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RAC DEVICES Exam Prep 2025 | 60 Questions
with 100% Correct Answers | Verified | Latest
Update 202 5 | Graded A+
A company is performing routine site monitoring of its pivotal clinical study for a blood sugar meter and finds one site has not consented one-third of its subjects properly. What is the FIRST thing the company needs to do? A. Stop the entire study B. Inform FDA and ask for guidance C. Re-train the study staff, including the principle investigator D. Re-consent all improperly consented subjects - ✔✔D Re-consent all improperly consented subjects You are tasked with helping develop a regulatory intelligence procedure for continuously collecting and analyzing regulatory information pertaining to chromosome enumeration probes (CEPs), a type of in vitro diagnostic (IVD)
device. Which of the following inputs should be considered when creating this procedure? A. Sources of content (for example - blogs and white papers) B. Identification of applicable government publications C. Databases containing international standards and, D. All options listed above should be considered. - ✔✔D. All options listed above should be considered. Ensuring a medical device meets defined user needs and intended use is accomplished through which type of validation? 0 Design, 1 Device, 2 Process, 3 Product - ✔✔Design
Which of the following represent cybersecurity information needed for a 510(k) submission? A. Objective evidence of manufacturer participation, B. A list and justification for all cybersecurity c, C. Device instructions for use and product specific, B and C - ✔✔B and C Your company manufactures a patient scale that sometimes fails testing during a certain stage of production. When this happens, the product is inspected, repaired, and retested by a technician in the servicing department, and then returned to production for further manufacturing. There exists only a small number of causes for failure at this stage, and the repair solutions are simple and fast. In order to help ensure compliance of this activity with ISO 13485, which of the following MUST bein place?
A. Training of the servicing technician on all manufacturing, B. Annual internal audit of this activity to ensure, C. Documented procedures that describe the inspection, repair and retesting activities. A and B - ✔✔C. Documented Procedures that describe the inspection, repair, and retesting activities. Prior to initiating a clinical trial, the company discovers that the non-clinical study results were incorrectly documented. Which of the following is the MOST appropriate course of action for the company? 0 Notify the IRB ethics committee and obtain re-approval, 1 Proceed with the clinical trial, but initiate p, 2 Re-evaluate the nonclinical data before proceeding with the clinical trial,
The Quality System Regulation calls for finished device manufacturers to carry out all of the following EXCEPT 0 Quality audits conducted by individuals who do , 1 Annual audits of operations, 2 Documenting the dates and results of quality audit, 3 Having findings reviewed by management responsible - ✔✔Annual audits of operations What does the 510 (k) number, such as K130001, mean, and what does it encode? A. The first two digits designate the calendar year the submission was received B. The last four digits represent the submission number for the year C. Designates the number of submissions made by a company - ✔✔A and B
You are the regulatory compliance expert in the organization and are required to suggest the mechanism to successfully achieve conformity to QMS, in regard to identifying potential compliance issues. Which of the following is the LEAST effective option? 0 Conducting internal audits against applicable re, 1 Regularly reviewing FDA Warnings Letters issued , 2 Listening to podcasts on medical device industry compliance trends 3 Using a CAPA system, investigating potential int - ✔✔Listening to podcasts on medical device industry compliance trends. A regulatory professional is negotiating with the FDA on a product's final labeling. The company's management is adamant about including a claim in the labeling, while the FDA is proposing a more restrictive claim. What is the regulatory professional's BEST course of action?
0 True, 1 False - ✔✔False The FDA has published in the Federal Register a notice on the issuance of a new draft guidance covering the testing of the device type manufactured by your company. You lead a cross-functional team in the review of the draft guidance, and it is the opinion of the team that the guidance contains assumptions that do not adequately consider the technology used in the design of your devices. What is the BEST option for addressing this situation? 0 Work with the cross-functional team to prepare comments and submit to FDA on Regulations.gov within the stated comment period, 1 Notify executive management that the new guidance, 2 Email DICE to request written exemption from the, 3 Prepare an internal memo with a rationale for wh - ✔✔Work with the cross- functional team to prepare comments and submit to FDA on Regulations.gov within the stated comment period.
Which of the following sections MUST be present in a Clinical Investigation Report for a product marketed in the EU? A. A description of the selected outcome measures a, B. Baseline demographic and clinical characteristic, C. A detailed description of the device design and , 3 A and B - ✔✔A and B Manufacturers of Class IIb devices under EU MDR are required to submit which of the following: 0 Periodic Safety Update Report, every two years, 1 Post-Market Surveillance Report, 2 Periodic Safety Update Report, annually, 3 All of the above,
2 It is not necessary to show conformance through, 3 Testing conducted by the manufacturer showing c - ✔✔Testing conducted by the manufacturer showing conformance to harmonized standards What regulatory information is included in the Official Journal of the European Union? 0 Draft guidelines relevant to pharmaceuticals, 1 Notices of product recalls within the EU, 2 Proposed and final EU legislation, 3 Summaries of final EU legislation in every EU l - ✔✔Proposed and final EU legislation What does a regulatory professional need to address when preparing an internal audit plan? 0 The audit scope, importance of the process, fin, 1 The audit scope, findings from previous audits,,
2 The findings from previous audits, selection of auditors, 3 The importance of the process, findings from previous audits, and follow-up activities and actions taken with verifications - ✔✔The audit scope, importance of the process, findings from previous audits, and selection of auditors Your Notified Body is classifying your device differently from you assessment. After reviewing the classification rules, you are certain your classification is correct; however, the Notified Body is not willing to reconsider. What is the BEST strategy to resolve this situation? 0 Change Notified Body, 1 Discuss with the Notified Body the reasons for , 2 Ask the Notified Body to get an opinion from it, 3 Sign the Declaration of Conformity and CE mark - ✔✔Ask the Notified Body to get an opinion from its competent Authority The Declaration of Conformity supporting the CE marking of a Class I medical device includes all of the following EXCEPT:
A US manufacturer CE marks its Class IIa medical device and labels it in English, French, German, Italian and Spanish. A French-based distributor has a contract with the company to distribute, market and supply the product in the UK, France, Germany, Italy and Spain. A hospital in Sweden calls the distributor requesting a regular supply of the product. The distributor should: 0 Notify the manufacturer and request the label be, 1 Supply the product as labelled since English is spoken there, 2 Not supply into Sweden until a local distribution, 3 Translate the label into Swedish and ship the product - ✔✔Notify the manufacturer and request the label be changed to include Swedish To maintain a valid CE Mark certificate for devices under Annex II, the manufacturer should: 0 Collect all relevant new information, compile it,
1 Collect all relevant new information, compile it and update technical files for audit, 2 Collect all relevant new information and update the technical documentation at the end of the five-year period, 3 Follow the newly published EN standard to update - ✔✔Collect all relevant new information, compile it and update technical files for audit and review by the Notified Body as required during the five-year period following CE marking A manufacturer sells 1,500 medical devices in the two months following launch. A user, but not a patient, is seriously injured while using the medical device. The investigation reveals the cause to be an error in a software subroutine that has a one in 195,000 chance of happening. Management is concerned about how the incident may result in serious problems in the marketplace. What recommendation is MOST appropriate for the regulatory professional to make to management?
An article published in a scientific journal based on experiences in a Korean hospital indicates that there are problems with the use of a manufacturer's CE- marked medical device. Medical intervention was necessary to prevent serious injury to patients; however, it was determined that an FSCA is not necessary. Whom should the manufacturer inform of the situation? 0 CA, 1 NB, 2 EU Commission, 3 No reporting is required. - ✔✔No reporting is required The internal audit area of a company is itself due for an internal review and audit. The internal audit procedure was written by an external regulatory/quality consultant. The quality manager is responsible for setting the internal audit schedule, ensuring audit documentation is complete and that actions are taken. The BEST person to conduct this audit is the:
0 Document control manager, 1 Regulatory quality consultant, 2 Quality manager, 3 Quality inspector who reports to the quality manager - ✔✔Document control manager The marketing department asks your opinion regarding shelf-life labelling for a new medical device to be able to place it on the market as soon as possible. Which of the following should you advise the marketing department to do? 0 Do not put a "use-by" date on the device, 1 Perform prospective accelerated aging studies for the minimum time periods customers will accept 2 Label as they see fit, to be followed by retros,
