Recognized consensus standards

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…

Cyber Security Plan for Software as Medical Device

Cyber Security Plan for Software as Medical Device(SaMD) become more competent in accessing, analyzing, communicating, and automation to improve the speed and quality of patient care. However, advancements with technological advances arise new risks and concerns. The risk of threats in both network and software is unavoidable through hackers. To assist manufacturers in developing adequate…

510K Vs PMA

510k Vs PMA

Premarket Notification Vs Premarket Approval [ 510k Vs PMA ] Class II medical devices require a 510k submission (premarket notification), while Class III medical devices require a PMA (premarket approval), but what is the difference in the process between the two? A PMA is a more detailed document than a 510k. PMA is used to…