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

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

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

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)

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

Premarket approval (PMA) manual /
Published: (1986)

Premarket approval (PMA) manual /
by: Kyper, Charles
Published: (1993)

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

Guidance for FDA reviewers : premarket notification submissions for blood and plasma warmers.
Published: (2001)

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

Guidance for industry, FDA staff, and FDA-accredited third parties.
Published: (2009)

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

Modifications to devices subject to premarket approval (PMA) : the PMA supplement decision-making process.
Published: (2008)

Draft guidance for industry and FDA : consumer-directed broadcast advertising of restricted devices.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

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)

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

FDA & you.
Published: (2009)

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

FDA CDRH annual report.

Draft guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and FDA staff : humanitarian device exemption regulation, questions and answers.
Published: (2008)

FDA and the medical device industry : hearings before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Second Congress, second session, March 25 and June 3, 1992.
Published: (1992)

Guidance for industry and FDA staff : early development considerations for innovative combination products.
Published: (2006)

FDA medical product approvals : hearing before the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and Oversight, House of Representatives, One Hundred Fourth Congress, first session, August 8, 1995.
Published: (1997)

FDA oversight : medical devices : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, Ninety-seventh Congress, second session, July 16, 1982.
Published: (1982)

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)

FDA's Center for Devices and Radiological Health : a profile.
Published: (1995)

Guidance for industry and FDA staff : devices used to process human cells, tissues, and cellular and tissue-based products (HCT/Ps).
Published: (2007)

FDA user fees : advancing public health : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Twelfth Congress, first session ... July 28, 2011.
Published: (2014)

The FDA medical device user fee program /
by: Johnson, Judith A. (Judith Ann), 1957-
Published: (2020)

Mastering and managing the FDA maze : medical device overview : a training and management desk reference for manufacturers regulated by the Food and Drug Administration /
by: Harnack, Gordon, 1939-
Published: (1999)

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

FDA Reauthorization Act of 2017 : report (to accompany H.R. 2430).
Published: (2017)

FDA and the medical device industry : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred First Congress, second session, February 26, 1990.
Published: (1990)

FDA drug approval : application review times largely reflect FDA goals : report to congressional requesters.
Published: (2020)

HHS announcement on FDA premarket review of laboratory-developed tests (LDTs) /
by: Sarata, Amanda K.
Published: (2020)