China3D printingNet, October 12, the U.S. Food and Drug Administration (FDA) has updated its Frequently Asked Questions (FAQ) about COVID-19 diagnostic equipment (including3D printingSwab) information.
The government ultimately intends to refuse to review the emergency use authorization (EUA) requirements for laboratory-developed tests (LDT). The statement was issued by the U.S. Department of Health and Human Services, stating that the new LDT will not be released after pre-market review.
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Nasal swab” alt=”University of South Florida Health
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University of South Florida Health (University of South Florida Health)3D printingNasal swab. Picture from USF Health.
Enhancing U.S. testing capabilities
Although the FDA will no longer accept the EUA for LDT, it will continue to review the requirements for point-of-care testing, home collection testing, and any other testing that can alleviate national shortages. This includes high-throughput, widely distributed testing because the government wants to improve the country’s overall testing capabilities and accessibility.
The FDA stated: “Compared with the current tests, we are currently at a different stage of the pandemic. Many previous COVID-19 tests have been approved in the laboratory. We will prioritize various factors and review the EUA’s test requirements. These include factors discussed in the emergency use authorization of medical products and relevant agency guidelines, such as the public health needs of the product and the availability of the product.”
3D printingSwab update
In the new FAQ, the FDA has suggested the types of samples that can be swab tested. For now, this includes specimens of the nasopharynx, oropharynx, middle turbinate, and anterior nostril. The government has also provided guidance on the correct method of collecting these specimens, as poor wiping techniques may result in insufficient samples and injuries.
for3D printingCotton swabs (belonging to Class I medical equipment), the new guidelines point out that sterile cotton swabs that do not require pre-sale notice will be distributed without EUA. However, all facilities that manufacture these sterile swabs must register and list their additively manufactured products. The swab must also meet any applicable medical device regulatory requirements, such as those related to the quality system and correction reports.
The FDA added: “Generally speaking,3D printingIt will bring some challenges that traditional manufacturing does not have. The FDA is aware that some users have reported3D printingThe cotton swab breaks into multiple sharp pieces and concerns about unconventional capture geometries that may not adequately capture the sample.Although the FDA and the clinical community have extensive experience in the use of traditional swabs, they have previously used3D printingThere is limited experience with swabs for specimen collection for diagnostic testing. “
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Nasal swab “alt=” printed by PrintParts, New York City Department of Services
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Printed by PrintParts, New York City Department of Service3D printingNasal swab. Photographed by PostProcess Technologies.
Before the FDA update, the global certification company TÜVSÜD provided a set of3D printingList of standards and regulations. Consistent with the FDA, the checklist is designed to ensure that products comply with strict quality requirements and laws and regulations that medical devices usually comply with.
In other places,3D printingThe service bureau PrintParts recently partnered with PostProcess Technologies, a developer of post-processing systems, to additively manufacture nasal swabs in New York City. Specifically, these parts are designed to collect nasopharyngeal specimens and are made of translucent photosensitive polymer resin.
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