June 29, 2022
Companies, FDA caught unaware by surge in virus cases, leading to shortage of critical items.
From adhesive bandages to heart monitors, medical devices are all around us. Some of these are easily accessible in stores, whereas others are exclusive to clinics and hospitals. How is it possible to determine which medical devices are effective and safe for use with patients?
The current process for approving medical devices is administered by the FDA. The FDA oversees the premarket audit, clearance, and approval process by sorting the medical devices into 3 classes based on risk level. Traditionally, this process has been effective and efficient enough. However, with the COVID-19 outbreak, there have been issues with delays and shortages of vital medical devices, such as testing kits and ventilators.
In 1938, Congress passed the Federal Food, Drug, and Cosmetic Act to allow the FDA to gain more authority in regulating drugs and food. In 1976, the Medical Device Amendments gave the FDA the ability to oversee premarket and postmarket approval processes for medical devices.1 This process involves sorting medical devices into 3 different classes. Class I is general controls and can be with or without exemptions. This class contains medical devices that pose the lowest risk. Class II is general controls and special controls and can also be with or without exemptions. Finally, class III is general controls and premarket approval. Depending on the class categorization, the manufacturer of the medical device may be required to submit certain paperwork, such as a 510(k) or a postmarket approval application.
“A 510(k) is a premarket submission made to [the] FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device. Firms making submissions must compare their device [with] 1 or more similar legally marketed devices and make and support their substantial equivalence claims,” according to the FDA.2,3
Completing this process is expensive and time-consuming. It is estimated that for manufacturers who had to fill out the premarket approval (PMA) applicaton, usually for class III devices, they were required to “submit all available scientific knowledge concerning investigations; clinical and nonclinical data of the device’s safety and effectiveness; detailed information regarding its design, components, ingredients, properties, and principles of operation; any applicable performance standards; and other information deemed relevant by the FDA,” according to an article in the University of Michigan Journal of Law Reform.1
On top of that, the FDA is allowed to request more information from the manufacturer. Megan Andersen, writing in the University of Michigan Journal of Law Reform, goes further to draw evidence from a 2010 study regarding the costs incurred to go through the medical device approval process, specifically with a PMA.
“According to a 2010 independent analysis, ‘the average total cost from concept to approval was approximately $94 million’ for PMAs, with $75 million spent on clinical stages required by the FDA application process. The same study showed that from first communication with the FDA, it took an average of 54 months for FDA reviewers to make a determination on the device,” she wrote.1
With the FDA taking many years to review medical devices, the process can get backed up, making it less efficient to get more medical devices out there. This ties in with the recent COVID-19 pandemic. Medical device companies and the FDA were unprepared for the sudden surge in virus cases, leading to a shortage in medical devices, such as ventilators. “There’s currently thought to be a global shortage of thousands of ventilators as the world attempts to tackle the deadly pandemic,” according to Shrinidh Joshi, PhD, a freelance writer with over 10 years of experience in pharmaceutical and other medical writing.4
In addition, there have been delays in being able to obtain data on the effectiveness of a product. “Medical device manufacturers rely heavily on health care facilities for their clinical trial data collection…As the COVID-19 pandemic continues to unfold, medical device companies are finding it difficult to make informed decisions about their products, supply chains, and regulatory obligations in the midst of uncertainty,” Joshi wrote.4
The medical device approval process is a huge job left in the hands of 1 organization. Streamlining the process makes things simpler. There are plans within the Senate to fund the FDA with an additional $200 million. “The bill focuses on increases for food safety and medical product safety activities of the agency,” according to the United States Senate Committee on Appropriations.5
It is yet to be determined how much will go toward medical devices and whether it will even be effective. However, if there is going to be anything done about the huge backup in medical device approval, then Congress must enact this bill. The pandemic has resulted in mass struggle for the world and has especially affected the medical field. Hospitals are crammed, and there are shortages of important devices, not to mention delays in approving medical devices, which was a problem even before the pandemic. It is time for Congress to act.
About The Authors
Melissa A. Klonowski is a biology major at the University of Kentucky College of Arts and Sciences in Lexington.
Joseph L. Fink III, JD, DSC (HON), BSPharm, FAPhA, is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Professor of Leadership at the University of Kentucky College of Pharmacy in Lexington.
1. Andersen MC. 21st Century Cures Act: the problem with pre-emption in light of deregulation. Univ of Mich J of Law Reform. 2019;52(3):801-828. doi:10.36646/mjlr.52.3.century
2. Registration of producers of drugs or devices, 21 USC §360(2011). Accessed May 13, 2022. https://www.govinfo.gov/content/pkg/ USCODE-2011-title21/pdf/USCODE-2011-title21-chap9-subchapV-partA-sec360.pdf
3. Premarket notification 510(k). FDA. March 13, 2020. Accessed May 13, 2022. https://www.fda.gov/medical-devices/ premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k
4. Joshi S. The impact of COVID-19 on the medical device industry. Medgadget. June 15, 2020. Accessed May 13, 2022. https://www.medgadget.com/2020/06/the-impact-of-covid-19-on-the-medical-device-industry.html
5. Summary: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2022. United States Senate Committee on Appropriations. News release. United States Senate Committee on Appropriations; August 2, 2021. Accessed May 13, 2022. https://www.appropriations.senate.gov/news/majority/summary-agriculture-rural-development-food-and-drug-administration-and-related-agencies-appropriations-act-2022