For IVD manufacturers, the emergence of a novel virus is challenging as the detection of such viruses require quickly developed, novel diagnostic solutions.

However, existing regulations in place to protect the public’s health and safety can impede the rapid development and deployment of novel IVD tests.

As a result, regulatory agencies across the world are adapting guidelines while COVID-19 remains an active pandemic. Continuous coordination with industry stakeholders will enable the quick and effective development of new and effective diagnostics. Some government bodies are advising developers to initiate communications with government agencies early on, allowing regulatory experts to help review data on a rolling basis for fast track development and market access. 

Also, establishing guidance and adherence, will create transparency, which is required to mitigate potential adverse events from poorly designed tests and facilitate more informed decisions by potential buyers and users. Ultimately, ensuring proper validation is integral to the health and safety of patients and the clinical utility of the diagnostic. 

Due to the revisions and modifications regulatory agencies are making to current guidelines and policies to enable the much needed diagnostic response, more than 40 COVID-19 diagnostics globally have launched over the past couple of months. In this blog, we provide an overview of regulatory changes occurring in diagnostics amid COVID-19.

Shifting regulations within the U.S.

In an effort to expedite the availability of diagnostic tests in the United States, the U.S. Department of Health and Human Services declared authorisation of emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the coronavirus in early February. Following this announcement, the FDA issued a guidance describing policies for laboratories and commercial manufacturers, to expedite the availability of IVDs. This guidance included revised testing recommendations to ensure analytical and clinical validity expeditiously, in addition to providing templates required for emergency use authorisation (EUA) submissions. 

Further, the FDA’s guidance allows distribution of validated tests prior to EUA submission, but the information for use (protocol) is not released to the public until the EUA is granted. Specifically, the FDA notes that 15 business days is a reasonable amount of time for manufacturers to prepare and submit an EUA. However, this policy does not apply to at-home tests.

Adapting current regulations in Europe

The World Health Organization (WHO) classified the COVID-19 outbreak as a public health emergency of international concern in January. WHO Emergency Use Listing (EUL) procedure is a way to evaluate IVDs in development that can address the COVID-19 outbreak. The WHO has continuously stressed the need for IVDs for screening and diagnosis, and aims to expedite the availability of IVDs. Additionally, the organisation published validation requirements for IVDs based on the detection of specific nucleic acid. 

In early April, the European Commission issued a guidance, which includes in vitro diagnostic medical devices, specific to the pandemic, summarising harmonised standards, derogation procedures, and the recent proposal to postpone the application date of the European Union Medical Devices Regulation by one year. Under the current IVD Directive, the majority of IVD devices are self-certified by manufactures for conformance. Therefore, if an assay meets the specific classification requirements outlined in the IVD Directive, it does not require an independent assessment of conformity by a notified body to be CE marked. 

Evolving diagnostic regulations in APAC region

At the onset of the outbreak, South Korea’s Centers for Disease Control and Prevention quickly coordinated with manufacturers to develop and ensure regulatory approval of the first diagnostic. Upon evaluation by government and medical academic experts, this diagnostic was granted emergency use authorisation by the Ministry of Food and Drug Safety and applied swiftly across the country. 

Many countries within the Asia-Pacific region — including Singapore and Australia — soon followed suit, relaxing regulatory guidelines to address the overwhelming diagnostic testing needs caused by COVID-19. In addition, in February, China’s Center for Medical Device Evaluation (CMDE) announced adjustments to its medical device application acceptance and consultation services to expedite review and approval. The CMDE published two new guidelines on nucleic acid detection reagents and antigen/antibody detection reagents designed for IVDs in the detection of the coronavirus.

Partnering with diagnostics experts

Manufacturers operating with effective quality measures and the ability to create validated assays will be better positioned for efficient and positive assessment by regulatory agencies. At ICON, our diagnostics team can assist in navigating validation and the evolving regulatory landscape. Contact us to speak with our experts today.

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