The Approval Process: Medical Device versus a New Drug

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Table of Contents

Introduction
Operations
Similarities
Differences
Conclusion
References

Introduction

Worldwide, Americans enjoy a higher sophistication and choice when it comes to drugs and medical devices. New drugs and medical devices are constantly being discovered and developed. Thus, it has become important for the federal government to certify which drugs and medical devices are safe for use. Both medical devices and new drugs undergo various approval processes before they are released into the general population. Such activities are carried out by the Food and Drug Administration (FDA) (Sweet, Schwemm, & Parsons, 2011). Even though this agency plays a major role in approving the use of the various drugs and medical devices locally, it is also a significant player in determining their exportation.

Thus, a drug that has not been approved by the FDA will not be easily accepted in international markets. The FDA also acts as a reference point for foreign governments in determining whether they will approve specific drugs and medical devices from the U.S. In any given year, the FDA removes approximately 1-2 new drugs and 6-8 medical devices from the market because of safety concerns (Whitmore, 2012).

Operations

The Centre of Drug Evaluation and Research (CDER) is the body that the FDA uses as the regulatory body to oversee the safety of drugs and medical devices. The CDERs main task is to evaluate new drugs before they are released into the market. Thus, it prevents quackery and provides information to both doctors and patients on how they can use drugs (Sweet, Schwemm, & Parsons, 2011). Both drugs and new devices are considered by the FDA. This includes analysis of such drugs and medical devices to ensure that their benefits are way more than the health risks arising from their use.

Similarities

Drug companies are mandated to conduct tests on a new drug before they can sell the drug. The test results are then sent to CDER to show that the said drug is effective and safe with regard to its intended use. CDER has various professionals who analyze the drug further. The data from the company is analyzed by these individuals, including a proposal for labeling and drug use. This is similar to new medical devices. Generally, the manufacturing company tests the devices and forwards the results to the FDA. These results are then analyzed to ensure that they are true, the devices are safe, and they will work as expected (Garber et al., 2000).

For both medical devices and new drugs, the approval process involves less research with regard to the safety, quality, and effectiveness. The company selling the new devices and drugs is expected to conduct detailed research. The FDA is only involved in analysis of the research data provided by the company and only carries out limited research on its own. The data collected is determined by the various steps a manufacturer takes during the development of a new drug or device. Conducting lab tests on the new drug or device is usually the initial step in the approval process. This is done to determine what exactly the drug intends to do (Whitmore, 2012). Thus, the researchers become aware that the drug has various medical implications.

In comparison, new medical devices are categorized into various classes depending on the risks that arise from the specific device. They are categorized into three classes. The first class deals with general controls. This means that devices under this category have passed the general safety requirements required by the FDA. The second class is dependent on how the device is used. Thus, such a device is ranked depending on what special controls are required, besides the general controls. This can involve having labels on the device, testing, and performance standard requirements. Devices that are ranked as class three usually have medical implications on the user. These are devices used in the support or sustenance of life, implants, and can cause injury. Thus, both new drugs and medical devices undergo this stage, but they are usually just a concept. In other words, they have not undergone any production, but they are only an idea that the FDA is informed about (Garber et al., 2000).

Both new drugs and medical devices are patented during the initial phases of their development. Thus, the agency considers the intellectual ownership during the approval process. In case of new drugs, other companies can apply to produce generic drugs later through the FDA. For most of them, they will not undergo a stringent approval process if they follow all the requirements of the original drug manufacturer. In the case of new medical devices, manufacturers rarely let other companies produce their devices. This is usually related to the economic costs of a machine, thus a company would want to retain its profits if there is a small demand for the new medical device (Garber et al., 2000).

The FDA has a shorter approval process for a new medical device that has proven to work just as good and safe like an already marketed medical device of similar functionality. This is known as the 500(k) process (Sweet, Schwemm, & Parsons, 2011). The general and special controls should be met before a device is allowed into the market. The device is approved when it is considered to have followed all requirements. This is the same case with generic formulations of drugs. Thus, the only data required is information that approves the drugs bioequivalence to the original drug. Moreover, clinical trials are not conducted because it takes a shorter time to be approved. The manufacturer submits an Abbreviated NDA (ANDA), which leads to the shortened time. This abbreviated process has its beginnings on the Hatch-Waxman Act passed in 1984 to reduce the approval process for generic drugs (Whitmore, 2012).

The approval process also involves clinical trials. Medical devices go through a short clinical trial period in comparison to new drugs. Moreover, the FDA is involved in the approval of the clinical trials. Thus, it can stop or cancel the clinical trials if problems are encountered during the process. Even though the trials conducted before a new drug or device is marketed can provide conclusive information on its effects on the larger population, the results may not be accurate. Thus, the FDA continues to monitor both drugs and new medical devices after release into the market.

Differences

The main differences often arise when it comes to the quality assurance methods used by the FDA. The methods applied for the new drug involve a higher percentage of human subjects during clinical trials in comparison to new devices. The FDA will grant temporary approval allowing only the manufacturer to conduct post marketing studies after a new drug has passed testing through CDER. This is done to determine the drugs effect on a smaller market before more people can access the drug. Thus, the safety concerns and cost/benefit issues are considered during this time. The drugs efficacy is also assessed. In comparison, new medical devices are not allowed into the market, until the FDA is assured of their safety for use by humans (Sweet, Schwemm, & Parsons, 2011).

The approval process for new devices involves comparing them to devices that existed in the market before 1976. The devices made prior to 1976 were known as predicate devices, thus they act as a reference point when reviewing application for new devices. In comparison, new drugs do not undergo a comparison with drugs that are already made. Thus, drugs are considered as unique and the effects of each drug are based on trials conducted on the drug and not past experience.

It is the responsibility of the Food and Drug Administration to conduct quality control tests that certify drugs as suitable for treating people. A drug can easily cause death in comparison to a device. This increases the risks involved because a drug is intended to help a sick individual regain their normal condition. Drugs also have higher risks in relation to allergic reactions resulting from the use of such drugs. In some cases, the allergic reactions may be severe enough to lead to death. Thus, new drugs undergo a longer approval process in comparison to new machines. The approval process of new devices varies depending on the use of the device. Some devices may be very expensive and important. Thus, new medical devices go through a shorter approval process in comparison to a new drug (Whitmore, 2012).

The manufacturer of a new drug is supposed to submit their application for their Investigational New Drug (IND) during the approval process. This document shows the results of tests conducted on animals. The FDA can then approve whether the manufacturer can carry out further tests on human subjects. Despite this, several studies are still carried out on humans before the drug is approved. There is a major difference when it comes to new devices where tests on humans are not carried out before approval. Many medical devices, especially those categorized as class three, have to await the FDA approval before human trials can be conducted.

The FDA conducts random or planned inspections of manufacturing facilities to ensure that they meet the requirements that had been agreed upon. Moreover, a database has been established by the FDA to act as a reporting site for problems that may arise from the use of new drugs or medical devices. Thus, the FDA remains aware of the effects of the new drugs even after they are released into the market. This is different in the case of machines whereby few devices undergo randomized controlled trials (RCTs). Moreover, there are more device applications going through the FDA in comparison to new drug applications. This makes it harder for the FDA to conduct trials on all devices. Thus, inspection is prioritized depending on a devices safety and not efficacy (Benzon et al., 2013).

Conclusion

The procedure of approving a medical device is almost the same as that of approving a new drug. However, there are phases that differ between the two procedures. The approval process is usually guided by the safety and use of the new drug or device. In the U.S., the approval process is conducted by the FDA to ensure that the products released into the market have met various safety standards and are effective in usage. The approval process for a new drug is more stringent and takes more time compared to the process of approving a new medical device. Safety and efficacy assessments are conducted even after the new drug or device has been released into the market.

References

Benzon, H., Rathmell, J. P., Wu, C. L., Turk, D. C., Argoff, C. E., & Hurley, R. W. (2013). Practical management of pain (5th ed.). Philadelphia, PA: Elsevier/Saunders. Web.

Garber, S., Ridgley, M. S., Taylor, R. S., & Meili, R. (2000). Managed care and the evaluation and adoption of emerging medical technologies. Santa Monica, CA: RAND. Web.

Sweet, B. V., Schwemm, A. K., & Parsons, D. M. (2011). Review of the processes for FDA oversight of drugs. Journal of Managed Care Pharmacy, 17(1), 40-50. Web.

Whitmore, E. (2012). Development of FDA-regulated medical products: a translational approach (2nd ed.). Milwaukee, WI: ASQ Quality Press. Web.

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