{"id":8406,"date":"2026-01-04T11:15:53","date_gmt":"2026-01-04T11:15:53","guid":{"rendered":"https:\/\/eisnersafety.com\/?p=8406"},"modified":"2026-01-04T23:38:48","modified_gmt":"2026-01-04T23:38:48","slug":"dec-22-2025-fda-updated-its-recognized-consensus-standards-db-100-new-or-updated-standards","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2026\/01\/04\/dec-22-2025-fda-updated-its-recognized-consensus-standards-db-100-new-or-updated-standards\/","title":{"rendered":"Dec 22, 2025: FDA Updated Its Recognized Consensus Standards db 100+ New Or Updated Standards"},"content":{"rendered":"\n

FDA Updated Its Recognized Consensus Standards db<\/h1>\n\n\"FDA\n\n

Key themes: IEC 60601\/80601, IEC 61326-2-6, ISO 15223-1 A1:25, & ASCA considerations<\/strong><\/h3>\n\n

\nIn late December 2025, the FDA expanded its Recognized Consensus Standards Database, adding more than 100 new or updated standards. Some are eligible for use under the ASCA Program, while others carry important implications for design, testing, labeling, and overall regulatory strategy.\n<\/p>\n\n

\nRegulatory expectations around standards are shifting earlier in the product lifecycle. Standards are no longer something teams can simply \u201chandle at test.\u201d Reviewers increasingly expect standards interpretation, risk decisions, and test strategies to be visible and justified during design reviews and technical documentation development. This reinforces why understanding not just which standards are recognized, but how they are recognized and applied, matters more than ever.\n<\/p>\n\n

What the latest FDA update included<\/strong><\/h3>\n\n

\nThe scope of this database expansion spans a wide range of medical device technologies, including medical electrical equipment, IVDs, software-driven devices, imaging systems, interoperability standards, and labeling-related standards.\n<\/p>\n\n

\nBeyond simply identifying newly recognized standards, the changes highlight how recognition status<\/strong>, ASCA eligibility<\/strong>, and extent of recognition<\/strong> can materially affect how conformity is demonstrated, how evidence is presented, and how submissions are reviewed.\n<\/p>\n\n

\nOver the past year, I\u2019ve been sharing what I\u2019m seeing based on feedback gathered from many sources, including my Eisner Safety Consultants experts and discussions across the community with regulators, standards developers, test labs, and manufacturers. The goal is practical clarity: what changed, what it means, and what teams should do next as they navigate evolving standards expectations and regulatory requirements.\n<\/p>\n\n

\n\n

IEC 60601 \/ 80601 standards in the update<\/h2>\n\n

\nFor manufacturers of medical electrical equipment, the December 22, 2025 update includes\nseveral standards from the IEC 60601 and 80601 series.<\/strong>\nThese standards remain central to demonstrating basic safety and essential performance\nfor medical electrical equipment. However, recognition alone does not mean every clause\nor requirement is fully accepted without qualification.\n<\/p>\n\n

Standards called out in the December 22, 2025 update
\n(from the FDA database extract)<\/small><\/h3>\n\n\n
\n \n \n \n \n \n \n \n \n
\n Standard\n <\/th>\n \n Title (abbreviated)\n <\/th>\n \n FDA Recognition No.\n <\/th>\n \n Extent of Recognition\n <\/th>\n <\/tr>\n <\/thead>\n\n
IEC 80601-2-70:2025<\/strong><\/td>\n Sleep apnoea breathing therapy equipment<\/td>\n 1-199<\/td>\n Complete<\/strong><\/td>\n <\/tr>\n\n
IEC 60601-2-31:2020<\/strong><\/td>\n External cardiac pacemakers<\/td>\n 3-201<\/td>\n Complete<\/strong><\/td>\n <\/tr>\n\n
IEC 60601-2-34:2024<\/strong><\/td>\n Invasive blood pressure monitoring<\/td>\n 3-202<\/td>\n Complete<\/strong><\/td>\n <\/tr>\n\n
IEC 80601-2-49:2024<\/strong><\/td>\n Multifunction patient monitoring equipment<\/td>\n 3-203<\/td>\n Partial*<\/strong><\/td>\n <\/tr>\n <\/tbody>\n <\/table>\n<\/div>\n\n\n
\n

\n * Partial recognition. The following part(s) of the standard is (are) not recognized:<\/strong>
\n Subclause 202.8.101 “IMMUNITY test setup” – Reference to table height (>= 0,4 m) for IMMUNITY testing in Figure 202.101.
\n Refer to Rationale for Recognition for explanation of partial recognition.<\/strong>\n <\/p>\n<\/div>\n\n\n\n

EMC context within the IEC 60601 \/ 80601 framework<\/h3>\n\n

\nIEC 60601-1-2 remains the primary EMC standard within the IEC 60601 series.\nHowever, other IEC 60601 standards can and do include EMC-related requirements.\nApplicability must be assessed standard by standard, based on the specific requirements\nof each applicable document.\n<\/p>\n\n

\nThis context becomes especially important when considering how EMC expectations are\naddressed across different standard families, including IVD-specific EMC requirements\ndiscussed next.\n<\/p>\n\n

\n\n

IVD EMC and IEC 61326-2-6<\/h2>\n\n

\nA notable change reflected in the FDA Recognized Consensus Standards Database is the\ninclusion of IEC 61326-2-6 Edition 4 as a Recognized Consensus Standard<\/strong>,\nwith ASCA eligibility under the ASCA Program, effective July 28, 2025.\n<\/p>\n\n

\nThis is significant because IEC 61326-2-6 is the primary EMC standard used to\ndemonstrate electromagnetic compatibility for IVD medical equipment<\/strong>, and its\ninclusion under ASCA directly affects how EMC conformity evidence may be presented in FDA\nsubmissions.\n<\/p>\n\n

However, ASCA eligibility alone does not guarantee streamlined review.<\/strong><\/p>\n\n

For manufacturers intending to rely on ASCA pathways for IVD EMC:<\/p>\n\n