The FDA released a new final guidance yesterday titled “Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements.” A total of 13 product codes across 8 FDA review divisions were listed in the guidance that will be exempt from 510(k) clearance requirements.
However, the FDA stated that it does not intend to propose exempting these devices from other statutory and regulatory requirements, including, but not limited to:
- registration and listing (21 CFR part 807);
- labeling (21 CFR part 801);
- good manufacturing practice requirements as set forth in the Quality Management System Regulation (21 CFR part 820);
- and Medical Device Reporting (21 CFR part 803).
It was not the FDA’s intent to propose exempting from premarket notification requirements any combination products, including single-entity products containing an antimicrobial agent, that may fall within the product codes listed in this guidance.
It is worth noting that the guidance stated it is being implemented immediately, without prior public comment, because FDA has determined that prior public participation for this guidance is not feasible or appropriate and that FDA has determined that this guidance document presents a less burdensome policy that is consistent with public health.
Few, if any, could find issue with moving these product codes to 510(k) exempt status and it certainly seemed the reasonable thing to do based on the risks presented by the listed devices. But the timing of this guidance release is interesting, as this guidance last saw an update nearly seven years ago. It remains to be seen if this signals a new future trend, where the FDA will suddenly convert other 510(k) clearance required product codes to 510(k) exempt. If that does come to pass, it would be well received by industry and could reduce work load on the already taxed FDA review teams at CDRH.
