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In inquiring with the FDA, they made many of their resources available through links they provided. Links for an overviews of the FDA’s activities regarding medical devices can be found on their website. Information related to device advice, medical device safety as well as other resources are available throughout this page. Additionally, the FDA made available all the COVID-19 related guidance documents available all on one page as well. This page shows you the guidance documents most recently posted first and shows you the next 9 most recently posted documents. There are currently 53 documents that are accessible by clicking next or the page number for all the guidance documents listed towards the bottom right-hand side of the page.
The FDA also lists the information on current Emergency Use Authorizations (EUA). If additional information is needed on EUAs and its process, which includes information on situations that qualify for EUA and the general information the FDA needs to determine whether your device meets the criteria for an EUA, the FDA links the guidance document. The FDA also lists the difference between N95 respirators and facemasks by linking a page on their website that describes each in detail with images to help show the difference. The FDA makes note that if you are submitting information for a diagnostic test (IVD) to contact Covid19DX@fda.hhs.gov.
The general information on importing medical devices is listed separately. The FDA also gives a link to the U.S. Customs and Border Protection Cargo Messaging Systems (CSMS). The FDA notes that specific import information regarding certain types of medical products, including respirators, masks, ventilators, and personal protective equipment (PPE) are located within specific guidance documents and EUAs.
In case of a shortage, the FDA wants all medical device manufacturers who are reporting a device shortage by email to deviceshortages@fda.hhs.gov.
If the information on current EUAs is reviewed, the Emergency Use Authorization Guidance Document, the specific guidance documents and EUAs, you have confirmed that your product is not a diagnostic device, and you are submitting an EUA request, the FDA asks that your Non-Diagnostic EUA request be sent via email to CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov.
If you have any questions related to the FDA resources provided above or need assistance in submitting an EUA request to the FDA, please email info@mdiconsultants.com RE: Resources.