The Food and Drug Administration is the oldest consumer protection agency in the United States. The FDA's oversight on food and drugs began in 1906. However, there was no oversight for medical devices until 1976. The Medical Device Amendments to the Food, Drug and Cosmetics (FD&C) Act, put many of the same types of requirements that were already in place for drugs onto medical devices.
Medical device manufacturers were now required to provide a reasonable assurance of safety and efficacy, a risk classification was created, regulatory pathways were identified, a regulatory pathway for new investigational devices was unveiled, post-market requirements were put into place and registration requirements for the establishment and a device listing was created. The FDA was also authorized to ban devices that did not meet the requirements. Finally in 1982, The Center for Devices and Radiological Health (CDRH) was created so there was a dedicated arm of the FDA to regulate and oversee medical devices.
Medical Devices are Now Regulated
Medical devices have been saving lives for decades. And medical devices are quickly changing as new technology such as 3D printing, software, hardware and algorithms are being incorporated into device designs. Medical devices are not simply band aids and thermometers any longer. They are sophisticated designs that help people with a myriad of problems and in many cases, they prolong and save lives. There are 3D printed spinal implants, implants that can help blind people see, heart pumps in suitcases that can help a person live until transplant is available and leadless pacemakers which utilize hardware, software and Bluetooth technology. And, there are always new devices with new technology being presented for review.
In the USA, FDA categorizes these various and ever-changing lists of medical devices by risk. FDA Class 1, 2 and 3 devices all 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 FDA's lessons learned and new information that often comes to light after a period of 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.
A Regulatory Path We Hope not to See Again
On February 4, 2020, the Health and Human Service (HHS) Department declared the USA was in a state of emergency due to the COVID-19 pandemic. This designation is important because it allowed the USA to utilize the Emergency Use Authorization (EUA) which has been in place since 2009 and was used previously during the H1N1 outbreak. In 2009, the EUA was used to obtain expanded indications of the drug Tamaflu for broader use to combat H1N1. In the case of COVID-19, the EUA was allowed to include everything we needed to battle the pandemic: drugs, biologics and devices.
Any legal manufacturer already holding a market approval issued by the FDA could ramp up production and market / distribute their device during the pandemic (or any other time) as long as it’s 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 2 device and requires a 510(k) submission for “normal” approval. For this device there are three (3) required recognized consensus standards that MUST be followed in order for the mask to be approved, by 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) could ramp us and distribute items immediately.
However, during the COVID-19 pandemic, there was greater need for many things 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 all of the already approved devices being sold, we didn’t have enough of what we needed. So, we needed to utilize the EUA.
The Difference Between ‘Normal” Market Approval and EUA Approval
For a “normal” submission (i.e., 510k) the legal manufacturer is required to write en entire submission which includes completion of FDA required forms and designated sections. Once compiled, and fees paid, the submission could be saved onto a USB, validated, and mailed to the FDA for a 90 day review. If there were questions on the information presented approval could come weeks or months later than 90 days.
For an EUA submission, FDA created templates for medical devices to ensure they were receiving information that would allow them to assess safety and efficacy. This submission could be submitted to a dedicated team of reviewers via e-mail and review and approval was happening within weeks if the standards were followed and criteria was met. 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.
Taking the example of surgical masks again, 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 we had the surgical masks we needed without compromising safety or efficacy by paring down the submission to only what was needed to support safety and efficacy and having a dedicated review team. New manufacturers still needed to comply with applicable standards and guidance(s).
What Happens Next
In the US, the emergency designation is in place until the HHS formally states it is over. That means that any company can get 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.
Nothing is perfect and no one could have predicted that a global pandemic was on the horizon. However, we have been very fortunate here in the US. Many countries did not have any system in place to deal with higher demand for these products or to ensure the devices quality. Many countries also did not have enough regulatory professionals to navigate the regulations, write and submit the EUAs all while juggling other “normal” non-pandemic related device approvals. I’m so proud of my fellow regulatory professionals. We have been busy! Hopefully, this will end soon and we won’t have to do this again. But it is comforting to know…WE CAN.