The new article highlights certain specific aspects pertaining to the regulatory framework, emphasizing the key points to be taken into consideration.
Table of content
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance document dedicated to the enforcement policy for certain in vitro diagnostic devices for immediate public health response in the absence of a declaration under Section 564. Once finalized, the document will provide an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, it is important to mention that the document is non-binding in its legal nature, nor is it intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legal framework and has been agreed with the authority in advance.
Test Manufacturers
This policy pertains to immediate response tests designed, manufactured, and utilized within a single laboratory that is certified under the Clinical Laboratory Improvement Amendments (CLIA) and meets the criteria for performing high complexity testing. The laboratory must have demonstrated the ability to develop a similar diagnostic test consistent with FDA regulatory requirements and must be free of any current compliance concerns communicated by the FDA.
Eligible laboratories include:
- United States Government (USG) laboratories
- State or local public health laboratories
- Laboratories operating under an agreement (formal or informal) with the USG
Alternatively, the policy applies to tests designed, manufactured, and distributed by the Centers for Disease Control and Prevention (CDC) for use by CLIA-certified laboratories qualified for high complexity testing.
Such laboratories must be:
- Within the CDC
- Part of the CDC’s Laboratory Response Network (LRN)
- Operating under an agreement with the CDC
Test Validation
According to the guidance, immediate response tests must be validated on the systems (including instruments and reagents) intended for clinical use. For instance, for a PCR-based test for infectious diseases, the FDA recommends completing the following validation studies before testing and making summary validation and performance information publicly available:
- Clinical evaluation of at least 30 positive and 30 negative clinical samples; if these are unavailable, synthetic (contrived) specimens using unique negative patient samples may be used.
- Limit of detection (analytical sensitivity).
- Inclusivity (analytical reactivity).
- Cross-reactivity (analytical specificity).
It is also important to mention that the FDA is available to discuss validation approaches with laboratory manufacturers in specific circumstances. Where the need for an immediate response test can be anticipated, pre-EUA submissions for a preliminary review of available validation information are encouraged.
Laboratory manufacturers should concurrently perform additional validation studies, preparing for an EUA request if an applicable 564 declaration is issued. Clinical evaluations should be repeated with natural clinical specimens when feasible.
If not feasible before requesting an EUA, the FDA may require such a study as a condition of authorization.
Notification to FDA of Test Offering
The relevant regulatory requirements also provide that laboratories must notify the FDA prior to or concurrent with the initiation of testing by emailing CDRH-EUA-Templates@fda.hhs.gov with the subject line “Notification of Immediate Response Test”.
The notification should include:
- The serious or life-threatening disease or condition the test is intended to detect or diagnose and the rationale for its use under the current circumstances.
- Contact details including name, address, phone number, and email.
- General laboratory information including the name and address of the laboratory manufacturer, the laboratory director’s name, and the CLIA ID number.
- General test information including the test name, methodology (including specimen type), the testing start date, and the estimated testing capacity.
- A statement describing the laboratory manufacturer’s regulatory and compliance standing (e.g., any recent warning letters).
- A list of other similar tests developed by the laboratory manufacturer that have been approved, cleared, or authorized.
- A link to where summary information on the test will be publicly available.
When a laboratory manufacturer stops offering a test previously offered under this policy, they should notify the FDA by emailing CDRH-EUA-Templates@fda.hhs.gov with the subject line “Discontinuation of Immediate Response Test Offering”.
Transparency
To ensure transparency, test reports and ordering information should prominently disclose that the test was manufactured for use as part of an immediate public health response during an emergent situation to detect or diagnose a disease or condition attributed to a CBRN agent. This disclosure should specify that the test has not been reviewed or authorized by the FDA.
Any statements implying FDA review or authorization, or suggesting imminent or pending authorization, would be false or misleading, thereby misbranding the test. Since these tests will not have undergone FDA review or authorization, laboratory manufacturers should make summary validation and performance information publicly available.
If a manufacturer believes that posting this information could risk national security or be otherwise inappropriate, they should contact the FDA for discussion. Laboratories must immediately notify appropriate Federal, State, or local public health agencies of test results as required by applicable laws.
Conclusion
In summary, the present enforcement policy introduced by the FDA establishes a special framework facilitating the availability of certain in vitro diagnostic devices intended to be used in the context of outbreaks of diseases considered to be significant in terms of public health protection.
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