Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff

Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders

labeling for a Bowie Dick Test Pack should contain specific statements

Premarket Notification [510(k)] Submissions for Chemical Indicators

System that reveals change in process variables based on chemical or physical change

Intended to distinguish between processed and unprocessed units.; type of chemical indicator requiring characterization via resistometer results

Designed to react to all critical parameters over a specified range of sterilization cycles.; monitors all critical parameters of a sterilization cycle

Used in test packs to determine the efficacy of the air removal phase in steam sterilization.; performance criteria and endpoint specifications inside a test pack

FDA intends to assess device cybersecurity based on a number of factors; demonstrate or maintain its safety and effectiveness; ensuring cybersecurity has become essential to FDA’s ability to protect the public health; Cyber-resiliency capabilities for medical devices

Microbiological test system providing a defined resistance to a specified sterilization process; Guidance for premarket notification submissions of BIs; Subject of the premarket notification 510(k) submission

intended to create a challenge to the sterilization process