FDA’s final “Classification of Accessories Distinct from Other Devices; Finalized List of Accessories Suitable for Class” will be posted shortly at https://www.federalregister.gov/documents/2019/04/12/2019-07290/medical-devices-classification-of-accessories-distinct-from-other-devices-finalized-list-of.
While this allows for certain accessories for higher class devices to be exempt from premarket notifications, the preamble has a section worth noting as a reminder for medical devices containing software. The preamble states:
“Note that by regulation, design controls apply to class I devices only if the devices are automated with computer software or are listed under § 820.30(a)(2)(ii) (21 CFR 820.30(a)(2)(ii)). Thus, if an accessory is not automated with computer software but would require design controls to provide reasonable assurance of safety and effectiveness, we did not consider it eligible for this classification process.”
When the Quality System regulation was issued, it was a surprise to some that, technically, if software was in a device then there would be no exemption from Design Controls for the device overall regardless of the role of software in the device. While this is not new, it is worth remembering when referencing Class I devices and regulatory requirements associated with them.
See our earlier post on accessories at FDA Device Accessories Classification Guidance.