A stent company
The use of the Novel Bare Metal Coronary Stenting System (NBMCSS) which uses a product that is fictitious is showing the FDA’s Premarket Approval requirements. The Premarket Approval is the most important and required signatory process in approving the medical devices. This process is the most important in the Food and Drugs Administration center for every device and the radiological health (CDRH). The main purposes of this case study are to give the students the knowledge of the regulatory process. The Novel Bare Metal Coronary Stenting System provides the best learning grounds for the students to learn effectively. Learning concepts gained through the Novel Bare Metal Coronary Stenting System can be used in practical research. Novel Bare Metal Coronary Stenting System exposes the students to a new world of the medical devices application such as First In Human (FIH) and Investigation Device Exemptions (IDE). Novel Bare Metal Coronary Stenting System also is applied in order to get a PMA application and the data required (In Curtis, 2013).
Novel Bare Metal Coronary Stenting System distinguishes mostly from other stenting systems which are in the market. The novel is intended to reduce any incident of restenosis and also the thrombosis while still opening up any restricted coronary arteries which allow for blood flow. The novel resides so much in claiming to reduce any incidence caused by restenosis and the thrombosis while comparing the same with any of the existing stents. The Novel Bare Metal Coronary Stenting System is what is known as a cardiovascular implant which is a risky device which supports the patients with restricted coronary vessels. These diseases to the vessels can be a prime cause of heart attack or ultimately the death of the individual. The Food and Drugs Authorities (FDA) have taken into considerations the need for encouraging the innovation of medical devices which will address the needs for improved care for patients and clinical needs (In Curtis, 2013). This would be of much help when the already in place is faulty and there is the need for treatment. The underway guidelines have been projected in order to facilitate the clinical evaluation of any medical services which are in the United States following the regulations set by Investigational Device Exemptions.
The Premarket approval (PMA) is a regulatory and a process of FDA that reviews and evaluates the safety of any device used in clinical services in class iii. The class iii are all those devices which support the life of a human, they are substantial in nature for preventing any impairment of human health, or injuries (In Curtis, 2013). Due to the increase or the high risk involving the devices under this class iii, the food and drug authority has stipulated that the general and the special control on their own prove to be insufficient in assuring the effectivity and safety of devices under this class. Therefore, for these devices to be available in the market, certain acts such as section 515 of the food and drug act must apply. The premarket approval has been one of the most severe device marketing types of application which are required by the food and drug authority (In Curtis, 2013). Any applicant must first receive an approval from the food and drug authority through a premarket application in order to market any devices. Premarket approval is basically based upon the determination as required by the food and drug authority which the premarket approval having sufficient evidence scientifically which ensures that every device is effective and safe for use.
An early feasibility enables for clinical evaluation of the devices in order to provide the evidence or the rules and the initial clinical safety of the data. The study can be effective and most appropriate in early device growth once the clinical knowledge and familiarity is important since the nonclinical verification methods are unavailable or enough to offer the data required in advancing the progressive processes. Like it happens through every medical device study, the commencement of the practicality study has to be allowed by the correct value and threat analysis and adequate individual matter security guidelines (In Curtis, 2013). The federal food and drug act have set forward the framework for the food and drug authority in order to allow the devices for investigation use which is an exception from certain requirements so as the experts qualified by the scientific training and experience can allow for investigation of safety and their effectiveness. Such exemptions are known as the Investigation Device Exemption (IDE). In the case of devices of significant risks, the sponsor has to first submit an IDE form of application and has to obtain a foodstuff and remedy authority approval (Food and Drug Administration, 2013). The federal food and drug act highly recognize that the data encompassed within the investigation device exemption tender can fluctuate on basis of the investigation. Also, the procedure and the conditions can appropriately vary depending on the requirements to allow the changes to be conducted in the devices which are in conjunction with the exemption during the testing that is conducted according to the clinical testing plan required under the federal food and drug act. Procedure and the condition can also vary depending on the quantity of human subjects who are to be tested by the device and also the duration and the scope of clinical testing which is conducted under the exemptions. The feasibility study must be effective according to the guidelines under the federal food and drugs acts. Such requirements include the investigation plan that explains the information to be contained inclusive of the reason for the investigation, the risk analysis, procedure of monitoring, protocol, labeling, and any information regarding the Institution Review Boards (IRB) (In Curtis, 2013). The application that explains the time when the sponsor must submit the IDE application and the information which the IDE must contain are inclusive of the investigational report and the plan of any previous investigation. The report of any previous investigation gives more information about the report and has to include reports involving prior testing of animal, clinical, and laboratory tests from the device. The supplemental applications provide more information on any changes to the devices and the investigation plans and the basic information included is the prior food and drug authority approval and the right manner to notify the food and drug authority of any changes which do not require any previous approval (In Curtis, 2013). The early feasibility study is conducted in order to get the clinical safety of every device that is used, to check whether the devices will be delivered effectively, installed and used in the right way, to ensure the operator techniques are understood effectively, to ensure the safety of the clinical devices, and to allow for human factor. Under the reports of the previous investigation, the information to be provided should always be presented in three basic main sections which are: executive summary, detailed report, and the background.
The background section mainly emphasizes on the unique aspects of the design of the device and the intended patient number that will be considered when the food and drug authority evaluates if the information provided has justifiable early feasibility study. The section should always describe the clinical context of the feasibility study, the design concept, and the summary justification which regards the amount and the type of details needed in support of the early feasibility study of a specified number of patients, inclusive of the comments, comparison to what is expected in order to support the larger clinical study. The clinical context feasibility study contains the condition of the clinical devices intended to be used, the standard care including the types and the risks, benefits which may be realized from the device study, and the rationale for showing the targeted number of people to the risks (In Curtis, 2013).
The executive summary section gives more information about the summary provided and a brief explanation of the same information and reasons it is adequate to study. This section should include a description of the nonclinical testing which has been performed, device evaluation study, and a table describing the purpose of every test and analysis. Detailed report provides the reports for every test conducted and any additional information available in support of the early feasibility study. Information included in the detailed report include the individual report for every laboratory and bench test, computational modeling and the animal study, brief information of the leveraged nonclinical data depending on the source of the data such as the reports published, and any relevant clinical data summary (In Curtis, 2013).
The design concept of the feasibility study should include an IDE which has the information to clearly give more details on the design concepts. Such information includes the description of the device, the intended use, the conditions of usage, and the minimum design of the devices. Under the description of the device, the physical, principle of application, and how the important features should be reviewed. Device evaluation in the executive summary should give more information about the justification of the leverage data and the testing conducted in the feasibility study. The purpose of evaluation is to facilitate the food and drugs authority understanding of the value of the information and the reason why the information is included in the previous investigation report submitted in support of the IDE approval (Food and Drug Administration, 2013). To minimize the effective use of sponsors and the food and drugs authority sources, it advisable that the sponsor should consult the food and drugs authority and both parties to reach to an agreement strategy prior to the sponsor conducting the pre-sub interactions. This is very important when there is no available guidance or a voluntary standard specific to the device and the intended use which is proposed to be studied, when the sponsor has provided less of the nonclinical data compared to the expected feasibility study, and when a certain clinical test is more relevant than all the others in addressing the basic safety device information.
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1st column |
2nd column |
3rd column |
4th column |
5th column |
6th column |
7th column |
8th column |
9th column |
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Knowledge base |
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Device attributes |
Potential failure modes |
Potential effects of the failure |
Devices design information |
Supportive data |
Nonclinical device testing |
Clinical study mitigation |
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Leverage nonclinical data |
Supportive clinical data |
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Potential device effects |
Potential clinical effects |
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Device strategy evaluation table
Device evaluation strategy for a feasibility study should always be based on the risks and the benefits. The feasibility study should always be focused on mostly identifying the data needed in addressing the significant safety concerns and the basic device functions. The basic process of creating a device strategy can also divide into four main parts such as device deconstruction, knowledge base, and the mitigation strategies, fill the gaps, and evidence gaps. Device deconstruction identifies the attributes that are needed for the device to achieve for every goal needed (Food and Drug Administration, 2013). These goals are such as the potential failures, and the effects of the failure. Knowledge base and the mitigation strategies give more information about what is known from the devices, leveraged clinical and nonclinical from either the internal or the external informants. The evidence gaps mainly identify the gaps from the existing information with an indication that the additional testing may be needed in order to justify the study considering the knowledge base and always focusing on the attributes intended for use. Filing the gap focuses on identifying the complete and the evaluation of the devices attributes and any potential associated with the failure modes (In Curtis, 2013). This is in consideration of the evidence gaps, clinical contexts of the feasibility study, and the potential types and the frequencies which may be caused or associated with the devices strategies. Any effects of the unique aspects of the devices intended for use should be clearly emphasized in the device evaluation strategy.
References
In Curtis, P. A. (2013). Guide to US food laws and regulations.
In Chen, X., & In Wong, S. (2014). Cancer theranostics.
Food and Drug AdminiStration, (2013). Guidance for Industry and Food and Drug Administration Staff
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