Originally published December 1995
In a display of unity, three leading medical device industry groups have reached a consensus on FDA reform goals and have sent it to Congress in the form of draft legislation. The proposal, submitted as the Medical Device Reform Act of 1995, was developed by the Health Industry Manufacturers Association (HIMA; Washington, DC), the National Electrical Manufacturers Association (NEMA; Washington, DC), and the National Medical Device Coalition (NMDC; Washington, DC) over several months of discussion. The draft legislation arrived in the hands of key congressional members on October 12.
The legislation provides a detailed blueprint for reforming the agency, a process that the industry groups believe will enhance the competitiveness of U.S. device manufacturers and place medical technologies in the hands of U.S. consumers more rapidly. "We believe the reforms outlined in this legislation will help stem the outflow of innovative medical device products and jobs that are now moving offshore," says Alan Magazine, president of HIMA.
The industry proposal comprises a number of specific reform measures. One involves articulating a mission for the agency that emphasizes the enhancement of public health while deemphasizing enforcement. According to the draft, "A goal of [FDA] must be to ensure that the citizens of the United States receive this country's finest medical technology at the same time or before persons from other countries."
The draft legislation would require FDA to recognize applicable national and international consensus standards. The legislation would also create product review exemptions for devices that pose the least risk to patients. Under section 3, Class I devices would be exempt from the 510(k) requirement, and a regulatory process would be established for exempting Class II devices without the need to reclassify them. In an attempt to abolish the much-criticized reference list, FDA would be prohibited from delaying a 510(k) on the basis of a company's failure to comply with the agency's good manufacturing practices (GMP) regulation.
The section covering premarket notification provides one of the only instances in which a basic disagreement among the groups makes its way into the structure and language of the draft legislation. The major points of this section--510(k) exemptions, eliminating the reference list--reflect a consensus, but the draft then gives lawmakers two options to choose from. The HIMA and NEMA option would require FDA to review a 510(k) submission in 90 days or inform the submitting company of the need for additional time--in writing and with an expected completion date.
The NMDC option, on the other hand, would delete from the law the requirement that FDA issue an order before a product can be legally marketed. Under its alternative, if FDA did not find a device "not substantially equivalent" within 90 days, the company could proceed to deliver the device into interstate commerce. According to Larry Pilot of the law firm McKenna & Cuneo (Washington, DC), this option would restore the premarket notification concept that was in place from 1976 to 1990. Pilot serves as legal counsel to the Medical Device Manufacturers Association, one of the 10 industry groups that constitute NMDC.
Like premarket notification requirements, the premarket approval (PMA) process would be amended under the legislation to help move products out of the regulatory queue and into the hands of U.S. consumers. To achieve this end, the industry legislation would allow companies to use accredited third parties for 510(k) and PMA reviews and for GMP inspections. It would also expand the availability of investigational device exemptions beyond the requirement that a device address a life-threatening or "irreversibly debilitating" disease.
Although one might expect that the degree of compromise needed to hammer out a near-industrywide position would make for a fragile coalition, MDMA's Pilot disagrees. "I think there were only two major points of contention during the negotiation. One was the status of the Center for Devices and Radiological Health within FDA, which NMDC and NEMA clashed over. The other was the 'order' issue with respect to premarket notification, which was solved by including one option from NEMA and HIMA and another from NMDC. In all other instances, the parties involved seemed to recognize the contribution that the discussion and the resulting compromises were making to the public good."
The consensus proposal was given to key congressional members, including Senator Nancy Kassebaum (R-KS), chairwoman of the Senate Labor and Human Resources Committee, and Congressman Thomas Bliley (R-VA), chairman of the House Commerce Committee.
For a copy of the draft legislation, contact Beverly Ross of HIMA at 202/433-7262, Robin Wiley of NEMA at 202/457-8414, or Jeffrey Kimbell of NMDC at 202/898-5700.
(This article originally appeared in the December 1995 issue of Medical Device & Diagnostic Industry. © 1995 CanonCommunications, Inc. All rights reserved.)