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.

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