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 Pennsylvania Avenue NW, Suite 575 Washington, DC Health TechNet Meeting May 19, 2006 Offices of Pillsbury Winthrop Shaw Pittman LLP McLean, VA

BECKER, INC. 2 Agenda FDA’s Approaches to Regulation Current Critical Issues: FDA, Industry, and the Public The Future of Hospital Information Systems Open Discussion

BECKER, INC. 3 FDA’s Approaches to Regulation

BECKER, INC. 4 FDA’s Mission 1 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).

BECKER, INC. 5 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) USC §393(b)(2)(C). Parts (A), (B), (D), and (E) do not relate to medical devices.

BECKER, INC. 6 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 USC §393(b).

BECKER, INC. 7 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

BECKER, INC. 8 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

BECKER, INC. 9 An Inside Perspective (continued) Possible explanations include: –Lack of proper incentives –Self-preservation –Risk aversion

BECKER, INC. 10 Current Critical Issues: FDA, Industry, and the Public

BECKER, INC. 11 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

BECKER, INC. 12 The Future of Hospital Information Systems

BECKER, INC. 13 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)).

BECKER, INC. 14 Laboratory Information Systems 21 CFR § – 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.

BECKER, INC. 15 Open Discussion