Medical Devices; Quality Management System Regulation Technical Amendments

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Parts 801, 803, 812, 860, 862, 864, 866, 868, 872, 874, 876, 878, 880, 882, 886, 888, 890, and 892</CFR> <DEPDOC>[Docket No. FDA-2025-N-4635]</DEPDOC> <SUBJECT>Medical Devices; Quality Management System Regulation Technical Amendments</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Final rule; technical amendments. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA, the Agency, or we) is amending certain medical device regulations to revise references and language in existing Code of Federal Regulations (CFR) provisions to conform with the final rule “Medical Devices; Quality System Regulation Amendments” (QMSR Final Rule). This rule does not impose any new requirements on affected parties. This action is editorial in nature to correct errors, conform regulatory references, and ensure accuracy and clarity in the Agency's regulations. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective February 2, 2026. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Daniel Schieffer, Office of Policy, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 5562, Silver Spring, MD 20993, 301-796-3350, <E T="03">Daniel.Schieffer@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> As a part of this technical amendment, FDA is making changes to 21 CFR parts 801, 803, 812, 860, 862, 864, 866, 868, 872, 874, 876, 878, 880, 882, 886, 888, 890, and 892 to revise existing regulatory provisions for consistency with the QMSR Final Rule  <SU>1</SU> <FTREF/> to correct errors, conform regulatory references, and ensure accuracy and clarity in the Agency's medical device regulations. The changes published in this notice are non-substantive and editorial in nature. <FTNT> <SU>1</SU>  In this technical amendment, FDA uses the terms below in the following manner: when referring to 21 CFR part 820 as amended and effective on February 2, 2026, FDA uses the terms “Quality Management System Regulation” or “QMSR.” When referring to the regulation at 21 CFR part 820 in effect before February 2, 2026, FDA uses the terms “Quality System Regulation” or “QSR.” </FTNT> On February 2, 2024, FDA issued the QMSR Final Rule. This rule amended the device current good manufacturing practice (CGMP) requirements of the Quality System Regulation (QSR) to harmonize and modernize the regulation. The QMSR incorporates by reference an international standard for device quality management systems (ISO 13485:2016, Medical devices—Quality management systems—Requirements for regulatory purposes) and establishes additional requirements and provisions that clarify certain expectations and concepts used in ISO 13485. The purpose of this technical amendment is to update references from the QSR in existing FDA regulations to references to the QMSR that becomes effective on February 2, 2026, and to correct errors and ensure consistency and clarity in FDA's regulations. <HD SOURCE="HD1">II. Description of the Technical Amendments</HD> We are amending 179 sections of Title 21 of the CFR, spread throughout 18 parts, in this technical amendment. Each section that is being modified includes a change to conform existing regulations for consistency with the QMSR. FDA is also clarifying the authority citations for three parts. The changes made in this technical amendment can be summarized as follows: • One hundred and sixty-two of these amendments change the wording in the classification regulations for certain class I device types. <SU>2</SU> <FTREF/> Specifically, these classification regulations currently exempt their respective devices, with various qualifications depending on the device, from the majority of the QSR. The QSR provisions that are not exempted in all of these sections (except one  <SU>3</SU> <FTREF/> ) are §§ 820.180 and 820.198 (21 CFR 820.180 and 820.198). This amendment updates the references to the non-exempted activities for these devices from §§ 820.180 (Records—General requirements) and 820.198 (Records—Complaint files) in the QSR to the equivalent requirement in the QMSR (§ 820.35 (Control of Records) (21 CFR 820.35)). <FTNT> <SU>2</SU>  Class I devices are those devices for which the general controls within the Federal Food, Drug, and Cosmetic Act (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; 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 (21 U.S.C. 360c(a)(1)(A))). </FTNT> <FTNT> <SU>3</SU>  Section 864.3260(b) (21 CFR 864.3260(b)) currently exempts over-the-counter (OTC) test sample collection systems for drugs of abuse testing, if the device is not labeled or otherwise represented as sterile, from all of the QSR except for § 820.198. </FTNT> • Section 801.30(a)(2) (21 CFR 801.30(a)(2)), which is a specific exemption to the unique device identification requirement, is being modified in the same way as the classification regulations in the preceding bullet by changing references from §§ 820.180 and 820.198 in the QSR to the equivalent requirement in the QMSR (§ 820.35). • In the classification regulation for the Keratoscope (§ 886.1350(b) (21 CFR 886.1350(b))), in addition to the updated language described in the first bullet, we are also adding the words “Classification. Class I (general controls).” This is because the statement that the device was classified as class I  <SU>4</SU> <FTREF/> was inadvertently deleted from the CFR when the section was last edited in 2000. <SU>5</SU> <FTREF/> <FTNT> <SU>4</SU>  55 FR 48436 at 48438. </FTNT> <FTNT> <SU>5</SU>  See 65 FR 2296 at 2320. </FTNT> • Nine class II classification regulations  <SU>6</SU> <FTREF/> are being modified to change references to § 820.30 (Design Controls) (21 CFR 820.30) in the QSR to the equivalent provision in the QMSR (§ 820.10(c) (21 CFR 820.10(c))). <FTNT> <SU>6</SU>  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 the Agency deems necessary to provide such assurance (section 513(a)(1)(B) of the FD&C Act). </FTNT> • In part 812 (Investigational Device Exemptions) an additional two sections (§§ 812.1(a) and 812.35(a)(3)(iii)(A) (21 CFR 812.1(a) and 812.35(a)(3)(iii)(A))) are being modified to also change references from § 820.30 in the QSR to the equivalent provision in the QMSR (§ 820.10(c)). A second revision to § 812.35 revises § 812.35(a)(3)(iv)(A) to insert a clarifying reference to § 820.10(c) of the QMSR. • One change in § 801.45(e) (21 CFR 801.45(e)) changes a reference from the design history file in the QSR to the design and development files of the QMSR. • Four sections are modified in this technical amendment by updating the phrase “quality system regulation” to the phrase “quality management system regulation.” • FDA is clarifying the authority citations in parts 862, 876, and 878 to italicize the `l' in 21 U.S.C. 360 <E T="03">l</E> to more clearly distinguish it from a numeral 1. In some of the edited sections we have also made minor wording changes to standardize language across sections and/or correct non-substantive typographic errors. The changes to all 179 sections are non-substantive and are intended to conform existing regulations to the requirements in the QMSR that mirror the requirements in the QSR. This rule does not impose any new regulatory requirements on affected parties. The amendments are editorial in nature and should not be construed as modifying any substantive standards or requirements. <HD SOURCE="HD1">III. Notice and Public Comment</HD> Publication of this document constitutes final action under the Administrative Procedure Act (APA) (5 U.S.C. 551-559). Section 553 of the APA generally exempts “rules of agency organization, procedure, or practice” from proposed rulemaking ( <E T="03">i.e.,</E> notice and comment rulemaking) (5 U.S.C. 553(b)(4)(A)). Rules are also exempt when an agency finds “good cause” that notice and comment rulemaking procedures would be “impracticable, unnecessary, or contrary to the public interest” (5 U.S.C. 553(b)(4)(B)). FDA has determined that this rulemaking meets the APA's notice and comment exemption requirements under 5 U.S.C. 553(b)(4)(B). All the revisions in this rule are technical or non-substantive changes. These revisions update the language in certain regulations to be consistent with other regulations and the FD&C Act without changing the actions required under the regulations. Such technical, non-substantive changes are “a routine determination, insignificant in nature and impact, and inconsequential to th ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 145k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━