• User fees and performance goals for premarket reviews of PMAs, PDPs, premarket reports (a new category of premarket application for reprocessed single-use devices), certain supplements, and 510(k)s. These fees, together with additional appropriations, are intended to allow FDA to make significant improvements to review evaluation processes, reducing the time required to make new medical technologies available to health care professionals and patients.
• Establishment inspections may be conducted by accredited persons (third-parties), under carefully prescribed conditions.
• New regulatory requirements for reprocessed single-use devices, including a new category of premarket submission, the premarket report.  

These and other important provisions of MDUFMA affect many aspects of various CDRH and OHIP programs.

OHIP's Responsibilities

During FY 2003, OHIP provided extensive support to CDRH stakeholders and staff to implement the many provisions of MDUFMA. These included:

• Stakeholder Education and Training: MDUFMA provides for the education and training of stakeholders and requires that FDA hold an annual stakeholder meeting. During FY, 2003, OHIP created the MDUFMA website; developed summary materials for the public regarding MDUFMA; provided a “User Fee Teleconference” in April 2003; mailed a letter on the new User Fees to 30,000 medical device establishments; and, prepared for the First Annual Stakeholder Meeting that will take place in December 2003.

• Regulations and Guidance: In order to assure timely implementation of the MDUFMA requirements, OHIP provided extensive support for regulations and guidance development. Fifteen guidance documents were drafted under MDUFMA to provide staff and stakeholders with needed information and instructions. All MDUFMA deadlines have been met.

• Science Education: In order to provide CDRH staff with the information and skills needed to meet MDFUMA goals, OHIP provided 44 scientific courses on diverse technical areas. There were more than 1,000 attendees at the courses (individual CDRH staff members may have attended more than one course).

• Small Business Determinations: MDUFMA mandated that medical device manufacturers must now pay a fee for each premarket application (PMA), premarket report, PMA supplement, or 510(k) submitted for review, unless they are eligible for a waiver or exception. Establishments that meet requirements for FDA designation as a “Small Business” pay a reduced or waived fee. OHIP established and administers the program for making the small business determination under MDUFMA. In FY’03, 135 Small Business Determinations were made between March 5 and September 30, 2003. Of these, there were 10 denials.

• MDUFMA Third Party Inspections: The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) was signed into law by the President on October 26, 2002. Section 201 of MDUFMA establishes a new subsection "g" to section 704 (Factory Inspection) of the act, which requires FDA to accredit third parties (Accredited Persons, a.k.a. APs) to perform inspections of eligible manufacturers of Class II or III devices. MDUFMA requires the agency to publish in the Federal Register, not later than 180 days after the date of enactment, criteria to accredit or deny accreditation to persons who request to perform the duties of an AP.

These criteria were published in the Federal Register on April 28, 2003 at 68 FR 22400 and in the guidance "Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria."

During FY 2003, OHIP received 23 AP applications from 22 organizations. Because MDUFMA limits the number of APs to 15 in the first year, we prepared a “Rating and Ranking” checklist to assist in evaluation of the AP applications. After acceptance of the applications as well as formal classroom training and joint training inspections with the FDA, the approved APs will be able to conduct inspections in early FY 2004.

• Accredited Persons (AP) 510(k) Reviewer Program: The Accredited Persons Program was created by the FDA Modernization Act of 1997 (FDAMA), based on an FDA pilot. The purpose of the program is to improve the efficiency and timeliness of FDA's 510(k) process, the process by which most medical devices receive marketing clearance in the United States. Under the program, FDA has accredited third parties (Accredited Persons) that are authorized to conduct the primary review of 510(k)'s for eligible devices. Persons who are required to submit 510(k)s for these devices may elect to contract with an Accredited Person and submit a 510(k) directly to the Accredited Person. The Accredited Person conducts the primary review of the 510(k), then forwards its review, recommendation, and the 510(k) to FDA. By law, FDA must issue a final determination within 30 days after receiving the recommendation of an Accredited Person. 510(k) submitters who do not wish to use an Accredited Person may submit their 510(k)'s directly to FDA.

In an effort to encourage greater use of the Accredited Persons Program, FDA implemented an expansion pilot in January 2001 that allows Accredited Persons to review many Class II devices that were not previously eligible. The pilot allows, subject to certain conditions, Accredited Persons to review Class II devices for which there are no device-specific guidance documents. Information on the expansion pilot, including criteria allowing for the review of these Class II devices, can be found in a guidance document entitled, Guidance for Staff, Industry and Third Parties: Implementation of Third Party Programs Under the FDA Modernization Act of 1997.

This guidance is a revision of the October 30, 1998 guidance document with the same title. Accredited Persons and other interested parties should refer to Section II.B., Purpose and Nature of the Program, for the criteria that would allow for the review of the Class II devices in the expansion pilot.

During FY 2002, 510(k)'s reviewed by Accredited Persons received FDA marketing clearance in an average of 77 days after initial receipt by the Accredited Person — 29% faster than comparable 510(k)'s reviewed entirely by FDA. In addition, submissions reviewed by Accredited Persons are not subject to FDA user fees, while 510(k)'s sent directly to FDA are subject to a fee of $2,187 in fiscal year 2003.

Most Accredited Persons have specialized expertise in areas that may be helpful to 510(k) submitters, such as device testing, standards, or foreign regulatory requirements. Further, Accredited Persons have headquarters throughout the United States, in Europe, and in Taiwan, and have additional offices elsewhere, so they often can provide local service.