Non-Recognized Standards: Medical Devices

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".

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 The Edition 2.0 standard is withdrawn by IEC and is no longer published.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).