You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206–231–3195. (5) You may view this material at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ ibr-locations or email fr.inspection@nara.gov . Issued on September 3, 2026. Brian Knaup, Acting Deputy Director, Integrated Certificate Management Division, Aircraft Certification Service. [FR Doc. 2026–19084 Filed 9–16–26; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA–2026–4658; Project Identifier MCAI–2026–00014–R; Amendment 39–23465; AD 2026–18–10] RIN 2120–AA64 Airworthiness Directives; Bell Textron Canada Limited Helicopters AGENCY : Federal Aviation Administration (FAA), DOT. ACTION : Final rule. VerDate Sep<11>2014 15:39 Sep 16, 2026 Jkt 268001 PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 E:\FR\FM\17SER1.SGM 17SER1 lotter on DSK8BHNXB4PROD with RULES1 58815 Federal Register / Vol. 91, No. 179 / Thursday, September 17, 2026 / Rules and Regulations SUMMARY : The FAA is adopting a new airworthiness directive (AD) for certain Bell Textron Canada Limited Model 505 helicopters. This AD was prompted by reports that the identification plate affixed to certain tail cone assemblies contains an incorrect part number (P/N), which may not accurately convey the life limit. This AD requires verifying the tail cone assembly part number and, if necessary, replacing the incorrect tail cone assembly identification plate with a new tail cone assembly identification plate containing the correct P/N and updating the existing log book or equivalent record for the helicopter. The FAA is issuing this AD to address the unsafe condition on these products. DATES : This AD is effective October 22, 2026. The Director of the Federal Register approved the incorporation by reference of certain publication listed in this AD as of October 22, 2026. ADDRESSES : AD Docket: You may examine the AD docket at regulations.gov under Docket No. FAA–2026–4658; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this final rule, the mandatory continuing airworthiness information (MCAI), any comments received, and other information. The address for Docket Operations is U.S. Department of Transportation, Docket Operations, M– 30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE, Washington, DC 20590. Material Incorporated by Reference: • For Transport Canada material identified in this AD, contact Transport Canada, Transport Canada National Aircraft Certification, 159 Cleopatra Drive, Nepean, Ontario, K1A 0N5, Canada; phone: (888) 663–3639; email: TC.AirworthinessDirectives- Consignesdenavigabilite.TC@tc.gc.ca; website: tc.canada.ca/en/aviation. • You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 10101 Hillwood Parkway, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222–5110. It is also available at regulations.gov under Docket No. FAA–2026–4658. FOR FURTHER INFORMATION CONTACT : Brande Ali-Turner, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (847) 294–7132; email: brande.ali- turner@faa.gov . SUPPLEMENTARY INFORMATION : Background The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bell Textron Canada Limited Model 505 helicopters. The NPRM was published in the Federal Register on June 22, 2026 (91 FR 37057). The NPRM was prompted by Transport Canada AD CF–2026–01, dated January 12, 2026 (Transport Canada AD CF– 2026–01) (also referred to as the MCAI), issued by Transport Canada, which is the aviation authority for Canada. The MCAI states that there are reports that the identification plate affixed to some Bell 505 helicopter tail cone assemblies (P/N SLS–030–600–007 and P/N SLS– 030–600–009) mistakenly contains an incorrect P/N. The MCAI further states that the tail cone assembly is subject to a life limit published in the Airworthiness Limitations Schedule, and if the P/N on the identification plate remains uncorrected, it could be incorrectly determined that the tail cone assembly has an unlimited airworthiness life. If the tail cone assembly is not replaced because of the incorrect identification plate, it could lead to fatigue cracking of the tailboom and loss of control of the helicopter. In the NPRM, the FAA proposed to require verifying the tail cone assembly part number and, if necessary, replacing the incorrect tail cone assembly identification plate with a new tail cone assembly identification plate containing the correct P/N and updating the existing log book or equivalent record for the helicopter. The FAA is issuing this AD to address the unsafe condition on these products. You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA–2026–4658. Discussion of Final Airworthiness Directive Comments The FAA received no comments on the NPRM or on the determination of the costs. Conclusion These products have been approved by the civil aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA’s bilateral agreement with this State of Design Authority, that authority has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator. Material Incorporated by Reference Under 1 CFR Part 51 The FAA reviewed Transport Canada AD CF–2026–01, which specifies procedures for verifying and, if necessary, replacing the tail cone assembly identification plate with a new plate marked with the correct part number. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section. Costs of Compliance The FAA estimates that this AD would affect 182 helicopters of U.S. registry. The FAA estimates the following costs to comply with this AD: E STIMATED C OSTS Action Labor cost Parts cost Cost per product Cost on U.S. operators Verify tail cone assembly part number .................... 1 work-hour × $85 per hour = $85 ................ $0 $85 $15,470 The FAA estimates the following costs to do any replacement that will be required based on the results of the inspection. The agency has no way of determining the number of helicopters that might need this replacement. VerDate Sep<11>2014 15:39 Sep 16, 2026 Jkt 268001 PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 E:\FR\FM\17SER1.SGM 17SER1 lotter on DSK8BHNXB4PROD with RULES1 58816 Federal Register / Vol. 91, No. 179 / Thursday, September 17, 2026 / Rules and Regulations O N -C ONDITION C OSTS Action Labor cost Parts cost Cost per product Replace tail cone assembly identification plate ........................ 2 work-hours × $85 per hour = $170 .................. $5 $175 Update existing log book ........................................................... 1 work-hour × $85 per hour = $85 ...................... 0 85 The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected operators. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA’s authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency’s authority. The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that this AD: (1) Is not a ‘‘significant regulatory action’’ under Executive Order 12866, (2) Will not affect intrastate aviation in Alaska, and (3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. The Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES ■ 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] ■ 2. The FAA amends § 39.13 by adding the following new airworthiness directive: 2026–18–10 Bell Textron Canada Limited: Amendment 39–23465; Docket No. FAA–2026–4658; Project Identifier MCAI–2026–00014–R. (a) Effective Date This airworthiness directive (AD) is effective October 22, 2026. (b) Affected ADs None. (c) Applicability This AD applies to Bell Textron Canada Limited Model 505 helicopters, certificated in any category, as identified in Transport Canada AD CF–2026–01, dated January 12, 2026 (Transport Canada AD CF–2026–01) (d) Subject Joint Aircraft System Component (JASC) Code 5302, Rotorcraft tail boom. (e) Unsafe Condition This AD was prompted by reports that the identification plate affixed to certain tail cone assemblies contains an incorrect part number. The FAA is issuing this AD to ensure proper identification of the tail cone assembly and compliance with its approved life limit. The unsafe condition, if not addressed, could lead to non-replacement of the tail cone assembly within the life limit, which could result in possible fatigue cracking of the tailboom and loss of control of the helicopter. (f) Compliance Comply with this AD within the compliance times specified, unless already done. (g) Required Actions Except as specified in paragraph (h) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, Transport Canada AD CF– 2026–01. (h) Exceptions to Transport Canada AD CF– 2026–01 (1) Where Transport Canada AD CF–2026– 01 refers to its effective date, this AD requires using the effective date of this AD. (2) Where Transport Canada AD CF–2026– 01 requires compliance in terms of air time, this AD requires using hours time-in-service. (3) Where the material referenced in Transport Canada AD CF–2026–01 specifies scrapping or destroying certain parts, this AD requires removing those parts from service. (4) Where the material referenced in Transport Canada AD CF–2026–01 specifies making an entry in the helicopter’s log book and historical service records, this AD requires making an entry of the tail cone assembly part number and serial number of the replacement identification plate in the existing helicopter log book or equivalent document but you are not required to make an entry of compliance with the material. (i) Alternative Methods of Compliance (AMOCs) (1) The Manager, International Validation Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the International Validation Branch, send it to the attention of the person identified in paragraph (j) of this AD and email to: AMOC@faa.gov . (2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/ certificate holding district office. (j) Additional Information For more information about this AD, contact Brande Ali-Turner, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (847) 294– 7132; email: brande.ali-turner@faa.gov. (k) Material Incorporated by Reference (1) The Director of the Federal Register approved the incorporation by reference of the material listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51. (2) You must use this material as applicable to do the actions required by this AD, unless the AD specifies otherwise. (i) Transport Canada AD CF–2026–01, dated January 12, 2026. (ii) [Reserved] (3) For Transport Canada material identified in this AD, contact Transport Canada, Transport Canada National Aircraft Certification, 159 Cleopatra Drive, Nepean, Ontario, K1A 0N5, Canada; phone: (888) 663–3639; email: VerDate Sep<11>2014 15:39 Sep 16, 2026 Jkt 268001 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 E:\FR\FM\17SER1.SGM 17SER1 lotter on DSK8BHNXB4PROD with RULES1 58817 Federal Register / Vol. 91, No. 179 / Thursday, September 17, 2026 / Rules and Regulations 1 The Commission voted 3–0 to publish this notification. TC.AirworthinessDirectives- Consignesdenavigabilite.TC@tc.gc.ca. You may view this material on the Transport Canada website at tc.canada.ca/en/aviation. (4) You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 10101 Hillwood Parkway, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222–5110. (5) You may view this material at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ ibr-locations or email fr.inspection@nara.gov. Issued on September 10, 2026. Hollister B. Thorson, Acting Deputy Director, Compliance & Airworthiness Division, Aircraft Certification Service. [FR Doc. 2026–19052 Filed 9–16–26; 8:45 am] BILLING CODE 4910–13–P CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1500 [Docket No. CPSC–2026–0298] RIN 3041–AE17 Revocation of Obsolete Rules Regarding Infant Bouncer Seats and Stationary Activity Centers AGENCY : Consumer Product Safety Commission. ACTION : Withdrawal of direct final rule. SUMMARY : The U.S. Consumer Product Safety Commission (Commission or CPSC) is withdrawing a direct final rule that would remove two obsolete rules concerning infant bouncer seats and stationary activity centers that was published in the Federal Register on July 22, 2026, because the Commission received a significant adverse comment. DATES : The direct final rule published on July 22, 2026 (91 FR 45992) is withdrawn effective September 17, 2026. FOR FURTHER INFORMATION CONTACT : Daniel Taxier, Project Manager, U.S. Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850; telephone: (301) 987–2211; email: dtaxier@cpsc.gov. SUPPLEMENTARY INFORMATION : On July 22, 2026, the Commission published a direct final rule in the Federal Register that would remove two obsolete rules concerning infant bouncer seats and stationary activity centers because those products are subject to newer, more comprehensive mandatory safety standards issued by the Commission. 91 FR 45992. The Commission indicated in the direct final rule that if it received a significant adverse comment, the Commission would withdraw any portion of the direct final rule related to such a comment. The Commission received a significant adverse comment concerning the direct final rule and thus is withdrawing the direct final rule. 1 The Commission will consider the significant adverse comment and assess the appropriate manner in which to proceed in this matter. Alberta E. Mills, Secretary, Consumer Product Safety Commission. [FR Doc. 2026–19065 Filed 9–16–26; 8:45 am] BILLING CODE 6355–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 892 [Docket No. FDA–2025–P–5560] Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer- Aided Triage and Notification Devices AGENCY : Food and Drug Administration, HHS. ACTION : Final order. SUMMARY : The Food and Drug Administration (FDA) is publishing an order setting forth its final determination regarding a partial exemption from the premarket notification requirements for radiology computer-aided detection and/or diagnosis devices and computer-aided triage and notification devices that was the subject of a notice published in the Federal Register of December 29, 2025. That notice announced FDA’s receipt of a petition that requested exemption from the premarket notification requirements for the following generic device types when certain conditions described in the petition were met: radiological computer-assisted diagnostic software for lesions suspicious of cancer; medical image analyzers; radiological computer aided triage and notification software; and radiological computer-assisted detection and diagnosis software. FDA denied the petition in a response issued to the petitioner on April 1, 2026. FDA is publishing this order in accordance with procedures established by the Federal Food, Drug, and Cosmetic Act (FD&C Act). DATES : This order is effective September 17, 2026. FOR FURTHER INFORMATION CONTACT : Gugandeep Kaur, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5504, Silver Spring, MD 20993–0002, 240–402–9534. SUPPLEMENTARY INFORMATION : I. Background—Regulatory Authorities The 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 section 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, but for which there is sufficient information to establish special controls to provide such assurance, including the issuance of performance standards, post-market 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). VerDate Sep<11>2014 15:39 Sep 16, 2026 Jkt 268001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\17SER1.SGM 17SER1 lotter on DSK8BHNXB4PROD with RULES1
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