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Ethics of Medical Product Development
Published in Howard Winet, Ethics for Bioengineering Scientists, 2021
An important concept for understanding the classification is “General controls”. If these are met by a device when a developer submits an FDA application to approve its marketing the device, the product is automatically classified as Class I. General controls are the basic provisions defined by the 1976 MDA. They include:Establishment Registration by manufacturers, distributors, repackages and re-labelers,Medical Device Listing with FDA of devices to be marketed,Manufacturing the devices in accordance with Good Manufacturing Practices,Labeling medical devices in accordance with FDA labeling regulations,Medical Device Reporting of adverse events as identified by the user, manufacturer and/or distributor of the medial device.
United States Medical Device Regulatory Framework
Published in Jack Wong, Raymond K. Y. Tong, Handbook of Medical Device Regulatory Affairs in Asia, 2018
General controls are regulatory requirements authorized by the FD&C Act, under sections 501, 502, 510, 516, 518, 519, and 520. The FD&C Act requires baseline controls necessary for marketing, proper labeling, and monitoring performance once a device is on the market. Unless exemption is specifically stated in the classification regulation, all devices must comply with the following general controls:Adulteration and MisbrandingEstablishment Registration and Medical Device ListingPremarket Notification (510k), unless exemptLabeling requirementsQuality System Regulation/Good Manufacturing Practices (GMP)Medical Device Reporting (MDR)
Perspectives on the Translational Aspects of Articular Cartilage Biology
Published in Kyriacos A. Athanasiou, Eric M. Darling, Grayson D. DuRaine, Jerry C. Hu, A. Hari Reddi, Articular Cartilage, 2017
Kyriacos A. Athanasiou, Eric M. Darling, Grayson D. DuRaine, Jerry C. Hu, A. Hari Reddi
Approval by the CDRH depends on the device’s class (Figure 6.12). Class I devices are low risk and pose minimal potential harm. The key regulatory compliance for a Class I device is that a company must demonstrate that it has implemented “general controls.” General controls include quality system regulation, as described by 21 CFR 820 (FDA 2011d), to ensure adherence to predefined design controls and cGMP; label requirements to prevent product mislabeling; and the use of Medical Device Reporting (MDR), as the mechanism to maintain records for the reporting of adverse events identified by the user, manufacturer, or distributer of the device. Handheld instruments, elastic bandages, exam gloves, and enema kits are examples of Class I devices. As part of the pathway to market, medical devices must use forms FDA-2891 and FDA-2892 for establishment, registration, and medical device listing.
Biosynthetic alternatives for corneal transplant surgery
Published in Expert Review of Ophthalmology, 2020
May Griffith, Bijay Kumar Poudel, Kamal Malhotra, Naoufal Akla, Miguel González-Andrades, David Courtman, Victor Hu, Emilio I. Alarcon
Apart from adherence to standards, xenogeneic source materials should be considered for possible zoonotic transmission. On the other hand, some synthetic polymers are sources for possible allergic reactions or transmission of pathogenic agents. It is therefore prudent to look into the literature for any previous reports of these issues as well as searchable and databases such as the US FDA’s ‘MAUDE – Manufacturer and User Facility Device Experience’ to see if there have been any problems reported. Adverse event reporting data files can be found under Medical Device Reporting (MDR) data for devices designed for similar purposes, to avoid the same issues. Conversely, published pre-market and market approvals of materials are useful for determining the safety of a raw material or a component used in an implant. However, careful evaluation of the source and purification processes employed with these materials are essential as these often define the materials’ clinical safety profile.
Close, but no cigar: Biosimilar products and firm regulatory stance
Published in International Journal of Healthcare Management, 2021
There are avenues for multiple medical product adverse event reporting, including the Vaccine Adverse Event Reporting System (VAERS), the FDA Adverse Event Reporting System (FAERS) and Medical Device Reporting (MDR) system. These databases are not always mandatory, nor do they capture the complete picture of product issues. Still, they are a reliable source of information, a means for the provider and clinical data collection, and can serve as an alert for overseers in population health. Because of the special interest and lack of full understanding in biosimilars, a biosimilar reporting system should be distinct, separate, and initiated through the FDA. As in other medical product reporting systems, this data collection should be formal in other countries as well.