Division of Clinical Research

Office of the Vice President and Innovation

Category results for: FDA Regulatory

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 […]

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 FDA.gov 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 gcp.questions@fda.hhs.gov e-mail account are now available online. FDA on GCP Link: https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/replies-inquiries-fda-good-clinical-practice 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 […]

Real Life Film Series: The Bleeding Edge

October 15, 2019 from 12:10 PM to 1:00 PM Tompkins McCaw Library, Lecture Room 2-010 (509 N. 12th St., Richmond, Va. 23298) Students, faculty, staff and health professionals are invited to the screening of the engaging documentary, The Bleeding Edge. Look at the unforeseen consequences of advanced technological devices used in the medical field. Then join […]

Recently Posted FDA Guidance Documents

9/27/2019 – Clinical Decision Support Software [DRAFT] The Food and Drug Administration (FDA) has long regulated software that meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including software that is intended to provide decision support for the diagnosis, treatment, prevention, cure, or mitigation of diseases […]

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