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Regulatory Approval Process for Medical Device and New Drugs

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Innovation in health care related areas, particularly in medical device and drugs, greatly improve human wellbeing and create tremendous economic growth. Both innovations are certified by the regulatory bodies in most of the countries to ensure the safety. Each country tends to have their own approval process, in this blog post, we will have a quick look at the approval process in the United States as an example for the aspiring entrepreneurs.

In the States, the approval process was managed by the Food and Drug Administration (FDA). The agency determines both the approval of the use of various drugs and medical devices, as well as the exportation potential.

In the FDA, the Centre of Drug Evaluation and Research is the department that directly oversee the safety of drugs and medical devices. A new drug or new device must demonstrate that their benefits outweigh the risks from their use.

General Operations

Despite the differences in pharmaceutical and medical device industry, there are a lot of similarities in the approval process. Both innovations will require initial lab testing to determine the initial use of the product and its various medical implications. Both are likely to involve further clinical research studies to determine the efficacy and safety of the new drug or medical device.

In both new drugs and medical devices approval process, FDA reviews the research experimental design for the clinical trials, and then reviews and analysis the research data provided by the sponsor company to determine the intended use and safety of the new product. Even if the product is approved and moved to the market, the FBA continues to monitor the new products.

Key Differences

The detailed process is different between new drug and new device.

For new drug, the company often will need to complete the lab tests as the initial step. Once completed, the company may apply to go through the Investigational New Drug (IND) stage. If this stage is approved by FDA, the company may conduct the clinical trials. Clinical trials typically contain three stages, each involves a large population of the patients to verify the drug’s efficacy and safety. Once the clinical trials are completed, the company may apply for New Drug Application (NDA) to see if FDA will approve the drug or not.

For medical device, the device can be categorized into different groups based on the level of the risk of the product. If a device can be proved to be as safe and effective as an existing solution, the device can be approved through 500 (k) process. This is a shorter process. The device can be classified into three categories based on level of risk. Class I – low risk group only needs to be registered with FDA. Class II – Moderate Risk group will need to be cleared through 510 (k) process. The Class III – High Risk or no predicate group will need to go through Pre-market Approval process with FDA.

Strategic Consideration for International Market

It is key for start-up companies to understand the strategic considerations of the international approval process to reduce the time to market and the cost of conducting multiple clinical trials in each intended market.

  • For new drug companies, the companies shall consider apply to be recognized as orphan drug for treating rare disease if the target population is small. The designation will provide tax credit and reduced fees.
  • The companies shall engage with FDA through pre-IND meetings to reduce the risks of rejection and address FDA concerns early in the process.
  • The companies shall build a team for clinical study early, also ensure the budget is sufficient to pass the clinical studies.
  • Certain countries provide better tax credits in the clinical study process and have less restrictions on the studies. It may be worth for start-up companies to work with multiple counties at the same time to ensure the data can be used in different countries.
  • In most of the European countries, a Qualified Person (QP) is required to examine the manufacturing facilities and process. It may take up to two years to obtain a certified QP.
  • For medical device, the company should consider the target market. It may be advantageous to start the application to multiple regulatory bodies at the same time.
  • It is possible for the company to manufacture their product through OEMS (Original Equipment Manufacturers)

For more information, you may want to explore through the following resources:

Lipsky, M. S., & Sharp, L. K. (2001). From idea to market: the drug approval process. The Journal of the American Board of Family Practice14(5), 362-367.

Batta, A., Kalra, B. S., & Khirasaria, R. (2020). Trends in FDA drug approvals over last 2 decades: An observational study. Journal of family medicine and primary care9(1), 105.

Jose, J., Pinto, J. S., Kotian, B., Thomas, A. M., & Charyulu, R. N. (2020). Comparison of the regulatory outline of ecopharmacovigilance of pharmaceuticals in Europe, USA, Japan and Australia. Science of The Total Environment709, 134815.

Faris, O., & Shuren, J. (2017). An FDA viewpoint on unique considerations for medical-device clinical trials. New England Journal of Medicine376(14), 1350-1357.