Contact and support
Need help, have a question, or want to contact the ResearchHub team?
© 2026 ResearchHub. Built for responsible scholarly connection.
Privacy-aware community infrastructureResearch graph
References from Drugs, Devices, and the FDA: Part 2. Local targets link to admitted publications; unresolved targets remain external evidence.
Unresolved reference
External reference
Unresolved reference
External reference
The FDA approval process for medical devices: an inherently flawed system or a valuable pathway for innovation?
10.1136/neurintsurg-2012-010400 · 2013 · External reference
Unresolved reference
External reference
Unresolved reference
External reference
Unresolved reference
External reference
Unresolved reference
External reference
Medical device development: from prototype to regulatory approval
10.1161/01.cir.0000134695.65733.64 · 2004 · External reference
Unresolved reference
External reference
Unresolved reference
External reference
Unresolved reference
External reference
Demystifying the U.S. Food and Drug Administration: understanding regulatory pathways
10.1097/prs.0000000000000477 · 2014 · External reference
Unresolved reference
External reference
Unresolved reference
External reference
Unresolved reference
External reference
Unresolved reference
External reference
Unresolved reference
External reference
Unresolved reference
External reference
Unresolved reference
External reference
Understanding levels of evidence for scientific communication
10.1177/1938640010375184 · 2010 · External reference
The FDA approval process for medical devices; an inherently flawed system, or valuable pathway for innovation?
10.1136/neurintsurg-2012-010400 · 2013 · External reference
Unresolved reference
External reference
Unresolved reference
External reference
AIDS and the politics of drug lag
1989 · External reference
The 21st Century Cures Act—will it take us back in time?
10.1056/nejmp1506964 · 2015 · External reference
Unresolved reference
External reference
Unresolved reference
External reference
Unresolved reference
External reference
Unresolved reference
2011 · External reference
Misuse of the FDA's humanitarian device exemption in deep brain stimulation for obsessive compulsive disorder
10.1377/hlthaff.2010.0157 · 2011 · External reference
Medical devices–balancing regulation and innovation
10.1056/nejmp1109094 · 2011 · External reference
Acute stroke therapy at the crossroads
10.1001/jama.2011.1622 · 2011 · External reference
Unresolved reference
External reference
Unresolved reference
External reference
Unresolved reference
External reference
Unresolved reference
External reference
Unresolved reference
External reference
Unresolved reference
External reference
Unresolved reference
External reference
Unresolved reference
External reference
The pathway from idea to regulatory approval: examples for drug development
2009 · External reference
Unresolved reference
External reference
Unresolved reference
External reference
Safe Medical Devices Act: management guidance for hospital compliance with the new FDA requirements
1993 · External reference
Unresolved reference
External reference
Unresolved reference
External reference
Characteristics of clinical studies conducted over the total product life cycle of high-risk therapeutic medical devices receiving FDA premarket approval in 2010 and 2011
10.1001/jama.2015.8761 · 2015 · External reference
Unresolved reference
External reference
