FDA’s Policies, Procedures, and Systems: Effects on Provider and Information

Technology Sectors

Karen M. Becker, Ph.D. and Philip J. Phillips, MBA

Becker & Associates Consulting, Inc.2001 Pennsylvania Avenue NW, Suite 575

Washington, DC 20006www.becker-consult.com

Health TechNet MeetingMay 19, 2006

Offices of Pillsbury Winthrop Shaw Pittman LLPMcLean, VA

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Agenda

• FDA’s Approaches to Regulation

• Current Critical Issues: FDA, Industry, and the Public

• The Future of Hospital Information Systems

• Open Discussion

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FDA’s Approaches to Regulation

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FDA’s Mission1

The Administration shall –1) Promote the public health by promptly and efficiently

reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner;

1. 21 USC §393(b).

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FDA’s Mission (continued)1

2) With respect to such products, protect the public health by ensuring that –• There is a reasonable assurance of the safety and

effectiveness of devices intended for human use;2

3) Participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements; and

1. 21 USC §393(b).2. 21 USC §393(b)(2)(C). Parts (A), (B), (D), and (E) do not relate to medical devices.

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FDA’s Mission (continued)1

4) As determined to be appropriate by the Secretary, carry out paragraphs (1) through (3) in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products.

1. 21 USC §393(b).

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An Inside Perspective

• FDA’s mission statement was added by the FDA Modernization Act (FDAMA) in 1997– Driven by the device industry– To foster consistency in regulation

• The “regulatory pendulum”:– Steady, but poised to move at any time– Politics and public perception initiate the motion

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An Inside Perspective (continued)

• The “state of affairs” at FDA– The “leadership” has few “followers”

• There is a surplus of scientists, clinicians, and managers, but not enough “regulators”

– The result is a great concern with public health, and little consistency, creativity, and/or compassion

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An Inside Perspective (continued)

• Possible explanations include:– Lack of proper incentives– Self-preservation– Risk aversion

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Current Critical Issues: FDA, Industry, and the Public

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A Manageable List

• The impending crisis– “Out with the old” (Attrition)– “In with the new” (Training)

• User fee reauthorization– The need for “meaningful metrics”

• Postmarket surveillance

• Public perception

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The Future of Hospital Information Systems

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Hospital Information Systems

• Currently not regulated by FDA

• Interfacing with medical devices – “the slippery slope”

• Technology and capabilities will drive future regulatory status– If actively regulated in the future, will likely be:

• Under the medical device authorities;• Subject to quality systems requirements (i.e., GMPs); and• Exempt from premarket notification (510(k)).

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Laboratory Information Systems

21 CFR §862.2100 – Calculator/data processing module for clinical use.

a) Identification. A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data.

b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in Subpart E of part 807 of this chapter subject to the limitations in §862.9.

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Open Discussion