Full Circle Consulting
EMMA International can be there every step of the way for your product! From product development to helping with QMS upkeep and post-market monitoring, EMMA is here to bring your product full-circle. The expertise of the EMMA team can help you get through the biggest quality and regulatory hurdles in the life science industry with ease.
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Full Circle Consulting Resources
Under FDA regulations device labelers must generate a unique device identifier (UDI) for each of their products that are headed to market. This identifier will then be stored within the global unique identification database (GUDID) allowing for eased product lookup. However, certain class I and unclassified devices are not required to be a part of the GUDID. The UDI allows for eased tracking of devices that are in distribution from either human or machine-readable identifiers.
Classification of certain medical devices may be predisposed to ambiguities related to which classification type (I, II, or III) they belong too. The three FDA classification types for medical devices are: I - general control, II - special controls including general controls or III - premarket approval including general controls [1]. Proper definition of the classification in which the medical device belongs to is necessary for FDA compliance. In the case that the medical device has an indeterminate classification, a 513(g) can be exercised to request FDA guidance for its proper classification.
Complaint management systems are a necessary part of a Quality Management System. Complaint management is defined as any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution. As outlined in 21 CFR 820.198, each manufacturer maintains complaint files and has a process for receiving, reviewing, and evaluating complaints. This must be done in a timely manner and be done by a formal complaint handling unit.
The FDA divides Life science products up into different categories with their associated centers. These centers, for medical products, are Drugs, Devices, and Biologics. If a product applies to more than one of these centers, it is sent to the office of combination products which serves as the focal point for medical product classification and assignment issues.
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