Draft guidance for industry and FDA : consumer-directed broadcast advertising of restricted devices.

Guidance for industry : consumer-directed broadcast advertisements, questions and answers.
Published: (1999)

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

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)

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

Draft guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and FDA staff : humanitarian device exemption regulation, questions and answers.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

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

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

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

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

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

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

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

Guidance for industry : FDA export certificates.
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)

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

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

Guidance for industry : class II special controls guidance document : cord blood processing system and storage container.
Published: (2007)

Guidance for industry : use of sterile connecting devices in blood bank practices.
Published: (2000)

Guidance for industry : drugs, biologics and medical devices derived from bioengineered plants for use in humans and animals.
Published: (2002)

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

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

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

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

FDA CDRH annual report.

Better health care with quality medical devices : FDA on the cutting edge of device technology.
Published: (2002)

Marketing or medicine : are direct-to-consumer device ads playing doctor? : hearing before the Special Committee on Aging, United States Senate, One Hundred Tenth Congress, second session, Washington, DC, September 17, 2008.
Published: (2009)

Marketing or medicine : are direct-to-consumer device ads playing doctor? : hearing before the Special Committee on Aging, United States Senate, One Hundred Tenth Congress, second session, Washington, DC, September 17, 2008.
Published: (2009)

Information sheet guidance for IRBs, clinical investigators, and sponsors : frequently asked questions about medical devices.
Published: (2006)

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

Medical devices and the public's health : the FDA 510(k) clearance process at 35 years /
Published: (2011)

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

Guidance for industry : the use of mechanical calibration of dissolution apparatus 1 and 2, current good manufacturing practice (CGMP).
Published: (2007)

Guidance for industry and staff : resolution of disputes concerning payment or refund of medical device user fees under MDUFMA.
Published: (2004)