Table 2.

US Food and Drug Administration and European classification for in vitro diagnostic medical devices

US FDA	Regulation (EU) 2017/746
Class III	Class D
Highest risk	High risk of infection or specific blood groupings
General controls	Manufacturer performs tests on each manufactured batch of devices
PMA	Expert panel/EU reference laboratory evaluates the manufacturer performance evaluation report
Clinical studies needed^	Class C
Class II	Detection of nonhigh risk infectious agents, managing life-threatening disease or condition, companion diagnostics
Moderate risk
General controls and special controls	Class D and C require
Premarket notification 510(k)	Notified body conformity assessment*
Substantial equivalence to a predicate	EU type-examination certificate
	Quality management system assessment
	Safety and performance evaluation document should be publicly available, updated at least annually
	Clinical studies needed^
	Synergies with EU database for clinical trials on medicinal product
	Postmarket surveillance: PSUR at least annually
-	Class B
	Many self-testing devices (glucose, erythrocytes, leucocytes, and bacteria in urine)
	Notified body conformity assessment*
Class I	Class A
Low risk	General laboratory products
General controls (GMP)	Manufacturer conformity assessment
510(k) exempt
Registration and listing

^{^}Clinical studies are needed. The study must demonstrate that clinical interpretations (diagnoses) made based on the digital pathology images are comparable to those made using glass slides. In case technological characteristics are modified, clinical studies are not needed if substantial equivalence to the previous version can be demonstrated with attributes such as the intended use/indications for use, technology and design features, and safety and effectiveness, *When the device clinical performance which cannot be fully determined by analytical performance studies, literature, and/or previous experience gained by routine diagnostic testing, clinical performance studies are necessary to demonstrate compliance with the relevant general safety and performance requirements. GMP: Good manufacturing practices, PMA: Premarket approval, PSUR: Periodic safety update report, EU: European Union, FDA: Food and Drug Administration