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

Medicare : past experience can guide future competitive bidding for medical equipment and supplies : report to congressional committees.
Published: (2004)

FDA and industry actions on premarket approval applications (PMAs), effect on FDA review clock and goals.
Published: (2008)

Medical device regulation : too early to assess European system's value as model for FDA : report to the Chairman, Committee on Labor and Human Resources, U.S. Senate /
Published: (1996)

Premarket assessment of pediatric medical devices.
Published: (2004)

Annual reports for approved premarket approval applications (PMA).
Published: (2006)

Guidance for FDA reviewers : premarket notification submissions for transfer sets (excluding sterile connecting sets).
Published: (2001)

Biomedical technology assessment : the 3Q method /
by: Weinfurt, Phillip T. (Phillip Thomas), 1941-
Published: (2010)

FDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock and performance assessment.
Published: (2004)

Medical device design : innovation from concept to market /
by: Ogrodnik, Peter J.
Published: (2020)

Medical device design : innovation from concept to market /
by: Ogrodnik, Peter J.
Published: (2020)

Medicare : lack of price transparency may hamper hospitals' ability to be prudent purchasers of implantable medical devices : report to the Chairman, Committee on Finance, U.S. Senate.
Published: (2012)

Guidance for industry and FDA staff : interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements.
Published: (2008)

Food and Drug Administration : limited available data indicate that FDA has been meeting some goals for review of medical device applications : report to congressional committees.
Published: (2005)

Food and Drug Administration : limited available data indicate that FDA has been meeting some goals for review of medical device applications : report to congressional committees.
Published: (2005)

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)

New medical devices : invention, development, and use /
Published: (1988)

Evaluation of field clinical laboratory equipment for fleet marine service /
Published: (1994)

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

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

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

Medical device design : innovation from concept to market /
by: Ogrodnik, Peter J.
Published: (2020)

Information sheet guidance for IRBs, clinical investigators, and sponsors : significant risk and nonsignificant risk medical device studies.
Published: (2006)

Premarket approval application filing review.
Published: (2003)

Real-time premarket approval application (PMA) supplements.
Published: (2006)

Premarket approval application modular review.
Published: (2003)

Examining improvements to the regulation of medical technologies : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Fifteenth Congress, first session, May 2, 2017.
Published: (2018)

Classification names for medical devices and in vitro diagnostic products /
Published: (1991)

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

Annual report.

Annual report /

Bundling multiple devices or multiple indications in a single submission.
Published: (2007)

Medical device regulation : FDA-CDRH manufacturing, policies and regulation handbook /
by: Wreh, Elijah
Published: (2023)

Medical technology, health care, and the consumer /
Published: (1981)

Medical devices and the FDA : regulation, user fees and tort claims /
Published: (2013)

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