What kind of medical devices are applicable tothe 6Guidance for premarket review for medical devicescybersecurity*? Can the cybersecurity descriptiondocument be submitted within the software descriptiondocument?
1 回答
The“Guidance for premarket review for medical devicescybersecurity”is applicable to the registration and applicationof Class I and Class Il medical device products with networkconnection function for electronic data exchange or remote controland storage medium for electronic data exchange.
The cybersecurity description document is independent of thesoftware description document and shall be submitted separately.
