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 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.

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