During FY 2009, FDA continued to make good progress in meeting its negotiated performance goals. FDA worked with stakeholders to improve communication and understanding of MDUFMA requirements and to ensure that its implementation accomplishes MDUFMA objectives. The performance gains and improved predictability in review processes achieved since medical device user fees were enacted in 2002 are providing significant benefits to industry, healthcare professionals, and patients. Among the key activities and accomplishments during FY 2009 were:
Steady progress in meeting medical device performance goals. FDA’s overall performance for the FY 2003 through FY 2007 receipt cohorts indicates FDA is meeting or exceeding most MDUFMA I performance goals. FDA’s performance for MDUFMA II has been mixed. In evaluating the pending performance for new FY 2008 performance goals, FDA has already achieved its 510(k) and PMA real-time and 180-day supplement goals.
FDA was not able to meet its PMA Modular goals in FY 2009. This was a new goal for the agency in FY 2008. Through improved incorporation of the PMA Modular goal into the business process of premarket review the agency believes it may meet its PMA Modular goals in FY 2010.
It is unlikely FDA will meet its PMA and panel track PMA supplement goal. Some of the challenges include: the incorporation of new PMA goals, such as PMA Modules and PMA Real-Time supplements, new interactive review goals, and maintenance of current performance (e.g. Investigational Device Exemptions (IDEs), pre-IDEs, 30-day notices, and specials). FDA will continue to evaluate the PMA performance.
Guidance Documents. During FY 2009, FDA issued 15 guidance documents that relate to MDUFMA —
- Guidance for Industry, FDA, and Foreign Governments: FY 2010 Medical Device User Fee Small Business Qualification and Certification. This guidance was required by section 212 of FDAAA.
- Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria. This guidance was required by section 228 of FDAAA.
- Guidance for Industry and FDA Staff - User Fees and Refunds for Premarket Notification Submissions (510(k)s).
- Procedures for Handling Post-Approval Studies Imposed by PMA Order – 06/16/09.
- Draft Guidance for Industry and FDA Staff: Investigational Device Exemption (IDE) Guidance for Retinal Prostheses – 04/17/09.
- Draft Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications — 3/13/2009.
- Guidance for Industry and FDA Staff: Recommendations for Anti-Nuclear Antibody (ANA) Test System Premarket (510(k)) Submissions — 1/22/2009.
- Guidance for Industry: Designation of Special Controls for Male Condoms Made of Natural Rubber Latex — 1/5/2009.
- Draft Guidance for Industry and FDA Staff: Assay Migration Studies for In Vitro Diagnostic Devices — 1/5/2009 — Required by paragraph I.O.1.(c) of the FDA commitment letter.
- Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA — 1/2/2009 — Required by paragraph I.O.1.(e) of the FDA commitment letter.
- Guidance for Industry and FDA Staff: Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use — 12/24/2008.
- Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 — 12/23/2008.
- Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Expander — 12/22/2009.
- Draft Guidance for Industry and FDA Staff: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile — 12/12/2008.
- Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process — 12/11/2009.
• Stakeholder communication and consultation. During FY 2009, FDA’s consultations with stakeholders focused on implementation of the Medical Device User Fee Amendments of 2007 (Title II of FDAAA), including the new user fees and performance goals for FY 2008 thorough FY 2012.
• Reports to Congress during FY 2009. During FY 2009, FDA submitted three annual reports required by MDUFMA to Congress —
- FY 2008 MDUFMA Performance Report,
- FY 2008 MDUFMA Financial Report, and
- FY 2006 Office of Combination Products Report.
FDA also submitted one topical report required by the 2007 amendments:
- A report on labeling of indoor tanning devices concerning the relationship between the use of such devices and development of skin cancer or skin damage.