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…

Medical Device Cyber Security Plan for Software

Medical Device Cyber Security Plan for Softwarebecome 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 controls, the…

506J Notification

What is FDA’s Section 506J Notification? Section 506J notification of the FD&C Act requires manufacturers to notify the Secretary of a permanent discontinuance in the manufacture of specific devices or an interruption in the manufacture of certain devices, which leads to disruption in the supply of that device in the United States. This policy is…

Clinical Data

Pre-Clinical and Clinical Data

Pre-Clinical Vs Clinical Data Pre-clinical data are the vital testing and safety data collected during the research stage before the clinical trials begin. Tests like in-vitro tests, ex-vivo tests, biological evaluation, simulated use, engineering, performance tests, animal tests, computer modelling, lab tests, stability, shelf life etc. come under pre-clinical tests. Clinical data are used to…

MDR Classification

MDR Classification

Medical Device Classification The new MDR 2017/745, which came into effect on 26 May 2021, categorizes medical devices into classes: Class I, Class II a, class II b, and class III. This classification is based on the 22 rules in the new MDR 2017/745. Rules 1-4 for Non–invasive devices, rules 5-8 for Invasive devices, rules 9…