So, you have a medical device that you are ready to put on the market? You’ve identified a product code and the device is Class I or II and 510(k) exempt. With no 510(k) submission required, you are ready to register and list with the FDA and start selling your product, right? Not so fast!

It is important to confirm your device’s 510(k) exemption status and any limitations that may apply before you start selling the device. The FDA’s Federal Food, Drug, and Cosmetic Act describes “certain limitations” that would require a 510(k) submission for a device that appears to be 510(k) exempt on the surface.

The 510(k) exemption is limited “only to those devices that have existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type”. If your device has unique characteristics and fits either of the following situations, the regulation says you are still required to submit a 510(k) prior to marketing:

1. The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;
2. The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology;

While not listed in this article, there are even more considerations for the limitations that impact in vitro diagnostic devices.

CMD can help you navigate this scenario by identifying your product’s exemptions and the limitations to those exemptions. For example, being 510(k) exempt does not guarantee that the device is also GMP (Good Manufacturing Practices) exempt. (More on other common exemptions can be found here.)

When trying to determine FDA medical device classification, there are a few ways to get information and feedback from the Agency. We are often asked how we choose between a Pre-Submission Request for Feedback (part of the Q-Submission Program) or a 513(g) Request for Information when determining medical device classification.  While both can provide valuable information, we have listed some of the distinctions of each below that help drive the decision.  We won’t call any of these “pros” or “cons” because it depends on the goals of our clients and the nuances of the particular medical device.

Clarity on Device Classification through a Pre-Submission (Pre-Sub):

• Nothing that the FDA or the company says is binding.
• You cannot directly ask for the classification of your device in a Pre-Sub but you may be able to ask similar questions that would give you insight on a classification. For example, you may propose a predicate device and then ask “Are there concerns with the predicate device proposed?”.  If no concerns are raised, this could be an indication the predicate could be used to prove substantial equivalence in a future 510(k) submission.
• There are no user fees for a Pre-Sub request.
• A Pre-Sub generally allows for 3-4 questions/topics.
• A Pre-Sub allows an opportunity for a teleconference or in person meeting.
• Response time for a Pre-Submission is 70 days (or 5 days prior to the scheduled meeting, if requested) and our recent Pre-Subs have all fallen within this time frame.
• After a Pre-Sub teleconference draft meeting minutes must be submitted to FDA as an amendment within 15 days.
• FDA may still suggest a 513(g) Request for Information.

513(g) Request for Information:

• While the decision is like a Pre-Sub and also non-binding, FDA will typically stay consistent with their proposed classification/response if there are no substantial changes later.
• If FDA gives you a product code/classification opinion for your device (assuming that one exists) you will have a potential path to market.
• There is a user fee associated with a 513(g) ($6,528 standard or $3,264 for small businesses* in fiscal year 2024).
• 513(g) requests do not offer the flexibility to ask questions on multiple topics or have any live dialog with FDA as the response is a written-only response.
• Response time for a 513(g) is intended to be within 60 days of receipt. (Important note: this timeline has not been met on any of our recent submissions).
• Requires draft labeling.
• FDA may still suggest a De Novo or PMA submission if a classification does not exist.

Both 513(g) and Pre-Submission requests have FDA-prescribed formats. CMD can help you balance the business and regulatory risk of these different pathways in addition to authoring the submissions and supporting the FDA interactions.

*Note that applying for “small business designation” with FDA requires 60 days to process and must be completed before you can leverage the small business pricing. Plan ahead!

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 Current Good Manufacturing Practices (GMP / cGMP) are followed, even though a 510(k) premarket notification submission is not required.
• You will still need to register your establishment and list your product(s) with the FDA

Most of these Class I devices do not require Design Controls (see device exceptions in 21 CFR 820.30). However, a Device Master Record (DMR) is required. We generally recommend that our customers try to conform to Design Controls, even if taking a “light touch,” because it provides additional assurance that the device is safe and effective, and allows fewer barriers to international market entry. We also recommend reviewing relevant standards and guidance for inclusion in the design process.

510K Exempt and GMP Exempt

Some Class I devices fall into this category:

• Products in this category are exempt from the GMP and 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.