FDA / Regulatory News
FDA issues In Vitro Diagnostic Emergency Use Authorizations (EUA) for Coronavirus COVID-19 Diagnostic Tests
Criteria for Issuance of Emergency Use Authorizations (EUA) – During the effective period of the HHS Secretary’s EUA declaration, FDA may authorize the introduction of a medical product into interstate commerce when the product is intended for use during an actual or potential emergency (like public health emergency now). EUA candidate products include medical products and uses that are not approved, cleared, or licensed under sections 505, 510(k), and 515 of the FD&C Act or section 351 of the PHS Act.
FDA may issue an EUA only if FDA concludes that the following four statutory criteria for issuance have been met:
- Serious or Life-Threatening Disease or Condition
- Evidence of Effectiveness (lower level evidence if benefit of use is higher – next bullet point)
- Risk-Benefit Analysis
- No Alternatives
Till March 19, 2020 11 IVD tests got EUA.
FDA is postponing all domestic routine inspections
FDA typically performs routine inspections of domestic manufacturers of medical devices and other products every few years, with the exact schedule being determined by a risk analysis
In absence of routine inspections, FDA Commissioner Stephen Hahn said the agency is looking into ways to conduct inspection work that do not put agency staff, the companies they visit and the public at risk.
“This can include, among other things, evaluating records in lieu of conducting an onsite inspection on an interim basis when travel is not permissible, when appropriate,” Hahn said in a statement.
Cybersecurity
Cyber Attack Hits Department of Health and Human Services
A cyber-attack hit the Department of Health and Human Services on March 15 that aimed to undermine the efforts of the agency to respond to the COVID-19 pandemic.
The incident involved a DDos (distributed denial of service) attack that does not qualify as a full breach. The agency’s servers were hit with millions of pageviews that are meant to slow the site down or bring it offline entirely. HHS officials said no personal data was accessed and the attack was not successful.
