Throwback 2016
Regulatory Guidelines for the Pharma Industry, so far in ‘16
In an ever changing world of Life Sciences regulations, the Pharma industry has seen many new mandatory requirements from the health authorities worldwide.
In an ever changing world of Life Sciences regulations, the Pharma industry has seen many new mandatory requirements from the health authorities worldwide.
The influence on Medical Device’s Regulatory Decision Making
Centre for Devices and Radiological Health (CDRH), a division of US Food and Drug Administration (FDA) seems to be all set to enhance the quality of Medical Devices and Radiation-emitting products in order to ensure the patient safety. Emphasizing the same, Regulatory science at CDRH has released a set of priorities for FY 2017 stressing more on modernization availing Big Data and real-world evidence.
What is Regulatory Science?
September 24th 2016; with the deadline, just a month away for Class II device Unique Device Identifier (UDI) compliance, it is our assumption, if not for sure, that all medical device manufacturers are well equipped with a comprehensive Regulatory roadmap. Besides having a firm grip over governance pre-requisites, manufacturers are expected to be audit ready for the compliance. Right from validating Device Identifier (DI) and Product Identifier (PI) records to successful GUDID submissions, they are ought to be knowledgeable on the data to be submitted and procedures to be followed.
Ever evolving Regulatory landscape, healthcare system reforms, and on-going technological advancements: with these factors influencing regulatory procedures at the most, the biggest task for life sciences organizations is to reduce the operational costs while managing the procedural efficiency for end-to-end compliance. The involved costs, per say, could be of the Regulatory workforce, facilities, and other hidden operational burdens.
With compliance deadline for non-class III implantable, life-supporting, and life-sustaining (I/LS/LS) devices finished recently, the FDA’s Center for Devices and Radiological Health (CDRH) has summarized the Unique Device Identifier (UDI) compliance date for Class II devices i.e., on September 24, 2016.
The US FDA finalizes post-market surveillance guidance
After a prolonged duration of 18 years, IVD (In vitro Diagnostic) Medical Devices finally fall under the purview of Health Canada’s much awaited finalized labeling guidance. The first draft of this guidance was issued in the year 1998. This guidance emphasizes mainly on:
Heads-up: Class II Device’s Unique Device Identifier (UDI) Compliance is here. As part of the phased approach to UDIs, the US Food and Drug Authority (FDA) has mandated manufacturers of Class II devices to get complied by Sep 24 2016. The upcoming mandate is succeeding the Class III (Implanted) devices’ compliance in 2015 and preceding the Class I devices’ compliance scheduled in 2018.
Medical device’s global standard for quality management system gets a long-awaited amendment to a new standard: ISO 13485. However, the new amendment allows the manufacturers, regulators, certification bodies a time window of three years for the transition process. Till then the previous standards ISO 13485:2003 and ISO 13485:2016 will coexist.
Now that the second phase of UDI compliance, for Class III I/LS/LS medical devices, has been implemented, many device manufacturers, especially of Class II type, are questioning how best they could be prepared for September 24, 2016 Class II device data submission deadline. To give them heads up, at Freyr, we have identified some of the prerequisites they should consider to line up Class II devices for compliance with FDA’s UDI mandate.