Bringing a Medical Device to the U.S. Market via the 510(k) Pathway
Katajamäki, Veli-Matti (2022)
2022
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Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:amk-2022062219080
https://urn.fi/URN:NBN:fi:amk-2022062219080
Tiivistelmä
Before entering the United States market, medical devices must meet related regulatory and quality requirements. There are several premarket submission procedures, and one of them is a 510(k) submission.
This thesis focuses on requirements related to the 510(k) process and interpreted them from the manufacturer's point of view. In addition, it also addresses Food and Drug Administration's (FDA) Quality System Regulation (QSR) requirements that concern the device manufacturing stage (Production and Process Controls & Acceptance Activities). Consequently, this thesis aims to provide information on the 510(k) pathway and relevant QSR requirements to a manufacturer wishing to market its medical device in the U.S. medical device market.
The subject of this thesis was very extensive. Subsequently, the manufacturer cannot obtain all the regulatory information from this thesis. For instance, the manufacturer's actions and device must meet all the regulatory requirements of the FDA's own quality management system known as "QSR". There is a total of 15 subparts included in the QSR, and this thesis describes two of them (Production and Process Controls & Acceptance Activities). However, the 510(k) pathway is described extensively, and the manufacturer can learn its main points by reading this thesis. Consequently, the goal of this thesis was accomplished, as it provides a large amount of information and recommendations to a manufacturer wishing to market their medical device via the 510(k) pathway, but it also offers some basic knowledge of the U.S. regulatory requirements concerning medical devices.
This thesis focuses on requirements related to the 510(k) process and interpreted them from the manufacturer's point of view. In addition, it also addresses Food and Drug Administration's (FDA) Quality System Regulation (QSR) requirements that concern the device manufacturing stage (Production and Process Controls & Acceptance Activities). Consequently, this thesis aims to provide information on the 510(k) pathway and relevant QSR requirements to a manufacturer wishing to market its medical device in the U.S. medical device market.
The subject of this thesis was very extensive. Subsequently, the manufacturer cannot obtain all the regulatory information from this thesis. For instance, the manufacturer's actions and device must meet all the regulatory requirements of the FDA's own quality management system known as "QSR". There is a total of 15 subparts included in the QSR, and this thesis describes two of them (Production and Process Controls & Acceptance Activities). However, the 510(k) pathway is described extensively, and the manufacturer can learn its main points by reading this thesis. Consequently, the goal of this thesis was accomplished, as it provides a large amount of information and recommendations to a manufacturer wishing to market their medical device via the 510(k) pathway, but it also offers some basic knowledge of the U.S. regulatory requirements concerning medical devices.