Standards, Guidance & Notices
Showing 1–10 of 76
FDA
CDRH
CDRH
FDA-2026-N-9505
Robotically-Assisted Surgical Devices - Premarket Submissions (Draft Guidance)
On September 25, 2026, FDA issued the draft guidance "Robotically-Assisted Surgical Devices - Premarket Submissions" (document number GUI01500081; Docket No. FDA-2026-N-9505). It covers teleoperated, software-controlled robotically-assisted surgical devices (RASDs) that assist qualified practitioners with open, minimally invasive or endoluminal procedures, and sets out recommendations on non-clinical testing, clinical data and labeling. Topics include substantial equivalence comparisons for 510(k) submissions, software verification and validation, reliability testing, cybersecurity, wireless coexistence (AAMI TIR69), human factors, and reprocessing validation. For cybersecurity, a RASD that meets the definition of a cyber device under section 524B(c) of the FD&C Act must meet the section 524B(b) requirements; the draft additionally recommends threat and vulnerability analysis and penetration testing that covers back-end infrastructure and remote access, including a simulated compromised hospital network. Remotely teleoperated and autonomous RASDs, and RASDs for placing or using interventional devices such as catheters, are out of scope; manufacturers of such devices are encouraged to use the Q-Submission Program. Comments are due within 60 days of the Federal Register notice, i.e. by November 24, 2026. Separately, CDRH will hold a public workshop on December 2-3, 2026 (in person and online) on benefit-risk evaluation of robotic devices with autonomous or remote teleoperation capabilities.
Published: 2026-09-25
EU
MDCG
MDCG
MDCG 2020-16 rev.5
Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
Revision 5 (September 2026) of the MDCG guidance on interpreting the classification rules in Annex VIII of the IVDR (Regulation (EU) 2017/746). It sets out the principles for classifying IVDs into classes A to D based on intended purpose and inherent risk, and provides the rationale and non-exhaustive examples for each of Rules 1 to 7. Software that drives or influences the use of a device falls within the same class as the device, while software independent of any other device is classified in its own right, with reference to MDCG 2019-11. Annexes provide examples of classifying IVDs used in combination and a flowchart to help determine whether an IVD is a companion diagnostic. Revision 5 clarifies the rationale of Rule 7 (controls without an assigned value) and revises its examples. The guidance is not legally binding.
Published: 2026-09-01
MHLW
Notice
Notice
MHLW-PFSB-MDED-0825-No.1
Guideline on the Introduction and Operation of SBOM for Medical Devices (1st Edition)
Guideline compiled under the FY2025 Medical Device Cybersecurity Promotion Project and circulated to industry by MHLW notice for reference. It covers all software contained in a medical device and sets out a stepwise adoption path according to organizational maturity: Stage 1 establishes the capability to create, update and change-manage SBOMs based on the NTIA minimum elements; Stage 2 integrates SBOMs into existing QMS and post-market safety processes, including vulnerability, license and EOL/EOS management, for lifecycle risk management. SPDX 2.2 or later and CycloneDX 1.6 or later are recommended for new adoption; where SWID is already in use, parallel use or conversion may be considered. As the disclosure baseline set by the guideline, manufacturers should be able to provide SBOMs to healthcare facilities, mainly at installation and upon significant software changes, and present them on request at least throughout the product support period. Intended readers span software development, quality assurance, regulatory affairs, PSIRT/information security and field service, as a shared cross-functional reference. Article 12(3) of the Essential Principles and FD&C Act Section 524B are cited as regulatory background.
Published: 2026-08-25
FDA
CDRH
CDRH
fda_20260819_Considerations_Regulation_Gene
Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback
A discussion paper and request for feedback from the FDA Digital Health Center of Excellence (DHCoE) within CDRH on the regulation of generative AI-enabled medical devices. The paper notes that these devices may carry risks that differ from those of traditional software and AI-enabled devices, and aims to engage stakeholders on the associated challenges. It covers four topics: (1) considerations for assessing risk, (2) considerations for premarket evaluation, (3) postmarket monitoring, and (4) other relevant topics. The paper is for discussion purposes only: it is neither draft nor final guidance and does not communicate proposed or final regulatory expectations of CDRH. Feedback from device manufacturers, clinicians, researchers, the public, and other interested parties is requested via docket FDA-2026-N-7874 on Regulations.gov, with a submission deadline of October 19, 2026. Respondents need not answer every question and may address only the topics relevant to their expertise.
Published: 2026-08-19
IMDRF
IMDRF/SaMD WG/N90 FINAL:2026
Essential Principles and Content of Predetermined Change Control Plans
Final document of the IMDRF Software as a Medical Device Working Group setting out high-level principles for Predetermined Change Control Plans (PCCPs), through which manufacturers can seek authorization in advance for certain planned modifications to medical device software (as defined in N81) that remain within the original intended use or intended purpose. It identifies five essential principles (focused and bounded, risk-based, evidence-based, transparent, and TPLC perspective) and three interconnected elements: Description of Changes, Change Plan (performance evaluation methods with pre-specified acceptance criteria, and update procedures including labelling and communication to users), and Impact Assessment (individual and cumulative benefits, risks and mitigations). Changes are expected to be implemented under the quality management system of the manufacturer, in line with standards such as IEC 62304. It also discusses benefits and challenges, including more complex submissions and differing adoption across jurisdictions. The document aims to support international convergence and does not establish regulatory requirements or serve as regulation or guidance in any jurisdiction.
Published: 2026-08-06
MDSAP
MDSAP AU P0002.011
MDSAP Audit Approach (MDSAP AU P0002.011)
Revision 11 of the MDSAP Audit Approach (document number MDSAP AU P0002.011, revision date 3 August 2026), the audit procedure of the Medical Device Single Audit Program in which the regulatory authorities of the United States, Australia, Brazil, Canada and Japan participate. Main changes from version 010: (1) Cybersecurity. Measurement, Analysis and Improvement Task 12 adds provisions on post-market feedback, including systematic collection of vulnerability reports, security incident data and threat intelligence, used as input to risk management, improvement and design change control. Design and Development Tasks 7 and 12 add US FDA cybersecurity requirements, and Task 7 adds RDC ANVISA 848/2024 Article 1 to the Brazilian requirements. For the FDA, auditors verify that cyber devices cleared or approved after 29 March 2023 meet section 524B(b) of the FD&C Act: a plan to monitor and address post-market vulnerabilities including coordinated vulnerability disclosure, processes and post-market patches to keep the device cybersecure, and a maintained software bill of materials. (2) The predetermined change control plan (PCCP) text in Device Marketing Authorization and Facility Registration Task 3 no longer refers specifically to AI-enabled devices. (3) Other changes include refocusing Management Task 7 on management oversight of risk management across the product life cycle, and additions on UDI for Australia (TGA) and the FDA.
Published: 2026-08-03
EU
Law
Law
Regulation (EU) 2026/1744
Regulation (EU) 2026/1744 amending Regulations (EU) 2024/1689, (EU) 2018/1139 and (EU) 2023/1230 as regards the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI)
Regulation simplifying the implementation of the harmonised rules on artificial intelligence (Digital Omnibus on AI). It amends the AI Act (Regulation (EU) 2024/1689) together with Regulations (EU) 2018/1139 and (EU) 2023/1230. Dated 8 July 2026 and published in the Official Journal on 24 July 2026, it enters into force on the third day following publication. The date of application of Sections 1 to 3 of Chapter III of the AI Act is set to 2 December 2027 for AI systems classified as high-risk under Article 6(2) and Annex III, and to 2 August 2028 for those classified as high-risk under Article 6(1) and Annex I, which covers AI embedded in products such as medical devices.
Published: 2026-07-24
MHLW
Notice
Notice
MHLW-PFSB-MDED-0615-No.1
Pilot Implementation of Prioritized Review and Other Measures for Software as a Medical Device and Related Products (MHLW Notice No. 0615-1, June 15, 2026)
MHLW notice continuing the pilot of prioritized review for software as a medical device (SaMD), conducted since FY2022 following a June 2022 Cabinet decision on the New Capitalism action plan, by setting designation requirements and accepting applications on a rolling basis. Eligible products are SaMD and physical medical devices with SaMD-equivalent program functions; products seeking approval under the rebalancing notice or the two-stage approval notice are excluded. All three requirements must be met: (1) innovativeness of the treatment, diagnostic or preventive method (programs that deliver content equivalent to clinical patient guidance to prompt behavior change at home are, in principle, not considered innovative); (2) medical usefulness for the target disease; and (3) intent and capability to file in Japan first or simultaneously (within three months), using the PMDA SAKIGAKE comprehensive evaluation consultation. Designated products receive priority consultation, priority review under Article 23-2-5, paragraph 10 of the PMD Act, coordination by a concierge, and eligibility for the support program for consultation and applications for innovative medical devices, with the aim of shortening the review period to six months or less after adequate pre-submission evaluation. The procedure runs from registration, hearing and preliminary screening to formal application and PMDA evaluation, with results reported to the Pharmaceutical Affairs Council and then published. Conditions for revoking designation are also specified.
Published: 2026-06-15
FDA
CDRH
CDRH
fda_20260528_human_factors
Content of Human Factors Information in Medical Device Marketing Submissions
Final guidance issued by FDA CDRH on May 29, 2026 (finalizing the December 2022 draft) that provides a risk-based framework for the human factors information to include in 510(k), De Novo, PMA and HDE submissions; combination products are not addressed. Submitters determine one HF Submission Category per submission using a flowchart based on the use-related risk analysis (URRA): whether the device is a modification; whether the user interface, intended users, uses, use environments, training or labeling change; whether there are critical tasks (new or impacted, for modified devices); and whether human factors validation data are needed given the user interface history of use, its complexity and the adequacy of existing risk controls. Category 1 calls for a conclusion and high-level summary; Category 2 adds a rationale and descriptions of users, uses, environments, training, the user interface and known use problems; Category 3 calls for a full HFE/UE report including the URRA, critical tasks and human factors validation testing. Worked examples are included; for instance, a change to a computer-assisted detection algorithm with no user interface change falls into Category 1. The guidance is a companion to Applying Human Factors and Usability Engineering to Medical Devices. FDA generally does not anticipate the newly recommended information in submissions pending at publication or received before August 1, 2026. Docket FDA-2015-D-4599.
Published: 2026-05-29
EU
MDCG
MDCG
Borderline Manual
Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5
Version 5 (April 2026) of the manual recording agreements reached by the competent authorities of the Member State members of the Borderline and Classification Working Group (BCWG), a subgroup of the MDCG, through the Helsinki Procedure under the MDR and IVDR. It presents the background and outcome of cases on qualification (borderlines between medical devices or IVDs and medicinal products, biocides, cosmetics, personal protective equipment and other products) and on the application of classification rules. Software-related cases include a smartphone application for STI prevention strategies (information exchange between users and a behaviour-based risk calculator do not constitute a medical purpose, so it is not a medical device) and medical calculators (calculating scores such as CHA2DS2-VASc goes beyond simple search, so the product is a medical device, classified at least class IIa under Rule 11). Cases added in Version 5 include packaging for administering a medicinal product, a penis holster, a syringe containing glass beads, needles for root canal irrigation and saline solutions for nasal irrigation. The manual is to be read with MDCG 2019-11 (software qualification and classification), MDCG 2021-24, MDCG 2022-5 and other guidance. It is not legally binding, does not reflect the official position of the European Commission, and decisions on individual products remain with national competent authorities.
Published: 2026-04-22