|
Standards Developing Organization
|
Standard Designation Number and Date
|
Title of Standard
|
Summary of Rationale for Non-Recognition
|
ISO |
20916 First edition 2019-05 |
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice |
This ISO standard creates two general buckets of clinical performance studies with different expectations for ethical conduct/IRB review: interventional (e.g., data used for patient 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.
|
JIS |
H4650:2016 |
Titanium and titanium alloys -- Bars |
The standard include many grades of titanium and titanium alloy for purposes other than medical devices. Recognition limited to Grade 2 titanium is also 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.
|
ISO |
15197 Second edition 2013-05-15 |
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus |
"The criteria set forth in the ISO 15197 standard are not sufficient to adequately protect lay-users using SMBGs because, for example, the standard does 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".
|
IEC |
61326-1 Edition 2.0 2012-07 |
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements |
Based upon the scope and the approach to testing, IEC 61326-1 describes test planning, including acceptance criteria and a specification of functional performance, immunity 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.
|
ISO |
16840-10 First edition 2014-12-15 |
Wheelchairs - Resistance to ignition of non-integrated seat and back support cushions- Part 10: Requirements and test methods |
The standard measures only the resistance to ignition of the items tested and not the ignitability of the complete integrated wheelchair seating. It gives 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).
|