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Question No 1: While seeking a new Class III indication for a medical device that is currently on the market as Class II, a company received a vote of "non-approvable" from an FDA Advisory Panel. Possible course of action includes all of the following EXCEPT? A. B. C. D.

Continue marketing the device for its Class II indication Update the current labeling to include the new indication Proceed with a PMA submission to FDA Request a face-to-face meeting post-panel meeting with FDA

Answer: B Question No 2: Company X is developing marketing materials for a Class II medical device known as "Y". In one marketing piece, the company talks about the clinical data supporting the marketing of the device. Which of the following statements is illegal and should NOT be included int eh marketing materials?

A. Company X has conducted clinical studies to demonstrate safety and effectiveness of device Y B. Device Y is approved for marketing in the US C. Warning: Device Y i not compatible with MRI equipment D. Caution: Device Y, when improperly deployed, can cause bleeding

Answer: B Question No 3: The Quality System Regulation calls for the manufacturer of finished devices to carry out all of the following EXCEPT? A. Quality audits conducted by individuals who do not have direct responsibility for the operation being audited.

B. Annual audits of operations C. Document the dates and results of quality audits and re-audits D. Have findings reviewed by management responsible for the matters audited

Answer: B

Question No 4: The following are required per 21 CFR Part 820 Quality System Regulation (QSR) EXCEPT? A. B. C. D.

Device History Record (DHR) Device Master Record (DMR) Design History File (DHF) Quality Manual (QM)

Answer: D Question No 5: What is the formal early collaboration meeting that was implemented throught the Food and Drug Modernization Act (FDAMA)?

A. B. C. D.

PDP Meeting Agreement Meeting Pre-IDE Meeting Pre-PMA Meeting

Answer: B Question No 6: You are a German-based device manufacturer whose device is packaged in Ireland and sold in the US through a US-based company. The 510(k) was written by a contract organization. The label of our product may indicated any of the following EXCEPT" A. B. C. D.

The principle place of business in the US The packaging location address The address of the contractor who submitted the 510(k) The address of the distributor

Answer: C Question No 7: A company intends to add an indication for use to a 510(k) device that is currently being marketed but has not yet been distributed. Which type of submission is appropriate?

A. B. C. D.

A PMA An Investigation Device Exemption A Special 510(k) A traditional or abbreviated 510(k)

Answer: D Question No 8: A company begins to market its new device, a pacemaker (Class III) the same day that its regulatory professional mails the Premaket Approval Application (PMA) to FDA. The pacemaker is considered: A. B. C. D.

Legally marketed Misbranded Investigational Adulterated

Answer: D Question No 9: A medical device company allows its sales force to maintain a product inventory in the field.

The device has an expiration date indicated on its labeling. A sales person notes that one of his products has expired and contacts the headquarters office for direction. He is told to return the product to the headquarter office for replacement. The return of this product is considered as what type of recall?

A. B. C. D.

Not a recall-it is considered normal stock rotation Class I recall Class II recall Class III recall

Answer: A Question No 10: When FDA declares a device from a 510(k) application to be Not Substantially Equivalent (NSE) and requires a PMA. What is the most practicable first option for a company at this stage?

A. File a PMA immediately B. Petition CDRH to down-classify the device (de novo process) C. Resubmit a 510(k) with new data to demonstrate the device is at least as safe and effective as the predicate D. Submit this product for approval in Europe

Answer: C

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