Annual reports for approved premarket approval applications (PMA).

Premarket approval application filing review.
Published: (2003)

Premarket approval application modular review.
Published: (2003)

User fees and refunds for premarket approval applications.
Published: (2003)

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

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

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

Approval of medical devices.
Published: (2014)

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

User fees and refunds for premarket notification submissions (510(k)s).
Published: (2004)

Annual report.

Annual report /

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

Annual report /
Published: (2003)

Annual report /

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)

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

FDA medical device approval : is there a better way? : hearing before the Subcommittee on Health Care, District of Columbia, Census, and the National Archives of the Committee on Oversight and Government Reform, House of Representatives, One Hundred Twelfth Congress, first session, June 2, 2011.
Published: (2011)

FDA medical device approval : is there a better way? : hearing before the Subcommittee on Health Care, District of Columbia, Census, and the National Archives of the Committee on Oversight and Government Reform, House of Representatives, One Hundred Twelfth Congress, first session, June 2, 2011.
Published: (2011)

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)

Annual report of the Office of Science and Technology.
Published: (1985)

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)

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)

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)

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

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

The validity of the ViaMed blood glucose monitoring system /
by: Barrett, Sarah Ann
Published: (2001)

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

Medical device reporting : improvements needed in FDA's system for monitoring problems with approved devices : report to congressional committees /
Published: (1997)

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

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

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)

Food and Drug Administration : data to measure the timeliness of reviews of medical device applications are limited : report to congressional committees.
Published: (2004)

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