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Accomplishments: CDRH Plan of Action for 510(k) and Science
CDRH Plan of Action for 510(k) and Science - Implementation
| Recommendation | Purpose | Milestone/Deliverable | Completion Date |
|---|---|---|---|
| Implement an "Assurance Case" Pilot Program | To explore the use of an “assurance case” framework for 510(k) submissions. | Start pilot program Pilot program underway See infusion pump website. |  March 31, 2011 |
| Establish a Center Science Council | To: 1) oversee the development of a business process and SOP for determining and implementing an appropriate response to new scientific information; 2) promote the development of improved metrics to continuously assess the quality, consistency and effectiveness of the pre-market programs; 3) periodically audit pre-market review decisions to assess adequacy, accuracy and consistency; and 4) establish an internal team of clinical trial experts to provide support and advice on clinical trial design for Center staff and prospective IDE applicants. | Post Council Charter to FDA Website | March 31, 2011 |
| Provide Additional Information About Regulated Products | To make device photographs available in a public database without disclosing proprietary information. | Public Meeting * | April 7, 2011 |
| Improve Medical Device Labeling | To develop an on-line labeling repository. | Public Meeting * | April 7, 2011 |
| Improve Collection and Analysis of Postmarket Information | To develop better data sources, methods and tools for collecting and analyzing meaningful postmarket information, and to enhance the Center’s capabilities to support evidence synthesis and quantitative decision making. | Determine system requirements and select the platform for a new adverse event database System requirements determined | June 30, 2011 |
| Improve the IDE Process | To better characterize the root causes of existing challenges and trends in IDE decision making. Assess, characterize and mitigate challenges in reviewing IDE’s. | Complete program assessment Assessment completed | June 30, 2011 |
| Establish "Notice to Industry Letters" as a Standard Practice | To clarify and more quickly inform stakeholders when CDRH has changed its regulatory expectations on the basis of new scientific information. | Post SOP to FDA Website | June 15, 2011 |
| Establish a Center Science Council | See Above. | Post initial results of 510(k) audit to FDA Website | June 15, 2011 |
| Assess Center Staffing Needs | To formalize the Center’s internal process for identifying staffing needs, and to enhance recruitment, retention, training, and professional development of review staff. To create a mechanism to assemble an experienced ad hoc team to temporarily assist with unexpected surges in workload. | Develop process for identifying, recruiting, retaining, and training needed staff Internal SOP completed | July 15, 2011 |
| 510(k) Modifications Guidance | To clarify which changes do or do not warrant submission of a new 510(k) and which modifications are eligible for a Special 510(k). | Draft Guidance | July 27, 2011 |
| Streamline Guidance and Regulation Development Process | To provide greater clarity, predictability, and efficiency in the guidance and regulation development process. | Post SOPs to FDA Website (PDF) | July 31, 2011 |
| Clinical Trials Guidance | To improve the quality and performance of clinical trials and the application of the least burdensome principle | Draft Guidance | August 15, 2011 |
| Enhance Training | To train new Center staff on core competencies. To train Center staff and industry on: 1) the determination of "intended use"; 2) the determination of whether a 510(k) raises “different questions of safety and effectiveness"; 3) the review of 510(k)s that use “multiple predicates”; 4) the development and assignment of product codes; 5) the interpretation of the “least burdensome” principles; and 6) the appropriate use of consensus standards. | Develop and implement training on core competencies Launched Reviewer Certification Program Press Release | September 6, 2011 |
| Evaluation of Automatic Class III Designation (De Novo) Guidance | To streamline the de novo classification process. | Draft Guidance | September 30, 2011 |
| Continue Integration and Knowledge Management | To improve knowledge management across the Center. | Complete evaluation of methods used to integrate device information into a dynamic format so that it can be more readily used by staff to make regulatory decisions Internal Assessment completed | October 4, 2011 |
| Leverage External Experts | To develop a network of external experts to appropriately and efficiently leverage external scientific expertise. Also, to assess best-practices and develop SOPs for staff engagement with external experts. | Post SOP to FDA Website | October 4, 2011 |
| Multiple Predicate Analysis | To conduct additional analyses to determine the basis for the apparent association between citing more than five predicates and a greater mean rate of adverse event reports. | Complete analysis and make results public | October 14, 2011 |
| 510(k) Paradigm Guidance | To provide greater clarity regarding: 1) when clinical data should be submitted in support of a 510(k); 2) the submission of photographs or schematics for internal FDA use only; 3) the appropriate use of multiple predicates; 4) the criteria for identifying "different questions of safety and effectiveness" and technological changes that generally raise such questions; 5) resolving discrepancies between the 510(k) flowchart and the Food, Drug, and Cosmetic Act; 6) the characteristics that should be included in the concept of “intended use”; and 7) the development of 510(k) summaries to assure they are accurate and include all required information. | Draft Guidance | December 27, 2011 |
| Appeals Guidance | To clarify the process for appealing CDRH decisions by external persons. | Draft Guidance | December 27, 2011 |
| Product Code Guidance | To more consistently develop and assign unique product codes. | Draft Guidance | December 30, 2011 |
| Implement a Unique Device Identification (UDI) System | To permit the rapid and accurate identification of devices, to facilitate and improve adverse event reporting and identification of device-specific problems. | Issue proposed regulation | July 3, 2012 |
| Pre-Submission Interactions Guidance | To supplement available guidance on pre-IDE meetings and enhance the quality of pre-submission interactions between industry and Center staff. | Draft Guidance | July 13, 2012 |
| Clarify and Improve Third-Party Review | To develop a process for regularly evaluating the list of device types eligible for third-party review and to enhance third-party reviewer training. | Post SOP to FDA Website** | February 15, 2013 |
| Standards Guidance | To clarify the appropriate use of consensus standards. | Draft Guidance | Started Due October 31, 2011 |
| Improve Medical Device Labeling | To clarify the statutory listing requirements for the submission of labeling. | Issue proposed regulation | Started Due December 31, 2011 |
| Draft 510(k) Transfer of Ownership Regulation | To better identify 510(k) transfers of ownership. | Issue proposed regulation | Started Due December 31, 2011 |
Additional CDRH Actions Taken in Support of 510(k) and Science Report Recommendations
| Action | Purpose | Milestone/Deliverable | Completion Date |
|---|---|---|---|
| Analysis of Pre-market Review Times Under the 510(k) Program | To determine factors affecting total review time and the number of review cycles. | Post results of the analysis | July 19, 2011 |
| Making Benefit-Risk Determinations in Medical Device Pre-market Review | To provide greater clarity regarding the factors FDA considers when making benefit-risk determinations during the pre-market review process. | Final Guidance Issued March 28, 2012 | August 15, 2011 (Draft Guidance) |
| Corrective and Preventive action (CAPA) system | To assure identification and resolution of pre-market review issues. Corrective actions and, where appropriate, preventive actions, needed to correct identified issue and prevent recurrence of the problem will be recorded in a CAPA system. | Start pilot program Pilot program underway | October 1, 2011 |
| International Device Regulators Forum | To establish a new forum to accelerate international medical device harmonization and convergence. | Hold preparatory meetings with other countries | February 15-17, 2011 October 6-7, 2011 |
Hold first meeting of the forum | Started Due in 2012 | ||
| SOPs for Requesting Additional Information | To provide an SOP that clarifies the level of sign off or concurrence required for requesting additional data for premarket reviews. | Internal SOP with training to staff | November 9, 2011 |
| Early Feasibility Medical Device Clinical Studies Guidance | To provide greater clarity regarding the development and review of Investigational Device Exemptions (IDE) applications for early feasibility studies of significant risk devices, including first-in-human studies, | Draft Guidance | November 10, 2011 |
| IDE Decisions Guidance | To provide clarification regarding the types of decisions FDA may make to approve an IDE and to provide a general explanation of the reasoning and implications of those decisions. To provide an SOP that clarifies the level of sign off or concurrence required for requestion additional data for pre-market reviews. | Draft Guidance | November 10, 2011 |
| Change in Reviewer | To establish procedures to assure greater consistency in the review of pre-market documents (e.g., IDEs, PMAs, 510(k)s) when review staff change during the review. | Internal SOP with training to staff | December 27, 2011 |
| Innovation Pathway | To formally develop and implement the Innovation Pathway for important medical devices and apply new approaches developed to other pre-market pathways | Begin implementing Innovation Pathway 2.0 | April 9, 2012 |
| Triage of Pre-market Submissions | To increase submission review efficiency and better manage the pre-market review workload. The initial management review (triage) will help determine the level of review required for each submission. | Start pilot program Pilot program underway | April 2, 2012 |
| Foreign Clinical Studies | To clarify the circumstances under which we would rely on clinical studies conducted in and for other countries. | Proposed regulation | February 25, 2013 |
* Both actions were discussed at the April 7, 2011.
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