FDA Medical Device Classification: Pre-Submission or 513(g)?

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!

60601 Series – FDA Transition Period Ending in 2023

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.   

New FDA EMC Guidance

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 visitInformation to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices. 

Are You Exempt from 510(k) and/or GMP?

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 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 Class I, GMP exempt 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.

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.

2019 Version of ISO 14971

The 3rd Edition of the Medical Device Risk Management standard, ISO 14971:2019, was approved May 2019 and replaces the second edition (ISO 14971:2007).

Key Changes Include:

  • Additional requirements of the Risk Management Plan.
  • Clarification to reasonably foreseeable misuse considerations.
  • Addition of a requirement for hazardous situations to be considered and documented.
  • Addition of a requirement for disclosure of residual risks.
  • Clarification to information collection requirements in production and post-production

For discussion on each of the changes, check out our full article.

Voice of the Customer

One of systems engineering’s core functions is to understand the user needs for a product or service, and seamlessly translate those needs into design requirements. We’ve helped our medical device customers do this for many years. A complete set of user needs is worth its weight in gold, as it minimized surprises during validation which may include product redesign!

Recently, we’ve begun “practicing what we preach,” to better understand our customers needs. Once we have fully vetted our customers’ needs (overlaid with the business and employee needs), they can be translated into our product and service offerings with a sound justification. My favorite process is still “Voices into Choices: Acting on the Voice of the Customer.” I used this process back in my days at Covidien (now Medtronic). It’s out of print, but available used for a few bucks. We’ve just started defining our objective statement and identifying our matrix of customers. We’ve identified some unique areas of exploration, even before speaking with our first customer.

We wrote a paper on using Voice of the Customer in medical device development. Check it out here.

Thoughts on Agile in Healthcare

IMG_0203

As noted in my previous blog post, I attended and presented at the INCOSE Conference on Agile in Healthcare last month. Here is my presentation. It was great to hear perspectives on being agile in healthcare product development, and discussing best practices with many thought leaders from major medical device manufacturers. I picked up two ideas that I’d like to investigate further and integrate into CMD’s processes as it makes sense.

First was the concept of agile practices in hardware development. While I don’t think a full-on scrum methodology makes sense for hardware (though it can be done with modified sprint cycles), I do appreciate the simplicity of a kanban-style backlog and project management process. In addition to kanban, I received some great insight on how to better integrate software and hardware development into sprint cycles.

Second, I’d like to investigate the SAFe agile framework further (P.S.: not an endorsement of SAFe). SAFe extends agile methodologies to the project and enterprise levels. A couple of medical device manufacturers with highly mature product development processes are using SAFe (or customized versions of it). It requires a good bit of tailoring to fit within a Quality Management System, but if done well, I think it has great potential for developing and maintaining a streamlined portfolio of safe and effective products.

Agile Product Development Presentation

Many medical device manufacturers and developers (including us) use agile principles to develop medical devices. Done properly, medical devices can be developed more efficiently while still meeting guidance, standards, and regulations. Unfortunately, many companies don’t do enough to ensure design controls are appropriately implemented when using agile during product development… whether it’s just for software, or the entire product development process. At the INCOSE Conference on Agile Systems in Healthcare on May 23 and 24, we’ll be presenting our direct experience with the FDA and medical device manufacturers. What does an inspector think of agile? How have medical device companies done it right (and wrong)? We’ll answer questions like this and have an open discussion on efficient, real-world implementation of agile in healthcare. Join us!

Hitting the Ground Running

We’ve kicked off company operations in March. It’s been a long time coming! One of our first tasks is to wrap up our Quality Management System (QMS). Lucky for us, ISO 13485:2016 has finally been published. I like the changes– they provide more detail around some critical activities like verification and validation, and ensure risk management is used throughout the QMS. ISO 13485 has begun its divergence from ISO 9001!

No notified bodies are certifying to the 2016 version at the moment, but we’re going to bake it into our QMS to ensure we’re ready to roll when the time comes. Along with conforming to ISO 13485 (2003 and 2016), we conform to 21 CFR 820 and the Canadian Medical Devices Regulations (SOR 98-282).

-Chad