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…
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…
What is UKCA Marking? The United Kingdom Conformity Assessed marking, or UKCA Marking is only legal in the United Kingdom. It was implemented in response to Brexit and went into effect on January 1, 2021. Manufacturers must adhere to the recommended UK product labeling in order for their items to be sold in Great Britain.…
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…
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…
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…
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…
EN ISO 10993-18 ( CHEMICAL CHARACTERIZATION OF MEDICAL DEVICE ) Chemical characterization is a crucial step in evaluating the biocompatibility of a medical device. It is done to identify and characterize the chemical constituents (extractable and leachable) which could disclose biological risks to patients and medical practitioners. Extractables are substances that can be…
MDR LABELLING REQUIREMENTS [A] NON-ACTIVE MEDICAL DEVICES Information on the Label Name or trade name of the device. Necessary details for a user to identify the device, the contents of the packaging, and the intended purpose of the device. The name, registered trade name or registered trademark, and the address of its registered…
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…