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RAC Devices Practice Exam Questions
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A medical device manufacturer is preparing a submission that requires a Declaration of Conformity with design control requirements. What type of submission is the manufacturer preparing to submit to FDA? 0 A PMA 1 A Special 510(k), 2 An Individual Device Exemption (IDE), 3 An Annual Report for a PMA - ✔✔A Special 510(k) A company wishes to expand existing labeling for a medical device to include a new indication for use. What action should the regulatory professional take FIRST? - ✔✔Contact the review division to determine whether a 510(k) or PMA should be prepared. A company is submitting a PMA for a permanent implant. The company has performed biocompatibility testing based on ISO requirements and believes the package is complete. Which of the following testing does the company absolutely need to demonstrate long-term safety of its device: 0 Intracutaneous irritation, 1 Genotoxicity, 2 Acute toxicity, 3 Carcinogenicity - ✔✔Carcinogenicity If a device fails to comply with any paragraph of the QSR is it adulterated? - ✔✔Yes What source should the regulatory professional consult to determine when a product's patent and exclusivity will expire? 0 FederalRegister 1 TheOrange Book, 2 Patentand Trademark Office,
3 CopyrightOffice - ✔✔The orange book An FDA reviewer contacts a regulatory professional with a lengthy list of questions regarding a submitted 510(k) application. Some of the information is not readily available and may require additional data collection. What is the BEST course of action for the regulatory professional? - ✔✔Send a letter with anticipated response time. An IVD submission could be submitted as a(n): A. NDA B. BLA C. 510(k) D. BLA or 510(k) - ✔✔BLA or 510(k) 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 most appropriate? A. A PMA B. An Investigational Device Exemption C. A Special 510(k) D. A traditional or abbreviated 510(k) - ✔✔D. A traditional or abbreviated 510(k) What source should the regulatory professional consult to determine when a product's patent and exclusivity will expire? - ✔✔The Orange Book 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? - ✔✔Negotiate with the review division. A medical device that has just received marketing approval outside the US is to be shipped from the US to a foreign distributor of Company XYZ. Company XYZ contacts the foreign distributor, who confirms the product has not yet been shipped and is still at its warehouse in the US. Company XYZ requests the
B. Field performance, C. Maintenance of product safety D Traceability in distribution - ✔✔D Traceability in distribution The Declaration of Conformity supporting the CE marking of a Class I medical device includes all of the following EXCEPT: A. The signature of the Notified Body B Identification of the directives C. The manufacturer's name and address, D Product Information (name, type or model number - ✔✔A. The signature of the Notified Body A manufacturer of an implanted medical device containing non-viable bovine material of animal origin MUST: - ✔✔Request a certificate for the bovine material. A clinical trial of a medical device can begin how many days after notification is sent to the Competent Authority? A 30 days, B 45days, C 60days, D As soon as Ethical Committee approval is received - ✔✔C 60days A medical device contains electrical parts that could create EMC interference. The manufacturer intends to CE mark the medical device under MDD 93/42/EEC. Which of the following is CORRECT? A. CEmarking the medical device under MDD 93/42/EEC is insufficient. B. CEmarking the medical device under MDD 93/42/EEC is sufficient. C. The manufacturer needs to conform to MDD 89/336/EEC, D. The manufacturer needs to conform to EN ISO 60601 - ✔✔B. CE marking the medical device under MDD 93/42/EEC is sufficient.
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? - ✔✔Ask the Notified Body to get an opinion from its Competent Authority What does a regulatory professional need to address when preparing an internal audit plan? - ✔✔The audit scope, importance of the process, findings from previous audits, and selection of auditors When can a clinical investigation begin for a Class I medical device with Ethics Committee approval? - ✔✔Immediately after the date of notification To whom is the MDD 93/42/EEC addressed? A CA, B Manufacturers, C EUmember states, D NB - ✔✔D. EU member states A new Class III medical device technology is developed by a company, and the company wishes to market the product in the shortest possible time. What first course of action should the regulatory professional recommend? - ✔✔Collect required clinical data A manufacturer's Class I sterile medical device needs a labeling update to add a warning. What is the role of the NB in this situation? A Evaluate the sterilization process., B Issue an EC-type examination certificate., C Review the updated labeling., D The NB is not involved. - ✔✔Evaluate the sterilization process. 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
D NB - ✔✔C. CA in the Netharlands (CA of AR) 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? A CA, B NB, C EU Commission, D No reporting is required. - ✔✔D. No reporting is required FSCA-field safety corrective action Which standard contains guidance on biocompatibility for materials used on medical devices? - ✔✔ 10993 What is the BEST source for determining the format of an MAA intended for submission to an HA? A GMP, B Local HA guidelines, C ICH, D WHO - ✔✔B. Local HA guidelines MAA = Marketing Authorization Application HA = Health Authority
