CDRH Publishes List of Projects and Guidance Documents Planned for 2013 Completion

| 05 December 2012 | By Alexander Gaffney, RAC, 

It's that time of year-the holidays, yes, but also when companies and agencies are putting the final touches on their planning documents for 2013. The US Food and Drug Administration (FDA) is no exception to this trend, and its Center for Devices and Radiological Health (CDRH) has just published its 2013 Strategic Priorities plan.

Calling the plan a continuation and expansion of its efforts to promote "smart regulation," CDRH said it is reorganizing its plan to better meet its vision of providing US consumers access to "high-quality, safe and effect medical devices of public health importance."

"The primary purpose of CDRH's 2013 Strategic Priorities is to inform the public of some of the most important actions we are committing to implement this year to better understand the direction the Center is heading in and what to expect from us this year," Jeffery Shuren, director of CDRH, wrote. "It is not intended as a comprehensive blueprint of every action the Center may take in the coming months."

2013 may well shape up to be a transformative year for the medical device center. Thanks to the FDA Safety and Innovation Act (FDASIA), a massive piece of legislation passed in July 2012, the center is flush with resources and is in the midst of some big regulatory actions, including the early stages of implementing its Unique Device Identification (UDI) rule.

"We consider implementation of FDASIA to be a top priority for CDRH," Shuren wrote. "However, because the FDA has provided a separate mechanism to inform the public of its efforts to implement FDASIA, we have generally not included actions specifically directed at implementing FDASIA in our 2013 Strategic Priorities."

What the strategic plan does contain is a number of timelines by which the center wants to have certain tasks accomplished, including a huge number of guidance documents and reports likely to be of use to industry.

The following list quotes extensively from FDA's Strategic Priorities plan, and includes all relevant dates by which the center hopes to accomplish certain tasks, as sorted by content areas.

Pre-market Review

• By 30 September 2013, finalize all already issued draft guidance documents identified in the plan of action to strengthen pre-market review, with the exception of the guidance on deciding when to submit a 510(k) for a change to an existing medical device.
• By 31 August 2013, collect public input on deciding when to submit a 510(k) for a change to an existing device, i.e., 510(k) modifications.
• By 31 March 2013, improve management of pre-market review content and processes by incorporating commercial technologies and standardized information management practices.
• By 31 December 2013, launch a pilot with industry for the electronic submission of 510(k)s.

Clinical Trials

• By 30 June 2013, using the Entrepreneurs in Residence (EIR) program, begin a pilot project focused on reducing the time and cost of medical device clinical trials.
• By 30 September 2013, develop policies to facilitate better and more efficient use of existing registries for pre-market studies.
• Healthcare Connectivity and Reimbursement
• By 30 September 2013, publish a report identifying opportunities to foster innovative solutions and technology in a connected health care environment.
• By 30 June 2013, using the Entrepreneurs in Residence (EIR) program, begin a pilot project focused on ways to streamline the regulatory pathway from FDA approval to reimbursement.

Personalized Medicine Program

• By 31 March 2013, issue the companion diagnostics final guidance.
• By 30 September 2013, issue a co-development draft guidance.
• By 30 September 2013, as part of the genomics standards development with the National Institute of Standards and Technology, select and sequence the human DNA and microbial DNA reference materials to support analytical validation of genetic sequencing technologies.

Regulatory Science

• By 30 September 2013, facilitate the development of three Medical Device Innovation Consortium Subcommittees focused on the medical device subsector.
• By 30 September 2013, develop a framework for qualifying medical device development tools (MDDTs).
• By 30 September 2013, modify our horizon scanning system for new and emerging technologies from a periodic to a continuous system and expand public input to better inform regulatory science research prioritization and to better prepare CDRH to address new technologies.
• Radiological Health Program
• By 31 March 2013 issue the final guidance on pediatric X-ray imaging.
• By 30 September 2013 issue draft guidance on computed tomography (CT).

Medical device post-market surveillance

• By 28 February 2013, establish a governance board for the Medical Device Epidemiology Network (MDEpiNet) public-private partnership.
• By 31 January 2013, publish next steps to establish a national system for medical device post-market surveillance, taking into consideration public feedback on the September 2012 proposed strategy and four-day public meeting.
• By 30 September 2013, establish a Center-wide signal management program for the timely evaluation and management of significant post-market signals.
• By 30 June 2012, using the Entrepreneurs in Residence (EIR) program, begin a pilot project focused on ways to strike the right balance between pre-market and post-market evidentiary requirements.

Case for Quality Initiative/ Compliance

• By 30 September 2013, in collaboration with external constituents, identify and publicize systemic practices that are linked to device quality outcomes, including steps that CDRH and external constituents can take to support and adopt these practices.
• By 30 September 2013, publicize two quality-related medical device data analyses, such as trends in the types and root causes of device recalls.
• By 31 December 2013, inform quality-related regulatory decisions through focused discussions with external constituents at two national forums and one local forum.
• By 30 September 2013, launch the Voluntary Compliance Improvement Pilot Program.

Globalization

• By 30 September 2013, in collaboration with foreign regulatory authorities, develop the Medical Device Single Audit Program (MDSAP) Acceleration Plan.
• By 30 September 2013, present the plan for approval by the MDSAP Regulatory Authority Council to allow a MDSAP-recognized auditing organization to perform audits that will meet the needs of multiple regulatory jurisdictions in a pilot program in 2014.

Regulatory Harmonization

• By 30 November 2013, as a member of the Regulatory Product Submission Workgroup, present to IMDRF Management Committee draft Tables of Contents for medical device and vitro medical device for common regulatory submissions.
• By 30 November 2013, as a member of the Unique Device Identification (UDI) Workgroup, present to IMDRF Management Committee a draft IMDRF guidance document on UDI to update the September 2011 Global Harmonization Task Force (GHTF) document entitled "Unique Device Identification (UDI) System for Medical Devices."
• By 30 November 2013, as the chair of the Medical Device Single Audit Program Workgroup, present to IMDRF Management Committee a draft final IMDRF guidance document on the "Recognition Criteria for Medical Device Auditing Organizations."

Labeling

• By 31 December 2012, publish draft guidance on home use medical devices.
• By 30 September 2013, publish a proposed rule to establish an online repository of labeling for home use devices.
• By 30 June 2013, complete study of users of device labeling.
• By 30 June 2013, hold public workshop with multiple stakeholder groups to discuss study findings, an on-line repository, and a standard content and format of device labeling.

Use of Social Media by CDRH

• By 30 April 2013, conduct and evaluate a social media utilization pilot.
• By 30 September 2013, develop and begin to implement a plan for incorporating social media into the CDRH communication process.

FDA Staff engagement

• CDRH recognizes the value of our employees and provides a workplace environment that supports productivity.
• By 30 September 2013, develop and begin to implement a plan to optimize the use of CDRH resources available for learning opportunities and travel.
• By 30 September 2013, develop and begin to implement a plan to improve internal communication, increase transparency and assure that staff are connected to the Center.
• By 30 September 2013, develop and begin to implement a plan to improve the selection and nomination process for CDRH Honors Awards.
• By 30 September 2013, develop and begin to implement a plan to improve staff recognition for good performance and to appropriately address poor performance.