Regulatory Affairs

Office of the Vice President and Innovation

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Recently Posted FDA Guidance Documents

1/24/2020 – Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment: Guidance for Industry 1/22/2020 – Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff […]

Recently Posted FDA Guidance Documents

12/20/2019 – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff The Food and Drug Administration (FDA) has developed this document to describe relevant information that should be included in test report summaries, test protocols and complete test reports for non-clinical bench performance testing provided […]

SAVE THE DATE: 2020 Public Training Courses, Workshops, and Meetings

January 28-30, 2020: ASM Biothreats (Arlington, VA) – Hosted by the American Society for Microbiology, to offer professionals in biodefense, biosecurity, and biological threats the opportunity to exchange knowledge and ideas, and explore the latest developments and emerging technologies. (fee) January 28-29, 2020: HHS Tick-Borne Disease Working Group public meeting (Washington, DC and webcast) – The Working Group will 1) […]

Public Workshop – Artificial Intelligence in Radiological Imaging

The U.S. Food and Drug Administration (FDA) announced a public workshop entitled “Evolving Role of Artificial Intelligence in Radiological Imaging,” will be held February 25-26, 2020. This workshop is an opportunity for stakeholders to provide feedback to the FDA on the following topics: Emerging applications of Artificial Intelligence (AI) in radiological imaging, including devices intended […]

Oct. 29: FDA Webinar: Collaborative Communities

Date: October 29, 2019 Time: 03:00 PM – 04:30 PM EDT (To ensure you are connected, please dial in 15 minutes prior to the start of the webinar.) Registration is not necessary. Establishing collaborative communities is one of the Center for Devices and Radiological Health’s (CDRH’s) three strategic priorities for 2018-2020. CDRH envisions collaborative communities as […]

Posted FDA Guidance Documents

10/24/2019 – Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry This guidance provides information on the implementation of section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(o)(3)), which authorizes FDA to require certain postmarketing studies and clinical trials […]

New from CDRH

The Center for Devices and Radiological Health (CDRH) posted these new items on on October 24, 2019. To view listings for other dates, see CDRH New – News and Updates. Federal Register: Orthopedic Devices; Classification of Orthopedic Surgical Instrumentation Designed for Osteochondral Implants with Press-Fit Fixation Federal Register: Physical Medicine Therapeutic Devices; Classification of the Internal Therapeutic […]

Replies to Inquiries to FDA on Good Clinical Practice

GCP inquiries submitted by the public to the FDA’s Good Clinical Practice Program’s e-mail account are now available online. FDA on GCP Link: Visit this FDA page to search through years of answers to GCP related questions on: Adverse Events Inquiries Computer Questions Device Study Inquiries FDA Forms 1571 and 1572 Financial Disclosure Inquiries Foreign […]

Webinar on PHUSE/FDA Data Science Innovation Challenge

October 8, 2019 10:00 a.m. – 11:00 am EDT PHUSE invites you to a special webinar announcing the “PHUSE/FDA Data Science Innovation Challenge”. The challenge provides a framework and an opportunity for the greatest minds in the data sciences arena to come together and collaborate intensively on projects during a defined time frame to create […]

Six New Modules added to CDER Learn

CDRH Learn is the FDA’s Center for Devices and Radiological Health (CDRH) web page for multimedia industry education and provides free learning modules describing many aspects of medical device and radiation-emitting product regulations, covering both premarket and postmarket topics. New modules were added on September 30, 2019: Start Here/The Basics! – (New modules 9/30/19)MDUFA Small Business […]

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