Question

15. Pick the most correct answer regarding premarket approvals: a. Once the initial device in a new category of technologies is approved by a FDA pathway, subsequent devices can follow a 510) process using this as a predicate b. PMA applications are reviewed by a panel of experts which makes the decision whether the device is approved or rejected c. Although the FDA review period for PMA submissions is 180 days, approval usually requires at least two cycles of requests from the agency and responses d. PMA approval is typically granted based on a pilot clinical trial, with a proviso that post-approval data be provided by the sponsor 16. Which of the following statements about medtech reimbursement in the U.S.is false? a. Most reimbursement codes are maintained by the Centers for Medicare and Medicare Services (CMS) except for CPT codes, which are managed by the American Medical Association (AMA) b. New reimbursement codes are issued for new technologies, not new procedures Although private payers have traditionally used the same coding system and approach to reimbursement as Medicare, they are increasingly likely to make independent decisions based on the goals and objectives of their individual plans d. Obtaining a reimbursement code is for a new device is important, but coverage policies and payment determinations are also essential before reimbursement will be granted by public or private payers 17. Indicate which of the following reimbursement codes, ICD-10 (previously ICD-9), CPT, APC, MS-DRG, and HCPCS Level II, corresponds to each of the listed descriptions. Description Code (enter below) Codes for describing hospital outpatient services Codes for classifying patient diagnoses and mortality data from death certificates Codes used for supplies and services obtained outside the physician office that are not covered by a CPT code or APC code Codes for describing physician services Codes for describing the procedures and other services performed in a hospital setting 18. When developing a prototype, breaking down a concept into smaller "functional blocks can be important in helping an innovator better understand which aspects of the concept are truly novel and which aspects represent the highest degree of risk that needs to be proven. True or False? 19. A prototype does which of the following? (Mark all correct answers) a. Demonstrates how a device works b. Demonstrates what the device will look like in terms of its shape, color, size, and/or packaging, however it does not demonstrate how a device works c. Demonstrates ergonomics with the final material or a surrogate material, grip, weight, size, etc. d. Performs the desired function and works as intended

Answer 1

15. The correct answer is "option a"

The FDA approved and marketed device which is equivalent to the subject device is called predicate device. Based on predicate device safety and performance data 510k can be processed. However, the predicate device should be equivalent to the subject device in terms clinical (intended use, indication etc), technical (operating procedure and principles) and biological (materials).

b is incorrect - FDA may refer PMA to an outside experts panel.

c is incorrect - the review period may be extended to 180 days and it depends on advisory committee review and data availability.

d is incorrect - it is not applicable for high risk class devices. Clinical studies should compliant with 21 CFR 58, 21 CFR 50 or ISO14155.