Medical Device Regulation

What steps does a manufacturer need to take for any device design change it is implementing? a. Document the change in Device Master Record (DMR) b. File a new supplement to existing 510(k) or PMA c. All of the above d. None of the above

Correct A. Every device design change needs to be documented in the Device Master Record (DMR). Filing of a supplement to existing 510(k) or PMA is only required if the change significantly alters the safety and effectiveness profile of a technology.

What goal is not part of a phase II safety study? a. Obtain preliminary safety data b. Obtain preliminary effectiveness data c. Obtain info needed for pivotal study d. Investigate safety in limited number of patients

Correct A. Obtaining preliminary safety data is part of the phase I feasibility study, not part of the phase II safety study.

Which of the following are necessary requirements for establishing substantial equivalence in a 510(k) application? a. Same intended use b. Same technological characteristics as predicate device(s) c. None of the above d. All of the above

Correct A. Same intended use is a necessary requirement. Same technological characteristics is a decision criterion, too, but not a necessary one. As long as technological characteristics are changed and it can be reasonably established that no new questions of safety and effectiveness are raised through this change, substantial equivalence can be established.

Safety and Effectiveness determination by FDA needs to be based on a. Any source of information submitted to FDA by the sponsor b. Valid scientific evidence c. All of the above d. None of the above

Correct B. 21CFR860.7 requires that decision-making about a device needs to be based by valid scientific evidence, as described and outlined in this title of the code of federal regulations.

What is the percentage of devices that enter the market based on approved Premarket Applications (PMAs)? a. About 10% b. About 1% c. About 3% d. About 5%

Correct B. About 1% of devices are approved through a PMA, about 44% are cleared to market via the 510(k) premarket notification process, and about 55% of devices are exempt.

Is the following statement true or false: "FDA performs clinical trials to determine whether a device is safe and effective for use in humans"? a. True b. False

Correct B. Clinical trials are arranged by the manufacturer/sponsor, and the results are presented to the FDA for review in their approval decision-making process. FDA has own labs to perform some animal work for specific tests and verification, though, but they do not qualify as clinical trials.

How are devices called that were on the market before FDA started regulating medical devices in 1976? a. Predicate devices b. Pre-amendment devices c. Pre-approved devices d. None of the above

Correct B. Devices that were on the market before FDA started to regulate devices in 1976 (statutory basis: medical device amendments) are called pre-amendment devices. Pre-amendment devices are a subset of predicate devices.

Statement: "Every clinical trial requires a control group" a. This statement is true b. This statement is false

Correct B. Especially in medical device trials, there can be situations in which it is difficult or even impossible to include a control group. So-called single-arm studies without control group are therefore regularly performed. In these situations, comparison information is oftentimes performed from previous trials of alternative technologies, or the literature.

Statement: "The 1976 Medical Device Amendments to the Food, Drug & Cosmetics Act form the sole statutory basis for regulation of medical devices in the United States" a. This statement is True b. This statement is False

Correct B. Even though the 1976 "Medical Device Amendments" to the Food, Drug and Cosmetics Act (FD&C) are a vital part of the statutory basis for regulation of devices by the FDA, they are not the sole basis. The Safe Medical Devices Act (SMDA) of 1990, the FDA Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002 outline important aspects of FDA's work, too, and are therefore integral parts of the statutory basis for medical device regulation by the FDA.

Which of the following is usually not included in an informed consent document? a. Information about other possible treatments b. Expected cost-effectiveness information about the treatment c. Possible benefits of the treatment d. Expected duration of the study participation

Correct B. Expected cost-effectiveness is usually not included in an informed consent document, while all other listed items are.

"FDA prescribes the exact way in which quality systems need to be implemented" a. This statement is true b. This statement is false

Correct B. FDA leaves some leeway to manufacturers as to how to implement their specific quality system.

"The FDA and CMS have different missions, but use the same criteria for their decision-making about clearance or payment for a device" a. True b. False

Correct B. FDA needs to ensure that a device is safe and effective. The Centers for Medicare and Medicaid (CMS) require - for reimbursement - that a device be "reasonable and necessary".

Which of the following criteria is not used by the FDA to decide on market clearance of new devices? a. Safety b. Cost Effectiveness c. Effectiveness

Correct B. FDA's decision making is solely based on an assessment of safety and effectiveness (the "risk-benefit profile" of a technology). Costs are not taken into account in any of FDA's decision-making.

FDA's device classification is a. Application-based b. Risk-based c. None of the above

Correct B. FDA's device classification is risk-based. Class I devices are common, low risk devices. Class II devices are medium risk devices, and Class III devices are high-risk devices.

What is FDA's Statutory Mission? a. Approve Safe and Effective Devices and Pharmaceuticals b. Promote and Protect the Public Health c. None of the above

Correct B. FDA's mission is to promote and protect the public health. This mission is applies to all aspects of regulation by FDA, and is not limited to medical devices.

Statement: "All clinical evaluations of investigational devices must have an approved IDE before the study is initiated?" a. This statement is true b. This statement is false

Correct B. If a study is exempt, it does not require an approved IDE before clinical evaluations are undertaken. In most cases, however, an approved IDE is required, though, when a device is tested in clinical trials

Statement: "Premarket Notifications (510(k)) do not require submission of clinical data" a. This statement is true b. This statement is false

Correct B. In about 10-15% of all 510(k) premarket notification applications, clinical data is required to demonstrate substantial equivalence to a predicate device.

Statement: "FDA's Office of Device Evaluation (ODE) is the only office of CDRH charged with regulation of medical devices" a. This statement is True b. This statement is False

Correct B. Several other offices of the Centers for Devices and Radiological Health (CDRH) are also involved in the regulation of medical devices, including the Office of Compliance and the Office of Surveillance and Biometrics.

Standard Operating Procedures (SOPs) are part of the a. Device Master Record (DMR) b. Quality System Report c. Standard Quality Assurance Procedures (QAP) d. None of the above

Correct B. Standard Operating Procedures (SOPs) and Standard Quality Assurance Procedures (QAPs) are part of the Quality Systems Report.

Surrogate endpoints are appropriate and valuable in clinical trials if a. They are not correlated with the true clinical endpoint b. True clinical endpoints are delayed c. None of the above

Correct B. Surrogate endpoints should be used if they are closely correlated with the true clinical endpoints of interest, and if these endpoints are delayed or confounded.

"The 510(k) process can be used both for previously approved and new indications for use" a. This statement is true b. This statement is false

Correct B. The 510(k) process can only be used if the indications for use of the new product are similar to the indications for use of the predicate device. If this is not the case, substantial equivalence can not be established. Any new indication requires a PMA.

Statement: "The labeling of an investigational device can be similar to the one of an already marketed device" a. This statement is true b. This statement is false

Correct B. The labeling of an investigational device needs to clearly and visibly include the statement "For Investigational Use Only". It can therefore never be similar to the labeling of an already marketed device

What is the 'gold standard' for collecting evidence about the performance of a medical device? a. Case-series b. Randomized controlled trial c. Other

Correct B. The randomized controlled trial (RCT) is regarded as the gold standard for collecting evidence about device performance. In an RCT, participants are randomly (i.e., by chance) assigned to one of two or more treatment arms of a clinical trial.

How many IRB approvals does a multi-center clinical study require? a. One IRB b. No IRB c. A number equivalent to the number of sites participating d. None of the above

Correct C. An IRB approval is required for every site/ participating institution.

Which of the following qualify as Valid Scientific Evidence? a. Partially controlled studies b. Randomized controlled trial (RCT) c. Studies without matched controls d. All of the above e. None of the above

Correct C. Partially controlled studies, randomized controlled trials (RCTs), and studies without matched controls are all listed in 21CFR860.7 as valid scientific evidence.

Which type of establishment is not subject to GMP? a. Manufacturers b. Contract manufacturers c. Provider organizations d. Repackagers e. Specification developers

Correct C. The following establishments are subject to the GMP regulations: Remanufacturers, Custom Device Manufacturers, Contract Manufacturers, Contract Testing Labs, Repackagers, Relabelers, and Specification Developers, Manufacturers of Accessories, Initial Distributors. Provider organizations are not subject to GMP regulations.

Since when have medical devices been regulated by the FDA? a. 1967 b. 1979 c. 1976 d. 1982

Correct C. The regulation of medical devices began in 1976, when the medical device amendments were added to the existing Food, Drug, and Cosmetics Act (FD&C).

What elements did the Medical Device Use Fee and Modernization Act of 2002 entail? a. Regulation of reprocessed single-use devices b. Third-party inspections c. Additional resources to enhance and accelerate regulation of devices d. All of the above e. None of the above

Correct D. The Medical Device User Fee and Modernization Act (MDUFMA) of 2002 entails the regulation of reprocessed single-use devices, inspections by third parties, as well as additional resources to enhance and accelerate regulation of devices.

The Quality Systems Regulation (QSR) encompasses the following: a. Design b. Production c. Distribution d. All of the above e. a) and b) only

Correct D. The Quality Systems regulation (QSR) encompasses design, production, and distribution of medical devices.

What elements are part of the usual process of establishing safety and effectiveness for a PMA device? a. Human testing b. Bench testing c. Animal testing d. All of the above

Correct D. The usual process of establishing safety and effectiveness for a PMA device is: Bench testing -- animal testing -- human (clinical) testing.

Effectiveness of a device can be measured against a. Status quo of treatment b. Alternative technologies c. No treatment d. All of the above e. None of the above

Correct D. There are several choices against which effectiveness of a new technology can be measured. Oftentimes, the choice is referred to as the "comparison" or "comparison group". Status-quo of treatment, alternative technologies, and the no treatment option are all possible comparisons.

Which of the following are key requirements of a clinical trial? a. Informed Consent b. IRB approval c. Product Development Protocol (PDP) d. All of the above e. a) and b) only f. b) and c) only

Correct E. Informed consent and IRB approval are key requirements of a clinical trial. A Product Development Protocol (PDP) is a regulatory program comparable to the PMA, and is not to be confused with requirements for clinical trials.

With regards to device problem handling, GMP regulations specifically outline a. How responsibilities should be assigned b. How device failure analysis should be performed c. When to stop marketing of a device d. All of the above e. a) and b) only

Correct E. The GMP regulation gives clear advise of how complaints should be handled (-> Complaint Handling System), how responsibilities should be assigned, how device failure analysis should be performed, and what sources of information a manufacturer should use to detect device problems. It does not give advice on when to stop marketing of a device (this is a decision to be taken by the FDA upon receipt of complaint data from the company).

What steps does FDA take to determine compliance with the GMP requirements? a. Inspection of operations b. Inspection of records c. Monitoring of device problem data d. All of the above e. b) and c) only

True D. The FDA monitors device problem data and inspects the operations and records of device device developers and manufacturers to determine compliance with the GMP requirements in the QS regulation.