Non-Recognized Standards: Medical Devices

requirements, emissions requirements, and test results/reporting that together confer less expectation of predictability than the FDA-recognized ES60601-1 and IEC 60601-1-2 standards or provides only part of a complete immunity test for medical device products. It does not adequately test all the attributes that FDA would consider necessary to evaluate the performance for medical devices and medical products that contain sensitive circuitry and electronics, for example. For these reasons, FDA considers IEC 61326-1 methodology not robust enough for FDA to rely upon a declaration of conformity (DoC) that would establish or predict the performance of medical devices when subjected to electrostatic discharge, electromagnetic fields, power frequency magnetic field, and (electrical fast transients) burst.

FDA has recommendations for manufacturers in their Guidance titled:"Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices" published on July 11, 2016.Section II. EMC Information provides what information a claim of EMC for a device should demonstrate to facilitate premarket submissions and reviews. IEC 61326-1 may still be fit for its purpose to support the performance of a device subject to a premarket submission to FDA, with proper justification, and this would be dependent upon a risk assessment for the type of medical device under consideration. This use would fall under Section IV.B.,"General Use of Consensus Standards" as explained in our guidance. Please refer to Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, issued 2018.

not adequately address the performance of over-the-counter blood glucose test systems in the hypoglycemic range (low blood glucose readings range) or across test strip lots."

See Section VI.Performance Evaluation for SMBGs of "Guidance for Industry and Food and Drug Administration Staff: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use; Issued Sept. 2020".

care) and non-interventional (e.g., leftover specimens or archived specimens). Under this ISO standard, it is only for interventional studies that the standard specifies a requirement for IRB/Ethics committee approval, while there are no similar requirements for non-interventional studies. This is inconsistent with FDA's regulations which includes requirements for informed consent and Institutional Review Board (IRB) review that apply to all clinical investigations of devices involving human subjects, including de-identified or leftover specimens.

In addition to this ISO standard not satisfying the FDA requirements for data from clinical investigations from in vitro diagnostics, the term "clinical performance study" used in the ISO document is not consistent with FDA's thinking regarding different types of "IVD clinical studies" which include i) "IVD clinical outcome studies" which are "interventional" and ii) "IVD clinical performance studies" which can be either "interventional" or "non-interventional". This confusion of concepts in the ISO document was a subject for the FDA comments provided to the ISO in 2017-2018.

For the reasons described above, this ISO document is not in conformance with FDA requirements (see e.g.,21 CFR parts 50, 56, or 812). These inconsistencies in the above ISO standard have the potential to add to confusion, if recognized, and could negatively impact the ongoing efforts to ensure stakeholders adhere to FDA's Good Clinical Practice requirements and expectations for IVD studies, particularly those involving left-over specimens, in addition to not satisfying FDA requirements.

requirements, emissions requirements, and test results/reporting that together confer less expectation of predictability than the FDA-recognized IEC 60601-1-2 standard or provides only part of a complete immunity test for medical device products. It does not adequately test all the attributes that FDA would consider necessary to evaluate the performance for medical devices and medical products that contain sensitive circuitry and electronics, for example. For these reasons, FDA considers the IEC 61326-2-6 methodology not robust enough for FDA to rely upon a declaration of conformity (DoC) that would establish or predict the performance of medical devices when subjected to electrostatic discharge, electromagnetic fields, power frequency magnetic field, and (electrical fast transients) burst.

FDA has recommendations for manufacturers in their Guidance titled:"Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices", published on July 11, 2016. Section II. EMC Information provides what information a claim of EMC for a device should demonstrate to facilitate premarket submissions and reviews. IEC 61326-2-6 may still be fit for its purpose to support the performance of a device subject to a premarket submission to FDA, with proper justification, and this would be dependent upon a risk assessment for the type of medical device under consideration. This use would fall under Section IV.B.,"General Use of Consensus Standards" as explained in our guidance. Please refer to Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, issued 2018.

basic safety and essential performance (IEC 60601-1:2005, MOD). This standard is currently recognized under Rec#19-4.

UL 60601-1 First edition 2003 is based on an older version of IEC 60601-1, namely IEC 60601-1 Edition 2.0, as revised by Amendments 1 and 2. The Edition 2.0 standard is withdrawn by IEC and is no longer published. CDRH currently recognizes AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD), which is the U.S. deviation of IEC 60601-1 Edition 3.1. With rapid advancements in technology, medical devices are increasingly complex and the environment in which they are used is constantly evolving. CDRH uses a risk-based regulatory framework that relies on the principles of risk assessment and risk management.The risk analysis found in IEC 60601-1 Edition 3.1 allows CDRH to take into consideration the intended use and environment of use in determining the electrical safety of medical devices. This flexibility is absent in the standard you have proposed for recognition. IEC 60601-1 Edition 3.1 is accepted and widely used. Collateral and particular standards within the IEC 60601 series are either already aligned or are in the process of aligning with the parent standard. Therefore, recognition of UL 60601-1:2003 could potentially create unnecessary confusion, duplication of effort, and inconsistency in terms of basic safety and performance testing, and has the potential to hamper global harmonization efforts