Jeffrey Shuren, M.D., J.D. Director Center for Devices and Radiological Health Food and Drug AdministrationNew Hampshire Avenue Silver Spring, MD

Source URL: www.nationalfccoalition.org

Digital Health Innovation Action Plan  Introduction FDA’s Center for Devices and Radiological Health (CDRH) puts patients at the forefront of our vision—we are driven by timely patient access to high-quality, s

Source URL: www.fda.gov

Post-doctoral fellow position #2 – Research Focus Nanotechnology/nanotoxicology - Safety of engineered nanomaterials The Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryl

Source URL: www.medicalgeology.org

Sunlamps: Regulatory Issues W. Howard Cyr, Ph.D. Office of Science and Technology, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD USA For distribution at the following meetings:

Source URL: www.fda.gov

Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases - Draft Guidance for Stakeholders and Food and Drug Administration

Source URL: www.fda.gov

• Food and Drug Administration
• Health
• Food law
• Pharmaceuticals policy
• Personal life
• Pharmaceutical industry
• Healthcare quality
• Federal Food
• Drug
• and Cosmetic Act
• Medical device
• Validation
• Center for Devices and Radiological Health
• RNA-Seq

FDA CENTER FOR DEVICES & RADIOLOGICAL HEALTH (CDRH), NATIONAL HEALTH INFORMATION SHARING ANALYSIS CENTER (NH-ISAC), THE DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS), AND

Source URL: www.fda.gov

• Computer security
• Government
• Security
• Cyberwarfare
• United States Department of Homeland Security
• National security
• Cybercrime
• NH-ISAC
• Cyber-security regulation
• United States Computer Emergency Readiness Team
• National Cybersecurity Center of Excellence
• Food and Drug Administration

IMDRF Presentation: Good Regulatory Review Practices Working Group Update

Source URL: www.imdrf.org

• Medicine
• Medical technology
• Medical equipment
• Health
• Food and Drug Administration
• Medical device
• Center for Devices and Radiological Health

Deciding When to Submit a 510(k) for a Software Change to an Existing Device - Draft Guidance for Industry and Food and Drug Administration Staff

Source URL: www.fda.gov

• Health
• Pharmaceutical industry
• Business
• Food and Drug Administration
• Medicine
• Pharmaceuticals policy
• Quality management
• Medical technology
• Medical device
• Federal Food
• Drug
• and Cosmetic Act
• Risk management
• Center for Devices and Radiological Health

Post doctoral fellow position Nanotechnology/nanotoxicology - Safety of engineered nanomaterials The Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, invites applicati

Source URL: www.medicalgeology.org

• Emerging technologies
• Nanomaterials
• Nanoparticles
• Nanotoxicology
• Nanotechnology
• Technology
• Technological change
• Time
• Impact of nanotechnology
• Draft:Nanoparticles

Combination Product Review, Intercenter Consult Process Study

Source URL: www.fda.gov

• Food and Drug Administration
• Health
• Center for Devices and Radiological Health