FDA Guidance on Medical Device Accessories updated
Here is a quick follow-up of the new version of the FDA Guidance titled Medical Device Accessories – Describing Accessories and Classification Pathways, published in December 2017. This comes a bit in parallel to the Section 3060 guidance described in the previous post on the 21st Century Cures Act.
The previous version of this guidance had been published in January 2017.
First remark, the FDA didn't include the changes of the accessories guidance in the Section 3060 guidance. This is understandable, as the final version of the accessories guidance had been published in January 2017 after the 21st Century Cures Act.
Second remark, the major update of the accessories guidance is the addition of a new section on Accessory Classification Process. Its stems from the FDA Reauthorization Act of August 2017, posterior to the 21st Century Cures Act. We find in this section the provisions of the section 707 of the Reauthorization Act about accessories.
One tiny change in the text of the guidance is the inclusion of optional articles in the definition of accessory.
An article intended to be used with a parent medical device and labelled as optional is an accessory.
Accessory classification process
The main change is the addition of the section named "Accessory Classification Process".
It makes the distinction between:
- New accessory types,
- Existing accessory types;
- New accessory types through the De Novo process.
The purpose of the section is to explain how to request the FDA to classify an accessory parent of a device when the device is submitted in a 510k, a PMA or a De Novo process. The guidance clarifies the possibilities to put accessories in a class different from the parent device, with a risk-based approach.
Software As a Medical Device (SaMD) accessories
For Software As a Medical Device (SaMD), this guidance doesn't change much of the regulatory landscape. The recommendations of the guidance don't change about what kind of software should be deemed an accessory.
The following sentence, present in the version of January 2017 of the guidance, remains in this new version:
FDA intends for the risk- and regulatory control-based classification paradigm discussed in this guidance to apply to all software products that meet the definition of an accessory, including those that may also meet the definition of Software as a Medical Device (SaMD).
We now know with this new version of the guidance that we have these options to classify a SaMD, which comes as an accessory to a medical device, in a class different from the parent device.