Non-Recognized Standards: Medical Devices

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.

not possible because the test methods and requirements in this standard are in conflict with other recognized standards:
1) ASTM F67 Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
2) ISO 5832-2 Fourth edition 2018-03 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
JIS 4650 includes 19 normative references that are required to meet the JIS 4650, all of which are JIS documents and not generally available to those outside of Japan. This may present additional challenges to those who decide to use JIS 4650 outside of Japan and to make a direct comparison with other internationally harmonized standards.

Resource Book 2018: Guidelines for Selecting and Using ISTA Test Procedures and Projects; the rationale provided; and, current recognized packaging standards, namely, the ISTA 3 Series. The scope of the ISTA 2A standard and the ISTA Resource Book 2018 state, Test Procedure 2A is a partial simulation test for individual packaged-products. The test procedure is one of three tests offered by ISTA in Series 2: Partial Simulation Performance Tests. The method for 2A includes at least one element of 3 Series type General Simulation performance tests, such as atmospheric conditioning or mode-shaped random vibration, in addition to basic elements of a 1 Series type Non-Simulation Integrity test.

Based upon the scope and ISTA guideline for testing, Test Procedure 2A is characterized as a screening test that confers less expectation of predictability than the FDA-recognized ISTA 3 Series or provides only part of a complete simulation test for packaged products. It does not test all the attributes that CDRH would consider necessary to evaluate the performance for medical devices and medical products that would be packaged as sterile, devices that contain sensitive electronics, devices that contain liquids, or contain components known to be vulnerable to transportation and distribution stresses for example. For these reasons, FDA considers the Series 2A method 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 simulated distribution and transportation stressors.

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.

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.