Novartis Flu KitRegulatory Discussion

PresenterOctober XX, 2010

FDA Updates

SARTA MeetingAugust 22, 2012

AGENDA• Review recent FDA changes relevant

to medical devices• Upcoming FDA changes• Discussion and Questions

CDRH Plan of Action for 510(k) and Science

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BackgroundAugust 2010 Reports

» 510(k) Working Group» To evaluate the 510(k) program and explore actions CDRH

could take to enhance the agencies 510(k) decision making» Task Force on the Utilization of Science in Regulatory

Decision Making» To assess the way CDRH uses science in regulatory decision

making and identify steps the agency could take to strike a better balance between these two critical aims

Background

CDRH Plan of Action for 510(k) and Science• 25 specific actions and accompanying timelines

for completion or for reaching a milestone in 2011 • Goal: Make the 510(k) program a blueprint for

smarter medical device oversight; one that drives innovation and brings important technologies to patients

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Three main areas of emphasis

• Create a culture of change toward greater transparency, interaction, collaboration, and the appropriate balancing of benefits and risks;

• Assure predictable and consistent recommendations, decision making, and application of the least burdensome principle; and

• Implement efficient processes and use of resources.

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Update on Implementation and Accomplishments

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Guidance – 510(k) ModificationsMilestone date: June 15, 2011Draft issued: July 27, 2011 – very similar to 1997

version• Purpose of the revision:

» To address issues associated with software and other rapidly changing technologies

» To provide greater clarity about changes that do and do not trigger the need for a new premarket submission

• Prior Vague areas defined:» Changes that “could significantly affect” safety and

effectiveness» Changes to intended use considered “major” causing new

510(k)

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FDA Internal & Administrative MattersLeverage External Experts

» Completed on October 4, 2011

• Develop a network of external experts to appropriately and efficiently leverage scientific expertise

• To assess best-practices and develop SOPs for staff engagement with external experts

• SOP has been posted to FDA websitehttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm271521.htm

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FDA Internal & Administrative MattersEnhance Training• Reviewer certification launched Sept 6, 2011

» 18-month program» All new reviewers required to go through the program» On-line, instructor-led, practical experience» Medical device, FD&C law, regulatory requirements,

CDRH review process, device design, impact of human factors

• Experiential learning program – next to launch» Visits to academic institutions, manufacturers, research

organizations, healthcare facilities

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FDA GuidanceDe Novo Classification Process

Posted to FDA’s website on September 30, 2011Draft Guidance for Industry and Food and Drug Administration Staff - De Novo Classification Process (Evaluation of Automatic Class III Designation)

• Provides route to market for medical devices that are low to moderate risk, but have been classified as class III because FDA has found them to be NSE to legally marketed predicate

• Provides greater clarity about the suitability of a device for the de novo process, and timely input on the type of data necessary to support de novo classification

• When final, this guidance will replace “New Section 513(f)(2) – Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff,” dated February 19, 1998.

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FDA GuidanceFeasibility/First in Human

Posted on FDA Website on November 10, 2011Draft Guidance for Industry and Food and Drug Administration Staff – Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies

• Provides guidance to FDA staff, clinicians, clinical innovators, and industry on development and review of Investigational Device Exemption (IDE) applications for early feasibility studies of significant risk devices.

• Developed to facilitate early clinical evaluation of medical devices in the U.S. under IDE regulations using risk mitigation strategies that appropriately protect human subjects in early feasibility studies.

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FDA GuidanceIDE Decisions

Posted on FDA’s Website on November 10, 2011Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff - FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations

• Provides clarification regarding the regulatory implications of the decisions that FDA may render based on review of an IDE and to provide a general explanation of the reasons for those decisions

• Methods to allow a clinical investigation of a device to begin under certain circumstances, even when there are outstanding issues regarding the IDE submission. These mechanisms, include:» approval with conditions, » staged approval, » communication of outstanding issues related to the IDE through future considerations

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FDA Guidance510(k) Program

Posted to FDA’s website on December 27, 2011Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]

• Provide greater clarity regarding the following;» when clinical data should be submitted in support of a 510(k); » submission of photographs or schematics for internal FDA use only; » appropriate use of multiple predicates; » criteria for identifying "different questions of safety and effectiveness" and

technological changes that generally raise such questions; » Resolving discrepancies between the 510(k) flowchart and the Food, Drug, and

Cosmetic Act; » characteristics that should be included in the concept of “intended use”; and » development of 510(k) summaries to assure they are accurate and include all

required information.

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FDA GuidanceAppeals Guidance

Posted to FDA’s website on December 27, 2011Draft Guidance for Industry and Food and Drug Administration Staff - CDRH Appeals Processes

• Individuals outside of FDA who disagree with a decision or action taken by CDRH and wish to have it reviewed or reconsidered have several processes for resolution from which to choose including requests for supervisory review of an action, petitions; and hearings.

• Provides general information about each process and guidance on how to submit requests

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FDA GuidanceProduct Code

Posted to FDA’s website on December 30, 2011Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Classification Product Codes

• Educates regulated industry and FDA Staff on classification product codes for medical devices regulated by CDRH and CBER.

• Describes how classification product codes are used in a variety of FDA program areas to regulate and track medical devices.

FDA GuidanceBenefit-Risk

Posted on Final Guidance on FDA’s Website on March 28, 2012Guidance 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

• Explains principal factors FDA considers when making benefit-risk determinations in the premarket review of devices subject to PMA or de novo classification petitions.

• Benefit-risk factors should be considered during the design, non-clinical testing, pre-IDE, and IDE phases as well as in assembling and assessing PMA application or de novo petitions.

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FDA GuidancePre-Submission Interactions (Pre-IDE)

Posted to FDA’s website on July 13, 2012Draft Guidance for Industry and FDA Staff Medical Devices: The Pre-Submission Program and Meetings with FDA Staff

• Outlines clear recommendations for sponsors and for FDA staff and managers as well as expected timeframes for scheduling meetings

• Describes procedures CDRH and CBER intend to follow when manufacturers, their representatives, or application sponsors request a meeting with review staff, either as the preferred method of feedback in response to a Pre-Submission, or to discuss to an existing regulatory submission, and recommends how to prepare for meetings with FDA staff.

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FDA GuidanceRefuse to Accept Policy for 510(k)s

Posted to FDA’s website on August 13, 2012Draft Guidance for Industry and Food and Drug Administration Staff – Refuse to Accept Policy for 510(k)s• Updates the CDRH 510(k) Refuse to Accept Policy issued on June

30, 1993 and 510(k) Refuse to Accept Procedures, 510(k) Memorandum K94-1

• Policy modified to include an early review against specific acceptance criteria and to inform the submitter within the first 15 calendar days after receipt if the submission is administratively complete, or if not, to identify the missing elements.

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FDA GuidanceRefuse to Accept Policy for 510(k) (cont.)• FDA staff will answer the preliminary questions

» Based on the answers to the these preliminary questions, the remainder of the acceptance review may or may not be necessary.

» If responses to the questions and consultation with the Center personnel indicate that the 510(k) acceptance review should not continue and reviewer should promptly notify the submitter

• Appendices include Acceptance Checklist for traditional, special or abbreviated 510(k)s» Clarifies the necessary elements and contents of a complete 510(k) submission

• Process applicable to all devices reviewed through the 510(k) notification process

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FDA GuidanceRefuse to Accept Policy for 510(k) (cont.)• FDA encourages all submitters to review the checklists to

incorporate the requirements and also encourages submitters to provide an electronic copy in place of one of the two hard copies of the 510(k) submissions

• Comments and suggestions regarding this draft document may be submitted within 45 days.» Submit written comments to the Division of Dockets Management (HFA-

305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.

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CDRH Transparency

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CDRH Transparency• FDA formed the Transparency Task Force to develop

recommendations for making useful and understandable information about FDA activities and decision making more readily available to the public in a timely manner and in a user-friendly format.

• In support of the Agency’s Transparency Initiative, CDRH launched a Transparency Web site to provide meaningful and timely information about the products it regulates and the decisions it makes. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm199624.htm

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CDRH Transparency – What’s New• Addition of Evaluation of Automatic Class III Designation Decision (de novo)

Summaries to FDA website http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm232269.htm

• Addition of PMA Summary Review Memos for 180-Day Design Changes http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pmamemos.cfm

• Total Product Life Cycle (TPLC) Databasehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm

• The PMA Clinical Trials Database is abstracted from Premarket Approval (PMA) Summaries of Safety and Effectiveness data (SSED).http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm204243.htm

• Investigational Device Exemption (IDE) - Pivotal IDE Description Summary Formhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm205697.htm

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FDA Guidance Documents

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FDA Guidance Acceptance and Filing Review for PMAs

Draft issued July 31, 2012Draft Guidance: Acceptance and Filing Review for Premarket Approval Applications (PMAs)

• Threshold determination whether application is administratively complete prior to substantive review

• Appendices provide checklists for acceptance and filing of PMAs• Acceptance review is 15 calendar days (same as new 510(k) RTA

Policy)• Administrative processes of filing review phase is 45 days:

» Document tracking» Distribution and handling» Assembling the review team» Setting up the filing meeting

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Planned Guidance Documents

• Standards Guidance» To clarify the appropriate use of consensus standards

due October 31, 2011• Interactive Review and other Communications• Other MDUFA-Related Guidance Documents

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Planned OIVD Guidance Documents• Class II Special Controls Guidance Document: Tryptase

Test System• Class II Special Controls Guidance Document: Dengue

Virus Serological Reagents• Establishing the Performance Characteristics of In

Vitro Diagnostic Devices for the Detection of methicillin-resistant Staphylococcus aureus (MRSA) for Culture Based Devices (Final)

• Finalization of any drafts that were published in the last couple of years

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MDUFA III

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MDUFA III

• Medical Device User Fee Amendments 2012 (MDUFA III)» Take effect on October 1, 2012 and will sunset in five

years on October 1, 2017» Represents a commitment between the US Medical

device industry and the FDA to increase efficiency of regulatory processes in order to reduce the time it takes to bring safe and effective medical devices to the U.S. Market

» The FDA is authorized to collect user fees that will enable FDA to hire more than 200 full-time-equivalent workers

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MDUFA III» Process improvements that will help achieve MDUFA III

» Improved Pre-Submission ProcessThe FDA will introduce a more structured approach to address product-specific questions regarding review issues for PMAs, 510(k)s and Investigational Device Exemptions (IDEs)

» Submission Acceptance CriteriaThe FDA will implement revised submission acceptance criteria through guidance. 

» Interactive reviewThe Agency will continue to incorporate an interactive review process to provide for, and encourage, informal communication between FDA and applicants to facilitate timely completion of the review process based on accurate and complete information.

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MDUFA III» Process improvements that will help achieve MDUFA III

(cont.)» Guidance Document Development

FDA will apply user fee revenues to supplement the improvement of the process of developing, reviewing, tracking, issuing, and updating guidance documents. FDA will update its website in a timely manner to reflect the following: 1. The Agency’s review of previously published device guidance

documents, including the deletion of guidance documents that no longer represent the Agency’s interpretation of, or policy on, a regulatory issue, and notation of guidance documents that are under review by the Agency;

2. A list of prioritized device guidance documents (an “A-list”) that the Agency intends to publish within 12 months of the date this list is published each fiscal year; and

3. A list of device guidance documents (a “B-list”) that the Agency intends to publish, as the Agency’s guidance-development resources permit each fiscal year.

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MDUFA III» Guidance Document Development (cont.)

The Agency will establish a process allowing stakeholders an opportunity to: 1. Provide meaningful comments and/or propose draft language for

proposed guidance topics in the “A” and “B” lists. 2. Provide suggestions for new or different guidance documents; and 3. Comment on the relative priority of topics for guidance.

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MDUFA III» Process improvements that will help achieve MDUFA III

(cont.)» Third-Party Review

MDUFA III authorizes the third-party review program.

» Patient Safety and Risk ToleranceFDA will fully implement final guidance on the factors to consider when making benefit-risk determinations in medical device premarket review.

» Low Risk Medical Device ExemptionsBy the end of FY 2013, FDA will propose additional low risk medical devices to exempt from premarket notification. Within two years of such proposal, FDA intends to issue a final rule exempting additional low risk medical devices from premarket notification.

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MDUFA III» Process improvements that will help achieve MDUFA III

(cont.)» Emerging Diagnostics

FDA will work with industry to develop a transitional In Vitro Diagnostics (IVD) approach for the regulation of emerging diagnostics.

» Performance goals – Staffing & Training and TrackingUser fees will provide the FDA with additional resources to recruit, train, and retain employees with the expertise needed to meet these goals, and additional resources to update the agency’s information technology systems to facilitate meeting those performance goals. 

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Reorganization

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Reorganization

• Proposed OIVD Reorganization beginning FY2013» Office of In Vitro Diagnostics and Radiological Health

(OIR)» Division of Chemistry and Toxicology (DCTD), Division of

Immunology and Hematology (DIHD), Division of Microbiology (DMD), Division of Program Operations and Management (DPOM), Division of Radiological Health (DRH) and Division of Mammography Quality Standards (DMQS)

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Reorganization

• Adding branches» Consistent with the rest of the Center

• Adding Post-market Radiology• Adding all Radiological Health• Adding Mammography Quality Standards Act and

Program

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Reorganization

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Discussion and Questions

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Accomplishments

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Accomplishments

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Accomplishments

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Accomplishments

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Accomplishments

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Accomplishments

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