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Bayesian Statistical Methodology in the Medical Device Industry
Published in Emmanuel Lesaffre, Gianluca Baio, Bruno Boulanger, Bayesian Methods in Pharmaceutical Research, 2020
A medical device is broadly defined as a device designed through mechanical and electrical engineering intended to affect the structure or any function of the human body and which does not achieve its primary purpose through use of a pharmacological substance. The medical devices industry is a highly-regulated industry. In the United States, like pharmaceuticals, medical devices are regulated by the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH).
Cosmetic Surgery Of The Breast
Published in M. Sandra Wood, Internet Guide to Cosmetic Surgery for Women, 2013
The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health, regulates breast implants. The site (see Figure 6.5) has a comprehensive “Breast Implant Consumer Handbook,” an extensive (eighty-two-page) document in PDF format that covers everything from the surgery to risks, serious problems, and FDA regulatory activities related to breast implants (status/availability of implants); click on the link just under the “Handbook” (Breast Implants—An Information Update—2000), or go directly to <http://www.fda.gov/cdrh/breastimplants/indexbib.html>. Other information includes a brochure on risks, photographs of complications, and information on breast implant studies. You can sign up for the “Breast Implant Listserv” to receive a monthly update from the FDA on implants. This site is a “must visit” for any woman considering breast implants.
Overview of Benefit–Risk Evaluation Methods: A Spectrum from Qualitative to Quantitative
Published in Qi Jiang, Weili He, Benefit-Risk Assessment Methods in Medical Product Development, 2017
George Quartey, Chunlei Ke, Christy Chuang-Stein, Weili He, Qi Jiang, Kao-Tai Tsai, Guochen Song, John Scott
There are also vast efforts from health authorities and academia to standardize, streamline, and improve the BRA process. For example, the Prescription Drug User Fee Act (PDUFA) V commits the Food and Drug Administration (FDA) to a series of meetings and workshops during 2013–2018 to develop a BRA framework. The FDA released a 2013 draft benefit–risk (B–R) implementation plan entitled “Structured Approach to Benefit–Risk Assessment in Drug Regulatory Decision-Making” (FDA 2013). The European Medicines Agency (EMA) Benefit–Risk Methodology Project was aimed at the development and testing of tools and processes for balancing multiple benefits and risks, which could be used as an aid to informed, science-based regulatory decisions about medicinal products (EMA Methodology Project 2013; EMA Reflection Paper 2008). The Institute of Medicine recommended that the FDA create a publicly available BRA management plan with periodic updates. In addition, several other proposed structured BRA initiatives developed by the PhRMA BRAT (Pharmaceutical Research and Manufacturers of America Benefit–Risk Action Team) (Coplan et al. 2011), the Universal Methodology for Benefit–Risk Assessment (UMBRA) framework by the Centre for Innovation in Regulatory Science organization (Walker et al. 2015), the PrOACT-URL framework recommended by the EMA (Phillips et al. 2013), FDA Center for Devices and Radiological Health (CDRH) Decision Analysis Initiative and CDRH/Center for Biologics Evaluation and Research Benefit–Risk Guidance, and the Periodic Benefit–Risk Evaluation Report based on the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidance (ICH E2C(R2) 2012) have placed a descriptive approach as a critical part of BRA.
The current status of breakthrough devices designation in the United States and innovative medical devices designation in Korea for digital health software
Published in Expert Review of Medical Devices, 2022
Jae Hyun Woo, Eun Cheol Kim, Sung Min Kim
The US Breakthrough Devices Designation can be made public or private at the request of the company. Accordingly, it is not possible to completely track the designation status. Based on the data released by the FDA Center for Devices and Radiological Health(CDRH) in February 2021, more than 400 were designated as innovative medical devices [41]. In addition, based on the designation status published in Medtech Insight [42], 309 devices were designated following an upgrade by 31 December 2021, including a total of 283 (91.6%) cases of medical devices/in vitro diagnosis and 26 (8.4%) cases of software. Based on the analysis of recent three-year data, 80 cases in 2019, 90 cases in 2020, and 123 in 2021 were designated, with an increasing trend. A total of 23 (7.4%) approved or cleared items were designated by 31 December 2021. The result of urbanizing the information is as shown in Figure 2.
Blood-based traumatic brain injury biomarkers – Clinical utilities and regulatory pathways in the United States, Europe and Canada
Published in Expert Review of Molecular Diagnostics, 2021
Kevin K. Wang, Jennifer C. Munoz Pareja, Stefania Mondello, Ramon Diaz-Arrastia, Cheryl Wellington, Kimbra Kenney, Ava M. Puccio, Jamie Hutchison, Nicole McKinnon, David O. Okonkwo, Zhihui Yang, Firas Kobeissy, J. Adrian Tyndall, András Büki, Endre Czeiter, Maria C. Pareja Zabala, Nithya Gandham, Rebecca Berman
If a ‘Predicate Device’ already exists, then a ‘510(k)’ premarket notification pathway can be selected by the sponsoring entity seeking regulatory approval. On the other hand, for a new intended use of an existing analyte, a more elaborated ‘de novo’ or ‘Premarket Approval (PMA)’ application must be submitted. For such IVD regulatory path, the sponsoring entity must clearly define the intended use and intended setting for the TBI IVD test and the technology. A Pre-Investigational Device Exemption meeting with representatives from FDA-Center for Devices and Radiological Health (CDRH) and FDA-Office of In Vitro Diagnostic Device Evaluation and Safety usually precedes official IDE filing (with submission of supportive data package). A favorable outcome will be that such a TBI in vitro diagnostic device is approved by FDA to enter the market for the stated intended use (Figure 3). Under this path, a demonstration of clinical utility is not necessary for FDA clearance or approval. Nonetheless, evidence of clinical utility is a fundamental aspect that must be gathered and considered by decision-makers before determining the reimbursement of a test cost.
Long-term safety and efficacy of breast biopsy markers in clinical practice
Published in Expert Review of Medical Devices, 2021
Sharon Smith, Clayton R. Taylor, Estella Kanevsky, Stephen P. Povoski, Jeffrey R. Hawley
The safety and reliability of medical devices are regulated through organizations such as the US Food and Drug Administration (FDA) Center for Devices and Radiological Health and European Medicines Agency (EMA) with recommendations of best practice by the Global Harmonization Task Force (GHTF) and the International Organization for Standardization [19]. The FDA mandates manufacturers, importers, and device user facilities, such as hospitals, surgery centers, and nursing homes, to report any incidence of adverse effects, device failures, and deficiencies. Health-care providers, patients, and consumers are also encouraged to make voluntary reports. Reports are then entered into the Manufacturer and User Facility Device Experience (MAUDE) or MedSun Databases which are publicly accessible [20]. Similarly, the EU mandates manufacturers to report device-related serious AEs, device failures/malfunction, or labeling inaccuracies that might lead to or might have led to death or serious injury, to their competent authority (CA) in the nation of occurrence. These data are submitted by the CAs to the European Databank on Medical Devices (EUDAMED). This database is not currently accessible to the public [21].