On Decembre 30, 2019 the Food and Drug Administration (FDA) published a list of Class I and Class II medical devices exempted from the 510 (k) or Pre-Market Notification and subjected to certain restrictions detailed in the 21CFR 862.9-892.9.
Such measures should reduce the Regulatory constraints for the manufacturers of such medical devices and to eliminate the costs and submission expenses.
FDA has defined 5 types of Class II medical devices in the exemption from the Pre-market Notification:
- Accessory, Assisted Reproduction, product code MQG. The exemption is limited to the assisted production laminar flow workstation.
- Media, Reproductive, product code MQL. The exemption is limited to buffered saline solution with phosphate used for the washing and to handling and short – term manipulation of gametes and embryos, for crop oli used as overlay for breeding grounds containing gametes and embroys and to the water for assisted reproduction applications.
- Instruments Designed for Press-Fit Osteochondral Implants, product code QBO.
- System, Optical Position/Movement Recording (Interactive Rehabilitation Exercise Devices), product code LXJ. The exemption is limited to the use on medical prescription.
- Massager, Therapeutic, to Internally Massage Trigger Points in the Pelvic Floor. The exemption is limited to the use on prescription only of devices incorporating a quantitative feedback mechanism and a disposable cover for.
Furthrmore, continous glucous monitoring data management systems and digital systems have been attributed to Class I with related exemptions.
The decision is justified by the fact that these devices do not provide for a calculation about the pharmacological and theurapeutic administrations, but are limited to collecting data about the presence of glucous, useful to the subsequent therapeutic strategies processed by the medical staff. General controls were deemed sufficient to ensure the safety and efficacy of the devices.