Label maintenance and updating is the process of ensuring that the data on the label stays up-to-date and accurate throughout the life cycle of the device. This could entail updating information to meet new laws or standards, amending the existing labels to reflect changes in the product or its intended use, or fixing typographical errors.
Labeling is an integral part of marketing medical devices. The label is a piece of information affixed with the device and/or packaging in a human-readable format. The main purpose of labeling is to provide safety information to users who can be healthcare professionals, consumers, or any other relevant person.
The FDA’s CDRH (Center for Devices and Radiological Health) has published a list of medical devices guidance documents for the fiscal year 2022. This list of guidance documents conveys a degree of transparency (in terms of where the regulator plans to commit resources and potentially increase scrutiny over the coming year and how manufacturers may be impacted in terms of compliance) for the medical device applicants and registrants who are willing to enter the USA market.
The FDA CDRH has divided its list of guidance documents into three (03) sections:
With the evolution of technology, the healthcare industry has become keen on integrating software with medical devices to incorporate automation and accuracy in the prediction, diagnosis, prevention, treatment, and management of health conditions. The US FDA had long recognized the role software can play to benefit the functioning of medical devices but was yet to come up with any concrete guidance or rules that could have facilitated the industry researchers in making advancements towards digital health.
Design of logical Instructions for Use (IFU) and Operation Manual of medical devices requires an efficient, structured, and organized approach. It is critical for ensuring a medical device user’s safety and comprehension, as IFU and manuals are used to inform the end-user how to use the device. Modern medicine is extremely techy, and the quality of IFU, as well as operation manuals, are expected to be high as it may impact human well-being and lives.
It is well known that the mandatory deadline for European Medical Device Regulation (EU MDR) was postponed to May 26, 2021, due to abrupt onset of COVID-19. In simple terms, the EU MDR aims to provide device clinical safety and effectiveness by establishing a robust, transparent and sustainable Regulatory framework that is recognized internationally and improves fair market access for manufacturers.
The Conformity Assessment Body (CAB) carries out the conformity assessment of various stakeholders of medical device supply chain system. The Conformity Assessment Body (CAB), Malaysia carries out extensive audits and evaluates all the applicable elements set by the Medical Device Authority (MDA), Malaysia and verifies the device conformity to the relevant standards.
In recent times, the use of AI/ML (Artificial Intelligence/Machine Learning) has taken a huge technological sweep in the medical devices and healthcare industries because of their ability to diagnose, manage and treat a wide variety of medical conditions and to enhance the patient care. But there seem to be obstacles in implementing AI/ML in daily practices, with respect to the transparency issues surrounding their software programs. Hence, it is crucial to regulate these technologies and to do so, the Regulatory bodies are effortlessly trying hard to govern the AI/ML implementation.
Health Canada has clarified its stand on the research use only testing kits related to COVID-19. Health Canada regulates the import and sale of medical devices and IVDs (In-vitro Diagnostic Devices) in the Canadian market. In the event of the ongoing COVID-19 pandemic and to facilitate the supply of essential medical devices and IVDs, Health Canada has released various Interim Orders for the manufacturers, importers and distributors.
Since the onset of Coronavirus Disease 2019 (COVID-19), Health and Human Services (HHS) has declared a Public Health Emergency. The US FDA, since then, has been releasing various enforcement policies to ensure continued supply of certain essential medical devices, which play a vital role in prevention, diagnosis, management and treatment of COVID-19 and associated co-morbidities. A new enforcement policy has been released by the US FDA to facilitate the increased supply of coagulation systems used for assessing the viscoelastic properties of whole blood and the hemostasis in patients.
