Federal regulation of medical devices began in 1976 with the signing of the Medical Device Amendments to the Food, Drug and Cosmetic Act. For the purpose of regulating medical devices, the Food and Drug Administration is divided into various divisions and branches, including the Office of Device Evaluation. The evolution of the Food and Drug Administration's regulations of laparoscopic devices is described. Also described is the technology of laparoscopic surgical devices and how they are regulated by the Office of Device Evaluation. Trends towards the future of laparoscopic devices, and their regulation, are reviewed.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1177/107155170301000304 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
ISCT MSC committee statement on the US FDA approval of allogenic bone-marrow mesenchymal stromal cells.
Cytotherapy
January 2025
Osteoarthritis Research Program, Division of Orthopedic Surgery, Schroeder Arthritis Institute, University Health Network, Toronto, Ontario, Canada; Krembil Research Institute, University Health Network, Toronto, Ontario, Canada; Institute of Biomedical Engineering, University of Toronto, Toronto, Ontario, Canada; Department of Medicine, Division of Hematology, University of Toronto, Toronto, Ontario, Canada. Electronic address:
The December 2024 US Food and Drug Administration (FDA) approval of Mesoblast's Ryoncil (remestemcel-L-rknd)-allogeneic bone marrow mesenchymal stromal cell (MSC(M)) therapy-in pediatric acute steroid-refractory graft-versus-host-disease finally ended a long-lasting drought on approved MSC clinical products in the United States. While other jurisdictions-including Europe, Japan, India, and South Korea-have marketed autologous or allogeneic MSC products, the United States has lagged in its approval. The sponsor's significant efforts and investments, working closely with the FDA addressing concerns regarding clinical efficacy and consistent MSC potency through an iterative process that spanned several years, was rewarded with this landmark approval.
View Article and Find Full Text PDFGenetic analysis reveals the genetic diversity and zoonotic potential of Streptococcus dysgalactiae isolates from sheep.
Sci Rep
January 2025
Department of Preclinical Sciences, Institute of Veterinary Medicine, Warsaw University of Life Sciences, Ciszewskiego 8 St, 02-786, Warsaw, Poland.
Streptococcus dysgalactiae (S. dysgalactiae ) is a common pathogen of humans and various animals. However, the phylogenetic position of animal S.
View Article and Find Full Text PDFPredictors, patterns, and correlates of moderate-severe psychological distress among New York City College Students during Waves 2-4 of COVID-19.
Sci Rep
January 2025
Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, 622 West 168th Street, Ste. 876, New York, NY, 10032, USA.
The COVID-19 pandemic may have exacerbated mental health conditions by introducing and/or modifying stressors, particularly in university populations. We examined longitudinal patterns, time-varying predictors, and contemporaneous correlates of moderate-severe psychological distress (MS-PD) among college students. During 2020-2021, participants completed self-administered questionnaires quarterly (T1 = 562, T2 = 334, T3 = 221, and T4 = 169).
View Article and Find Full Text PDFCarboxylated cellulose nanocrystals mediated flower-like zinc oxide for antimicrobial without activation of light.
J Colloid Interface Sci
April 2025
State Key Laboratory of Pulp and Paper Engineering, South China University of Technology, Guangzhou 510640, China. Electronic address:
Conventional light-driven antimicrobial strategies of zinc oxide (ZnO) are limited by inadequate illumination in dark environments. In this study, carboxylated cellulose nanocrystals (MCNC) mediated flower-like ZnO (C@Z) with self-promoted reactive oxygen species release under dark is fabricated. The adsorption of Zn ions on MCNC prompts the growth of ZnO along the (002) crystal plane, forming a flower-like hybrid with superior dispersibility and oxygen vacancies compared to MCNC-free ZnO, which exposes the (100) plane.
View Article and Find Full Text PDFThe risk of donor-acquired allergy in solid organ transplant recipients: a systematic review.
Ann Allergy Asthma Immunol
January 2025
Center for Drug Safety and Immunology, Vanderbilt University Medical Centre, Nashville, Tennessee, USA; Institute for Immunology and Infectious Diseases, Murdoch University, Murdoch, Western Australia, Australia.
Background: Donor acquired allergy (DAA) occurs when donors transfer their allergies to recipients through solid organ transplant (SOT). However, the risk of DAA in recipients of organs from allergic donors has not been systematically characterized.
Objective: We sought to synthesize the available evidence on the risk of DAA in SOT recipients.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!