Information sheet guidance for IRBs, clinical investigators, and sponsors : significant risk and nonsignificant risk medical device studies.

Medical devices : application of risk management to medical devices = Dispositifs médicaux : application de la gestion des risques aux dispositifs médicaux.
Published: (2019)

Medical device GMP guidance for FDA investigators /
Published: (1984)

Guidance for clinical investigators, sponsors, and IRBs : adverse event reporting to IRBs : improving human subject protection.
Published: (2009)

Medical devices : shortcomings in FDA's premarket review, postmarket surveillance, and inspections of device manufacturing establishments : testimony before the Subcommittee on Health, Committee on Energy and Commerce, House of Representatives /
by: Crosse, Marcia
Published: (2009)

Medical devices : Application of risk management to medical devices = Dispositifs médicaux : Application de la gestion des risques aux dispositifs médicaux /
Published: (2019)

Guidance for industry : presenting risk information in prescription drug and medical device promotion.
Published: (2009)

Clinical investigations of medical devices in dentistry : specification, interpretation, and practical guidance /
by: Groten, Martin
Published: (2004)

New technologies in health care : challenge, change and innovation /
Published: (2006)

Reliable design of medical devices /
by: Fries, Richard C.
Published: (2006)

Guidance for industry and FDA staff : expedited review of premarket submissions for devices.
Published: (2008)

Medical device regulation : the FDA's neglected child : an oversight report on FDA implementation of the Medical Device Amendments of 1976 : report of the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, U.S. House of Representatives.
Published: (1983)

Approval of medical devices.
Published: (2014)

Guidance for industry : patient-reported outcome measures, use in medical product development to support labeling claims.
Published: (2006)

Medical device development : regulation and law /
by: Kahan, Jonathan S.
Published: (2009)

Managing the risks from medical product use : creating a risk management framework : report to the FDA Commissioner from the Task Force on Risk Management.
Published: (1999)

Safety Risk Management for Medical Devices /
by: Elahi, Bijan
Published: (2018)

Safety Risk Management for Medical Devices /
by: Elahi, Bijan
Published: (2018)

Design controls for the medical device industry /
by: Teixeira, Marie B., 1965-
Published: (2003)

Medical devices and equipment : competitive conditions affecting U.S. trade in Japan and other principal foreign markets.
Published: (2007)

Medical device epidemiology and surveillance /
Published: (2007)

Medical device establishment registration : information and instructions.
Published: (1987)

Guidance for industry : cell selection devices for point of care production of minimally manipulated autologous peripheral blood stem cells (PBSCs).
Published: (2007)

Trends in development of medical devices /
by: Shanmugam, Prakash Srinivasan Timiri
Published: (2020)

Practical Design Control Implementation for Medical Devices.
by: Justiniano, Jose
Published: (2003)

Draft guidance for industry and FDA : consumer-directed broadcast advertising of restricted devices.
Published: (2004)

FDA's clearance of medical devices through the 510(k) process.
Published: (2013)

Use of blunt-tip suture needles to decrease percutaneous injuries to surgical personnel.
Published: (2007)

Safety of electromedical devices : law, risk and opportunities /
by: Leitgeb, N.
Published: (2010)

Reliable design of medical devices /
by: Fries, Richard C.
Published: (1997)

Guidance for industry : "help-seeking" and other disease awareness communications by or on behalf of drug and device firms.
Published: (2004)

Guidelines for failure mode and effects analysis for medical devices /
Published: (2003)

Wearable and implantable medical devices : applications and challenges /
Published: (2020)

Medical device regulation in the United States and the European community /
by: Reyes-Akinbileje, Bernice
Published: (1992)

Federal policies and the medical devices industry.
Published: (1984)

Federal policies and the medical devices industry.
Published: (1984)

The future of medical device regulation : innovation and protection /
Published: (2022)