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United States Medical Device Regulatory Framework
Published in Jack Wong, Raymond K. Y. Tong, Handbook of Medical Device Regulatory Affairs in Asia, 2018
Device manufacturers must comply with the FDA Quality System Regulation (21 CFR Part 820). The regulation includes requirements related to the methods used in the facilities and controls used for designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices in order to conform to current GMPs. The FDA inspects manufacturing facilities to assure compliance with the QS requirements. Certain types of devices are exempt from GMP. However, exemption from GMP requirements does not exempt manufacturers from keeping complaint files or from general requirements concerning records. IDE clinical studies are exempt from GMP, except for the Design Controls that provide the requirement for procedures to control the design of the device in order to ensure that the specified design requirements are met.
Conformity Assessment
Published in Robert D. Hunter, for Engineers, 2017
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) in the Department of Health and Human Services (DHHS) is responsible for conformity assessment of medical devices, a subject of interest to biomedical engineers. The authority for the program is the Medical Device Amendments (P.L. 94–295) to the Food, Drug and Cosmetic Act (Title 21 U.S.C.). The purpose of this program is to assure that medical devices are both safe and effective for their intended uses. Unless exempted by regulation, all medical device manufacturers are required to give the FDA 90-days notice before they intend to market a device by submitting a premarket notification. The FDA, during the 90-day period, determines if the device is equivalent to a preamendment device. A medical device may not be marketed until the manufacturer receives a notice from the agency that its device does not require premarket approval (PMA).
Mobile Medical Devices
Published in Ali Youssef, Douglas McDonald II, Jon Linton, Bob Zemke, Aaron Earle, Wi-Fi Enabled Healthcare, 2014
Ali Youssef, Douglas McDonald II, Jon Linton, Bob Zemke, Aaron Earle
In June of 2013 the FDA released a draft guidance pertaining to the cybersecurity of medical devices. The target audiences were primarily medical device manufacturers, and the document entitled “Content of premarket submissions for management of cybersecurity in medical devices” calls attention to intentional threats to medical devices. These range from Malware and viruses infecting medical devices to organized penetration and Denial of Service attacks. The ruling urges medical device manufacturers to develop a set of security controls to assure medical devices maintain information confidentiality, integrity, and availability. In part, this means implementing two factor authentication mechanisms including passwords, biometric identifiers, or smartcards in order to restrict the number of individuals capable of interacting with the product.
Multi-Criteria Decision Making for Medical Device Development
Published in Engineering Management Journal, 2023
Houssem Barkaoui, Helmi Ben Rejeb, Abdelwahed Barkaoui, João Manuel R.S. Tavares
One of the most significant barriers that medical device manufacturers face is compliance with legislation. No medical device is allowed to be introduced into the market unless it receives clearance for commercialization. In the United States, the Center for Devices and Radiological Health, which is a department of the Food and Drug Administration (FDA), is responsible for medical device regulations (Maisel, 2004; Zuckerman et al, 2011). Each type of device is assigned by the FDA to one of three regulatory classes on the basis of its risk, safety, and effectiveness (Kramer et al, 2012). In Europe, the first European regulatory system was launched in 1993. Before 1993, legislation varied from one EU country member to another, and each member had its own registration (Fleur, 1997; Niederländer et al, 2013). In addition to the regional regulations, there are also other consensus statements, interpretative documents, and standards, which are created by organizations like the International Organization for Standardization and which manufacturers, suppliers and users must comply with.
Blockchain technology applications to postmarket surveillance of medical devices
Published in Expert Review of Medical Devices, 2020
Josep Pane, Katia M.C. Verhamme, Lacey Shrum, Irene Rebollo, Miriam C.J.M. Sturkenboom
Yet another solution would be to ensure full data privacy to participants during the PMS data transaction, while still being able to validate the authenticity of the transaction. However, some of the participants in our private blockchain could be medical device manufacturers. The conventional blockchain application would allow participants to obtain sensitive private data about their competitors. To eliminate any risk of competitors acquiring sensitive information about each other, our PMS private blockchain should build a zero-knowledge proof algorithm mechanism ensuring that competitors cannot see the transaction data of their competitors, while allowing transactions to be validated [34].
Progress in large field-of-view interventional planar scintigraphy and SPECT imaging
Published in Expert Review of Medical Devices, 2022
Martijn M.A. Dietze, Hugo W.A.M de Jong
It seems that the supporting gantries of the mobile scanners could be relatively easily adapted to perform interventional SPECT by making the gantry automatically rotate the camera around the patient. An anatomical reference may be retrieved from the CBCT scanner that is available in the intervention room. With a method to calibrate the reference frames of both systems (e.g. by positioning radioactive sources that can be detected on both SPECT and CBCT), sufficiently accurate registration between both frames should be achievable. We recommend medical device manufacturers to further explore this option.