RAC DEVICE FULL SOLUTION STUDY
PAPER 2026 QUESTIONS WITH ANSWERS
GRADED A+
●● Special 510(k). Answer: A type of 510(k) submission for device
modifications neither affecting the intended use nor altering its
fundamental scientific technology. FDA processing time is 30 days.
Requires Declaration of Conformity with design control
●● Abbreviated 510(k). Answer: A type of 510(k) submission supported
by conformance with guidance document(s), special controls or
standards.
●● Traditional PMA. Answer: The complete PMA application is
submitted to FDA at once.
●● Modular PMA. Answer: The complete contents of a PMA are broken
down into well-delineated components (or module) and each component
is submitted to FDA as soon as the applicant has completed the module,
compiling a complete PMA over time.
●● Streamlined PMA. Answer: A pilot program in the Division of
Clinical Laboratory Devices. A complete PMA is submitted as in a
traditional PMA; however, the Streamlined PMA is for a device in which
the technology and use are well known to FDA.
PAPER 2026 QUESTIONS WITH ANSWERS
GRADED A+
●● Special 510(k). Answer: A type of 510(k) submission for device
modifications neither affecting the intended use nor altering its
fundamental scientific technology. FDA processing time is 30 days.
Requires Declaration of Conformity with design control
●● Abbreviated 510(k). Answer: A type of 510(k) submission supported
by conformance with guidance document(s), special controls or
standards.
●● Traditional PMA. Answer: The complete PMA application is
submitted to FDA at once.
●● Modular PMA. Answer: The complete contents of a PMA are broken
down into well-delineated components (or module) and each component
is submitted to FDA as soon as the applicant has completed the module,
compiling a complete PMA over time.
●● Streamlined PMA. Answer: A pilot program in the Division of
Clinical Laboratory Devices. A complete PMA is submitted as in a
traditional PMA; however, the Streamlined PMA is for a device in which
the technology and use are well known to FDA.
