Daily Archives: July 24, 2022

Financial Certification or Disclosure Statement for FDA

Financial Certification or Disclosure Statement for FDA Financial Certification or Disclosure Statement is one of the sections of 510(k) submission that mentions a single statement like “This section is not applicable as no clinical studies were performed to test this device” if no clinical studies are performed. If performed clinical studies on the device the FDA…

Standards, Recognized consensus standards, and Guidance in FDA

Differences between Standards, Recognized consensus standards, and Guidance   Standards Recognized consensus standards Guidance A standard is a repeatable, harmonized, agreed, and documented way of doing something. It is a database that provides the most up-to-date list of voluntary consensus standards to which the FDA will accept a Declaration of Conformity. Guidance documents represent FDA’s current thinking…