• According to the FD&C Act, the US FDA continuously collects market updates and adopts recommendations to modify the classification policy in order to match the market and technology requirement. In this context, the US FDA received the De Novo Classification request for re-classification of two types of devices, namely, Intravascular Bleed Monitors [1] and Non-Implanted Electrical Stimulation Devices (for Management of Premature Ejaculation) [2].

As a result, and starting from June 2022, a new order for the classification modification of both types of devices has become effective, which classifies them as Class II instead of Class III products.  

The Intravascular Bleed Monitor:
In summary, FDA has identified the risks in the following table below (table 1), and provides suggestions mitigating for these risks concerning the Intravascular Bleed Monitor:

Table 1: FDA summarizes the Intravascular Bleed Monitor Risks and Mitigation Measures [1]

Identified Risks	Mitigation Measures
Adverse tissue reaction	Biocompatibility evaluation.
Infection	Sterilization validation, Pyrogenicity testing, Shelf-life testing, and Labeling.
Blood loss, bleeding, hematoma	Human factors testing, Labeling, Animal performance testing, and Non-clinical performance testing.
Embolization (micro or macro) with transient or permanent ischemia	Human factors testing, Labeling, Animal performance testing, and Non-clinical performance testing.
Vascular trauma ( i.e., dissection, rupture, perforation, tear, etc.)	Human factors testing, Labeling, Animal performance testing, and Non-clinical performance testing.
Electrical shock	Electrical safety testing.
Device failure due to interference with other devices	Electromagnetic compatibility (EMC) testing, and Electrical safety testing.
Device failure due to software malfunction	Software verification, validation, and hazard analysis.

For further detailed information, please kindly proceed by searching the Regulation Number 870.1345 in order to see the complete FDA requirements for the device [3].

Non-Implanted Electrical Stimulation Device for Management of Premature Ejaculation:
FDA has likewise identified the risks in the following table below (table 2), and provides suggestions mitigating for these risks of the Non-Implanted Electrical Stimulation Device for Management of Premature Ejaculation:

Table 2: FDA summarizes the Non-Implanted Electrical Stimulation Device for Management of Premature Ejaculation Risks and Mitigation Measures [2]

Identified Risks	Mitigation Measures
Use error leading to patient pain, discomfort, or injury	Labeling.
Electrical, mechanical, or thermal fault, system malfunction, or other device failure resulting in lack of treatment or patient discomfort/injury ( e.g., electrical shock, burn, tissue damage, or interference from other medical devices or electrical equipment)	Non-clinical performance testing; Electrical safety testing; Electromagnetic compatibility testing; Software validation, verification, and hazard analysis; Shelf-life testing; and Labeling.
Adverse tissue reaction	Biocompatibility evaluation, and Labeling.

For more comprehensive information, please feel free to search the Regulation Number 876.5026 to be able to see the complete FDA requirements for the device [4].

By means of the new classification and the mitigation measures introduced, FDA is effectively working on addressing any risks to health, and to provide reasonable assurance of safety and effectiveness to be able to provide the best benefit for each user. The necessary special controls appear in the regulation codified by these orders and the devices are now subject to premarket notification requirements under section 510(k).
 

References:

1. Medical Devices; Cardiovascular Devices; Classification of the Intravascular Bleed Monitor
2. Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Implanted Electrical Stimulation Device for Management of Premature Ejaculation
3. § 870.1345 Intravascular bleed monitor
4. § 876.5026 Non-implanted electrical stimulation device for management of premature ejaculation