Implementation of Recommendations from the 510(k) and Science Reports
The links below provide information on steps CDRH is taking to foster medical device innovation and assure the safety and effectiveness of medical technologies used in the United States.
The Summary and Overview of Comments and Next Steps below describes which recommendations from the August 2010 reports on the 510(k) program and CDRH's use of science in its decision-making we will implement.
The Summary is accompanied by a Plan of Action, which outlines 25 specific actions and accompanying timelines for completion or for reaching a milestone in 2011. These actions will make the 510(k) program a blueprint for smarter medical device oversight; one that drives innovation and brings important technologies to patients.
Overview of FDA Actions
Information on Improving Pre-Market Programs
Plan of Action for Implementation of 510(k) and Science Recommendations(PDF - 130KB) Questions About the Plan of Action? Submit Here
- Initial Results of 510(k) Audit - Analysis of Not Substantially Equivalent (NSE) Determinations (PDF - 268KB)
Medical Device Reporting (MDR) Rate in 510(k) Cleared Devices Using Multiple Predicates
- Analysis of Premarket Review Times Under the 510(k) Program (PDF - 420KB)
Innovation Pathway[ARCHIVED] Unique Device Identification - UDI
Guidance, Regulation, and Standard Operating Procedures
Guidance for Industry and Food and Drug Administration Staff - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications(PDF - 1.1MB) Federal Register Notice: Standard Operating Procedure for Notice to Industry Letters Center for Devices and Radiological Health Standard Operating Procedure (SOP) - Level 1, Immediately in Effect Guidance Documents on Premarket Data Issues(PDF - 484KB) CDRH Guidance Development SOP(PDF - 165KB) SOP: Decision Authority for Additional or Changed Data Needs for Premarket Submissions (Withdrawn) Guidance for Industry and FDA Staff - 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device FDA Decisions for Investigational Device Exemption Clinical Investigations - Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff(PDF - 631KB) De Novo Classification Process (Evaluation of Automatic Class III Designation) - Draft Guidance for Industry and Food and Drug Administration Staff (PDF Only) Design Considerations for Pivotal Clinical Investigations for Medical Devices - Guidance for Industry, Clinical Investigators, Institutional Review Boards and Food and Drug Administration Staff SOP: Management of Review Staff Changes During the Review of a Premarket Submission Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics: Draft Guidance for Industry and Food and Drug Administration Staff Center for Devices and Radiological Health Appeals Processes - Guidance for Industry and Food and Drug Administration Staff Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff - Guidance for Industry and Food and Drug Administration Staff(PDF - 324KB) Proposed Rule: Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices 510(k) Third Party Review Program - Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations(PDF - 1.1MB)
CDRH Center Science Council (CSC)
The CSC provides oversight of the Center’s science programmatic functions and helps share knowledge throughout the Center, consistent with CDRH’s other ongoing efforts to improve internal communication, consistency, transparency, and quality in scientific decision making, and predictability of regulatory pathways and requirements.
Network of Experts
The Food and Drug Administration (FDA) is announcing the availability of the standard operating procedure (SOP) for “Network of Experts.” The SOP describes the Center for Devices and Radiological Health’s (CDRH) process to provide CDRH staff with rapid access to scientific, engineering, and medical expertise when it is needed to supplement existing knowledge and expertise within the Center.
Network of Experts- Expert Utilization Standard Operating Procedure (DRAFT) Network of Experts - Expert Enrollment Standard Operating Procedure (FINAL) Federal Register: Center for Devices and Radiological Health; Standard Operating Procedures for Network of Experts; Request for Comments FDA Outlines Plans for an Outside Network of Scientific Experts[ARCHIVED]
510(k) and Science Report Recommendations: Summary and Overview of Comments and Next Steps(PDF - 188KB) Letter From the Center Director(PDF - 43KB) FDA to improve most common review path for medical devices[ARCHIVED] CDRH Preliminary Internal Evaluations -- Foreword: A Message from the Center Director(PDF - 243KB) CDRH Preliminary Internal Evaluations -- Volume I: 510(k) Working Group Preliminary Report and Recommendations(PDF - 1.8MB) CDRH Preliminary Internal Evaluations -- Volume II: Task Force Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations(PDF - 672KB) FDA Issues Assessments of the 510(k) Program and Use of Science in Decision-Making[ARCHIVED]
- Federal Register: CDRH 510(k) Working Group Preliminary Report and Recommendations, and Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations
CDRH Preliminary Internal Evaluations -- Basic Questions and Answers on Preliminary Reports