Changes to  FDA recognized consensus standards this year may catch many medical device manufacturers off-guard when preparing their medical devices for clearance or approval. The transition period for the 60601 series consensus standards listed below ends on December 17, 2023.  After this date, the FDA will no longer accept declarations of conformity to the older versions.  Some of the changes in these standards involve new tests, changes to expectations for risk management, and changes to documentation.  

New versions: 

• ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) [Including Amendment 2 (2021)]  
• IEC 60601-1-2 Edition 4.1 2020-09  
• ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] 
• IEC 60601-1-3 Edition 2.2 2021-01  
• IEC 60601-1-6 Edition 3.2 2020-07  
• IEC 60601-1-8 Edition 2.2 2020-07  
• ANSI AAMI IEC 60601-1-8:2006 and A1:2012 [Including AMD 2:2021] 
• IEC 60601-1-10 Edition 1.2 2020-07  
• IEC 60601-1-11 Edition 2.1 2020-07  
• ANSI/AAMI HA60601-1-11:2015 [Including AMD1:2021]  
• IEC 60601-1-12 Edition 1.1 2020-07  
• ANSI AAMI IEC 60601-1-12:2016 [Including AMD 1:2021] 

Old versions that will no longer be accepted: 

• ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012   
• IEC 60601-1-2 Edition 4.0 2014-02  
• ANSI AAMI IEC 60601-1-2:2014 
• IEC 60601-1-3 Edition 2.1 2013-04 
• IEC 60601-1-6 Edition 3.1 2013-10  
• IEC 60601-1-8 Edition 2.1 2012-11  
• ANSI AAMI IEC 60601-1-8:2006 and A1:2012 
• IEC 60601-1-10 Edition 1.1 2013-11  
• IEC 60601-1-11 Edition 2.0 2015-01  
• ANSI/AAMI HA60601-11:2015  
• IEC 60601-1-12 Edition 1.0 2014-06  
• ANSI AAMI IEC 60601-1-12:2016  

As you develop your compliance plan ensure you are designing and testing to the most recent standard version the FDA will accept at the time of your submission.  Also, pay attention to updated FDA guidance documents.  In some cases, the standard updates are very advantageous as the updated IEC 60601-1-2 Electromagnetic Disturbances (EMC) standard now more closely aligns with the recent FDA Guidance (see our other post, New FDA EMC Guidance – CMD MedTech).  Talk to one of our Compliance Engineers to assess potential gaps and plan appropriately to reduce the risks of FDA rejections and product launch delays.   

In June of 2022 the FDA issued an updated guidance for “Electromagnetic Compatibility (EMC) of Medical Devices”.  This guidance offers significantly more detail than the 2016 guidance as it describes the relevant information that should be considered and provided in an FDA submission to support a claim of electromagnetic compatibility (EMC) for medical devices and in vitro diagnostic devices (IVDs). 

Key areas of focus and additions: 

• Intended Use Environments 
• EMC risk assessments (ISO 14971) 
• Risk Considerations that may not be adequately covered in existing consensus standards due to technology evolution (i.e. 5G, MRI, NFC, WPT) 
• Applicable consensus standards and considerations in addition to or in lieu of IEC 60601-1-2 
• Immunity acceptance criteria and Essential Performance 
• Labeling for EMC 
• Leveraging existing EMC results vs new EMC testing 
• Emitters – specifically RFID: Now includes consideration of AIM 7351731 RFID immunity standard ”or” IEC 60601-1-2:2020 Clause 8.11 (61000-4-39) ”or” equivalent methods with justification 
• Recommended that Investigation Device Exemptions (IDE) and Investigational New Drug (IND) submissions also consider this guidance 

While the guidance helps clarify at a high level the expectations and considerations, the selection of the appropriate standards, test method implementation, and acceptance criteria are the manufacturer’s responsibility as they are specific to each product and intended use.   Many of the expectations of the guidance are typically addressed in the risk management file as well as an adequate EMC test plan and test report. 

An EMC test plan, created by the manufacturer and reviewed and aligned with by the test lab, at minimum should clearly capture Essential Performance and acceptance criteria, how performance is observed, description of the intended use and use environment, tests and test levels, deviations and special equipment used.  Additionally, it documents the test configurations including connections, voltages and frequencies, software, and modes of operation.  To fully test with respect to potential EMC risks multiple modes of operation or configurations may need to be evaluated.    

For any questions or assistance with compliance of your product please contact us using our contact page.

To see the FDA guidance please visit Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices. 

The FDA has identified a list of Class I and Class II medical devices that are exempt from 510(k) and Good Manufacturing Practices (GMP) requirements, “subject to certain limitations.”  If a device is exempt from 510(k) submission requirements, it may also be exempt from GMP requirements (but not the other way around).  What do these two different scenarios mean for your organization and products?

Although FDA’s 510(k) program is the most commonly used device review pathway for medical devices in the US, not all devices need a formal submission to be legally marketed. Some medical devices are exempt from 510(k) clearance, meaning that manufacturers can market their device without clearance from the FDA. In addition, some of these exempt devices are also exempt from GMP requirements. What does this all mean? And is it going to save your company time and money?

You can determine whether a particular device is exempt from these requirements by searching the FDA’s Product Classification database.

In the following example, this product code is exempt from the 510(k) process, but still requires conformance to Good Manufacturing Practices:

Some Class I and Class II devices are exempt from both the 510(k) process and GMP requirements (with some limitations). Others are just exempt from 510(k), but not GMP. Let’s explore each of these cases further:

510(k) Exempt Only (but not GMP exempt)

Most Class I devices and some Class II devices fall into this category. What does this mean?

• FDA still expects that the Quality System Regulation (also referred to as GMP, cGMP, Good Manufacturing Practices, QSR or 21 CFR 820) is followed even though a 510(k) (premarket notification) submission is not required.
• These devices still require the implementation and use of a QSR-compliant quality system.
• You will still need to register your establishment and list your product(s) with the FDA

Our customers often ask “Do I need to follow all of the standards and guidance documents if I’m not submitting a 510(k)?” In general, the answer should be “yes.” Although FDA guidance and recognized standards aren’t a legal requirement, they represent FDA’s idea of safe and effective products. In addition, standards and guidances typically represent good engineering and quality practices and will result in a better device.  Lastly, a lack of adherence could lead to a finding in an audit or result in a device that causes harm.

510K Exempt and GMP Exempt

Some Class I devices fall into this category:

• Products in this category are exempt from the GMP/QSR regulation, except for the requirements for maintaining records (21 CFR 820.180) and complaint files (21 CFR 820.198)
• Use caution: devices are not exempt from GMP if the device labeled or otherwise represented as sterile, or if the device contains software.
• You will still need to register your establishment and list your products with the FDA.

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CMD can help your company strategize on the regulatory classification path of your device, including supporting discussions with the FDA and ensuring that time and effort is not spent complying with unnecessary regulations.