Among CDRH’s 2013 strategic priorities are plans to launch a pilot for companies to submit electronic 510(k)s, to issue a report identifying opportunities for fostering a “connected health care environment,” and to start implementing a plan for incorporating social media into the center’s communication with industry and others.

These are among the less expected components of the device center’s plans for the year, issued formally Dec. 4. Also, as expected, CDRH says it will finalize all remaining draft guidance documents that are associated with its 2011 “plan of action,” including a comprehensive guideline on how the agency interprets the 510(k) substantial equivalence standard. (See Also see "Changing The Paradigm: 510(k) Draft Guidance May Raise New Questions" - Medtech Insight, 9 January, 2012..)

The only exception to this pledge is for the center’s policy on when a company needs to submit a new 510(k) for a device modification. CDRH withdrew a 2011 draft guidance on that subject (intended to replace 1997 guidelines) in response to severe pushback from industry and Congress.

According to the FDA Safety and Innovation Act, the center needs to submit a report to Congress before issuing a new draft guidance. (See Also see "FDA Subject To More Oversight Following User Fee Bill Passage" - Medtech Insight, 2 July, 2012..) CDRH has now set a goal of Aug. 31 to collect public input on how to approach the 510(k) modifications policy.

The device center has also prioritized the efforts of the second phase of its entrepreneurs-in-residence program. As “The Gray Sheet” reported in October, outside policy, business and clinical experts are working with in-house agency staff to come up with creative approaches to streamlining clinical trials; streamlining the approval-to-reimbursement pathway for devices; and better utilizing post-market data in the pre-market setting. (See Also see "CDRH Entrepreneurs Take Two: Streamlining Data Collection And The Path To Reimbursement" - Medtech Insight, 22 October, 2012..)

CDRH is aiming to launch pilot projects in each of those areas by June 30, based on output from the entrepreneur teams.

The center’s strategic priorities for next year also emphasize its ongoing “Case for Quality” initiative, focused on enhancing manufacturers’ approaches to quality assurance. (See [A#01120730001].) And there is also significant attention paid to global harmonization. (See Also see "With Transition To IMDRF, Focus Shifts To Convergence On Discrete Regulatory Practices" - Medtech Insight, 26 November, 2012..)

One core set of efforts not included on the strategic priority list is implementation of the provisions of the reauthorized user fee agreement and other elements of the FDA Safety and Innovation Act.

User fee implementation is a “well-understood priority,” said CDRH Director Jeffrey Shuren in an introduction to the priorities list.

“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.”

Select CDRH 2013 Strategic Priorities

Goal

Completion Date

Priority 1: Patients in the U.S. have access to high-quality, safe and effective medical devices of public health importance first in the world.

Finalize all already issued draft guidance documents identified in the plan of

action to strengthen pre-market review, with the exception of the 510(k) modifications guidance.

Sept. 30, 2013

Collect public input on deciding when to submit a 510(k) for a modification to an existing device.

Aug. 31, 2013

Launch a pilot with industry for the electronic submission of 510(k)s.

Dec. 31, 2013

Using the entrepreneur-in-residence program, begin a pilot project focused on reducing the time and cost of medical device clinical trials.

June 30, 2013

Publish a report identifying opportunities to foster innovative solutions and technology in a connected health care environment.

Sept. 30, 2013

Using the entrepreneur-in-residence program, begin a pilot project focused on ways to streamline the regulatory pathway from FDA approval to reimbursement.

June 30, 2013

Issue the companion diagnostics final guidance.

March 31, 2013

Issue a co-development drug/diagnostic draft guidance.

Sept. 30, 2013

Priority 2: The U.S. is the world’s leader in regulatory science, medical device innovation and manufacturing, and radiation-emitting product safety.

Facilitate the development of three Medical Device Innovation Consortium Subcommittees focused on the medical device subsector.

Sept. 30, 2013

Issue the final guidance on pediatric X-ray imaging.

March 31, 2013

Issue draft guidance on computed tomography.

Sept. 30, 2013

Priority 3: U.S. post-market surveillance quickly identifies poorly performing devices, accurately characterizes real-world performance, and facilitates device approval or clearance.

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.

Jan. 31, 2013

Establish a Center-wide signal management program for the timely evaluation and management of significant post-market signals.

Sept. 30, 2013

Using the entrepreneur-in-residence program, begin a pilot project focused on ways to strike the right balance between pre-market and post-market evidentiary requirements.

June 30, 2013

Priority 4: Devices are legally marketed in the U.S. and remain safe, effective and of high-quality.

Publicize two quality-related medical device data analyses, such as trends in the types and root causes of device recalls.

Sept. 30, 2013,

Inform quality-related regulatory decisions through focused discussions with external constituents at two national forums and one local forum.

Dec. 31, 2013,

Develop the Medical Device Single Audit Program Acceleration Plan and present the plan for approval by the MDSAP Regulatory Authority Council to allow an MDSAP-recognized auditing organization to perform audits that will meet the needs of multiple regulatory jurisdictions in a pilot program in 2014.

Sept. 30, 2013

Present to the International Medical Device Regulators Forum Management Committee a draft guidance document on unique device identifiers

Nov. 30, 2013

Priority 5: Consumers, patients, their caregivers and providers have access to understandable science-based information about medical devices and use this information to make health care decisions.

Publish draft guidance on home use medical devices.

Dec. 31, 2012

Publish a proposed rule to establish an online repository of labeling for home use devices.

Sept. 30, 2013

Complete study of users of device labeling.

June 30, 2013

Develop and begin to implement a plan for incorporating social media into the CDRH communication process.

Sept. 30, 2013

Priority 6: Strengthen work force and workplace

Develop and begin to implement a plan to improve internal communication, increase transparency and assure that staff are connected to the Center.

Sept. 30, 2013

Source: FDA

CDRH Sets 2013 Strategic Priorities

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