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.

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

an indication, but cannot guarantee, the ignition behavior of the assembled integrated devices of a complete wheelchair. The standard states: Where practical, it is advisable that manufacturers use materials with superior resistance to ignition. The manufacturer is required to make the case as to why ISO 7176-16 Wheelchairs-Part 16: Resistance to ignition of postural support devices, could not be employed rather than this part of ISO 16840. Currently FDA recognizes wheelchair standards such as: ISO 7176-16, RESNA WC-1 and WC-2. These standards are used to satisfy premarket performance requirements for all types of wheelchairs. These standards have been accepted to demonstrate substantial equivalence (SE),safety and effectiveness of wheelchairs. The current FDA recognized wheelchair standards series is well understood and for this reason, lend themselves to a Declaration of Conformity (DoC).

In addition, we note that the scope of ISO 16840-10 First edition 2014-12-15 conflicts with ISO TR 13570-1 First edition 2005-04-15 Wheelchairs- Part 1: Guidelines for the application of the ISO 7176 series on wheelchairs , Clause 6.2.3.3 Interpretation of results - Flammability. The clause states in part: Cushions and supports added after purchase may not have been subjected to the flammability test. If you are a smoker or you spend time with people who smoke, then you should choose a wheelchair that passes this test. Because ISO 16840‐10 does not include flammability testing of all the integrated wheelchair "soft" surfaces or upholstered parts, as does the currently recognized ISO 7176-16 and RESNA WC-1:16, value is not added to the review towards a determination of substantial equivalence (SE).