Monkeypox Testing – U.S Pathways to Licensing

Monkeypox Testing – U.S Pathways to Licensing

November 3, 2022 By

Monkeypox, the disease caused by the animal-to-human transmission of the Monkeypox virus, is a zoonosis of the Orthopoxvirus genus within the Poxviridae family. Usually endemic to regions of central and west Africa, Monkeypox is being diagnosed in more and more urban areas. This demonstrates that human-to-human transmission is increasingly common, primarily through close contact with an infected person, including respiratory secretions, skin lesions, and contaminated materials.

The importance of early detection and monitoring was learned from the COVID-19 pandemic. Monkeypox was declared a “public health emergency” or “had significant potential for a public health emergency” on August 4, 2022, by the Secretary of the Department of Health and Human Services (HHS), allowing the FDA to issue Emergency Use Authorizations (EUAs) to allow the use of unapproved in vitro diagnostics or unapproved uses of approved in vitro diagnostics for the detection and/or diagnosis of infection with the monkeypox virus, as well as non-variola Orthopoxvirus.

However, this authorization does not apply to at-home tests, tests with home specimen collection, and tests performed outside of a high-complexity CLIA-certified laboratory. Therefore, if you wish to market a Monkeypox testing kit, you will first need to classify your testing kit as Class I, Class II, or Class III. These classifications represent risk categories and therefore considerations that need to be taken with them before marketing the products:

  • Class I: lowest risk category, for low to medium-risk products
  • Class II: medium to high-risk products, which may require additional considerations
  • Class III: high-risk products that also require a pre-market approval

Once your classification has been determined, it is time to determine whether you will need to go through one of the following conventional medical device pathways:

510(k) – Pathway for predicate device already on the market

The 510(k) pathway is for medical devices that already have a predicate (similar) device on the market. This allows for a precedent to demonstrate that the device is safe and will function as intended. Upon proper classification of the testing kit, you will then need to notify FDA of your intent to market a medical device at least 90 days in advance. This is known as Premarket Notification. It is important to classify your device correctly before submitting a 510(k): while most Class I and a large number of Class II products can be exempt from pre-market notification, this classification may get changed depending on the importance placed on the device (such as increased need due to a health emergency).

De Novo Pathway if there is no predicate (lower risk)

If your in-vitro diagnostic device (IVD) is considered lower risk, and there is no predicate device currently on the market, then this would be your pathway. Devices classified as Class I or Class II through this pathway may be marketed and used as predicates for future 510(k) submissions, when applicable. Data to support this type of application includes relevant clinical data and non-clinical data to support a reasonable assurance of the device’s safety and effectiveness should be provided, along with quality information (such as sterilization, shelf-life, biocompatibility, etc), and a risk/benefit description when the device is used as intended. Reviews of De Novo requests can take up to 150 calendar days from the date the application was received.

PMAA – Premarket Authorization Approval (not necessarily new, but high risk)

Premarket Authorizations are intended for products that are high-risk. This includes: supporting or sustaining human life, important in preventing impairment of human health, or for which there is a potential/unreasonable risk of illness or injury from its use. These products are always considered Class III, whether or not there is a predicate on the market; however, many Class III products also involve new concepts that require much more stringent examination to ensure that they are safe and effective for use.
PMA applications must provide extensive information relating to the technical aspects of the product, grouped into non-clinical lab tests and clinical investigations.

Lastly, due to the need to stay ahead of virus mutations and continuously improve detection and testing technology, existing devices may be reviewed for improvement or new uses, and new devices will continue to emerge. In order to ensure that risks are minimized for the general public, a device may apply for an Investigational Device Exemption (IDE). This involves a medical device being assessed for safety or performance in a clinical investigation and includes existing devices being evaluated for new intended uses, new populations, new materials or design changes. Clinical studies are commonly used to support PMA applications, and therefore will need to be done prior to the submission of a PMA application. The approved exemption must be obtained prior to the clinical study being initiated.

dicentra can assist you with all aspects of bringing your Monkeypox testing device to the U.S market. Contact us today for guidance, development, and implementation of your application or clinical trial.

Read our previous blog on Monkeypox Testing – Canadian Pathways to Licensing for information on monkeypox test licensing in Canada.