The Food and Drug Administration's (FDA) oversight on food and drugs began in 1906, and it is the oldest consumer protection agency in the United States. However, there was no oversight for medical devices until 1976 when the Medical Device Amendments to the Food, Drug and Cosmetics (FD&C) Act put many of the same types of requirements already in place for drugs onto medical devices.
Medical device manufacturers were then required to provide reasonable assurance of safety and efficacy. Risk classification and regulatory pathways were identified, post-market requirements were put into place and registration requirements for the device listing was created. The FDA was also authorized to ban devices that did not meet the requirements. In 1982, the Center for Devices and Radiological Health (CDRH) was created to provide a dedicated arm of the FDA to regulate and oversee medical devices.
Medical Devices Regulated by the FDA
The development of life-saving medical devices is quickly changing as new technology such as 3D printing, software, hardware and algorithms are incorporated into device designs. Constructing medical devices requires sophisticated designs that help people improve or save their quality of life. Some examples include 3D-printed spinal implants, implants that can help blind people see, and lead-free pacemakers which utilize hardware, software and Bluetooth technology. And, there are always new devices coming to the market with new technology being presented for review.
In the USA, the FDA categorizes these various and ever-changing lists of medical devices by risk. FDA Class I, II and III devices each require different regulatory strategies in order for them to be approved for market. The approval to market granted by FDA is based on the device’s safety and efficacy and reasonable proof that the benefit of the device outweighs any risks or side effects.
Just as each device is unique, each device regulatory path is unique. There are classifications based on risk, regulations based on product code, recognized consensus standards by device, and targeted guidance documents based on the FDA's guidance following specific device use. There are also different types of submissions/requirements based on risk class. For instance, a surgical suture has a different submission and requirements, guidance(s) and standards than a pacemaker or an AI System. In addition, there are a host of other recognized consensus standards that apply to many devices across the board. An example of this is sterilization standards. Regardless of what your device is, if it is provided sterile or is sterilized on-site, applicable sterilization standards must be followed. It is important for your regulatory professional to be able to identify all standards applicable to your device as early as possible in the design process so that proper testing and validation can be performed once, correctly.
Health and Human Service (HHS) Department Regulations
On February 4, 2020, the Health and Human Service (HHS) Department declared that the United States was in a state of emergency due to the COVID-19 pandemic. This designation allowed the U.S. to utilize the Emergency Use Authorization (EUA), which has been in place since 2009 and was previously used during the H1N1 outbreak. In 2009, the EUA was used to obtain expanded indications of the drug Tamiflu for broader use to combat H1N1. In the case of COVID-19, the EUA was allowed to include everything needed to battle the pandemic: drugs, biologics and devices.
Any legal manufacturer already holding an FDA-issued market approval could ramp up production and market or distribute their device so long as its indications weren’t changed. As an example, surgical face masks have been approved for market by the FDA since 1977. A surgical mask is a Class II device and requires a 510(k) submission for standard approval. For this device there are three required recognized consensus standards that must be followed in order for the mask to be approved by the FDA to market as a medical device. These standards document a test method which must be followed, a materials performance standard, and a test method for evaluating bacterial filtration efficacy. Any manufacturer with an approved 510(k) can begin to distribute products immediately.
However, during the COVID-19 pandemic, there was an increased need for many medical products, including personal protection equipment (PPE). There was a huge shortage in PPE for doctors and nurses which was necessary for their safety when caring for COVID-19 patients. Even with the amount of already approved devices being sold, we didn’t have enough of what we needed, which drove the need for an EUA.
The Difference Between FDA Market Approval and EUA Approval
For a standard 510k submission, the legal manufacturer is required to complete the FDA-required forms. Once compiled, and fees paid, submissions are delivered to the FDA for a 90-day review. If the FDA had questions around the information presented, approval could follow the 90-day period.
For an EUA submission, the FDA created templates for medical devices to ensure they were receiving information that would allow them to assess safety and efficacy. In the case of masks and other medical devices, the legal manufacturer still had to prove they met the requirements of the FDA recognized consensus standards.
The first EUA approval for surgical masks was issued on August 8, 2020. A total of 50 manufacturers submitted EUAs for surgical masks with the most recent EUA approval issued on March 4, 2022. The EUA helped ensure the country had access to the needed surgical masks without compromising safety or efficacy by paring down the submission.
U.S. Emergency Use Authorizations
Emergency designations are in place across the United States until the HHS formally declares a situation complete. This means any company can obtain an EUA approval, if they are meeting safety and efficacy requirements, at any time before the emergency is declared over. When the emergency is declared over, any manufacturer that was approved under the EUA system but did not follow up with a “normal” 510k submission and approval will need to remove their device from market. Manufacturers who received EUA approval and then wrote a 510k submission according to FDA guidance documents and submitted it for review and approval to market will be able to keep selling their product after the emergency is declared over.
Conclusion: FDA and EUA Approvals in the United States
While no one could have predicted the global pandemic, the United States was fortunate that the country had an existing system in place to regulate device quality as demand increased. Many countries did not have enough professionals to navigate EUA regulations while juggling more standard non-pandemic related device approvals.
