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The Medical Device User Fee and Modernization Act of 2002 -- “MDUFMA” Overview of Key Provisions

The Medical Device User Fee and Modernization Act of 2002 -- “MDUFMA” Overview of Key Provisions. Michael A. Swit, Esq. Law Offices of Michael A. Swit mswit@fdacounsel.com. Background. Two bills in Congress – both introduced by James Greenwood (R-Pa.)

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The Medical Device User Fee and Modernization Act of 2002 -- “MDUFMA” Overview of Key Provisions

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  1. The Medical Device User Fee and Modernization Act of 2002 -- “MDUFMA”Overview of Key Provisions Michael A. Swit, Esq. Law Offices of Michael A. Swit mswit@fdacounsel.com

  2. Background • Two bills in Congress – both introduced by James Greenwood (R-Pa.) • H.R. 3580 – “Medical Device Amendments of 2001” • H.R. 5651 – “MDUFMA” • Signed by President on 10/26/02 • Public Law 107-250

  3. User Fees • Title I of MDUFMA = User Fees • Adds new §§ 737, 738, et seq., of Federal Food, Drug, and Cosmetic Act • On or after 10/1/02, types of submissions triggering full fees for the submitter: • PMA • “Premarket Report” – i.e., a report under 515(c)

  4. User Fees … • Submissions Triggering Full User Fees: • “Panel Track Supplement” – i.e., one that requests: • either: • a significant change in design or performance of device, • or a new indication for use; and • for which clinical data are generally necessary to provide a reasonable assurance of safety and effectiveness

  5. User Fees … • Submissions Triggering Full User Fees: • “Efficacy Supplement” • Definition: a supplement to an approved premarket application under section 351 of the Public Health Service Act that requires substantive clinical data

  6. User Fees … • “Partial Fees” – types of submissions: • “180-day Supplement” – • Definition -- § 738 – one that requests a significant change in components, materials, design, specification, software, color additives, or labelingBUTIs not a panel-track supplement • Fee amount – 21.5% of fee for a full PMA – or $33,110

  7. User Fees … • “Partial Fees” – types of submissions: • “Real-Time Supplement” • Definition – a supplement requesting a minor change to the device such as to the design of the device, software, manufacturing, sterilization or labelingandWhere applicant has requested – and FDA granted – a meeting or similar forum to jointly review the status of the supplement • Fee amount – 7.2% of PMA fee -- $11,088

  8. User Fees … • 510(k)s – 1.42% of PMA fee or $2,186.80 • Exempt Submissions – no fees!! • “Humanitarian Use Devices” – • Biologic devices where the application seeks to get a license providing “for further manufacturing use only”

  9. User Fees … • Exempt Submissions – no fees!! … • Filings by state, local or federal governmental bodies. • 510(k)’s submitted for third-party review • pediatric use only filings – must be “solely” for pediatric labeling • later “adult” filings – must pay appropriate fee

  10. User Fees … • Logistics • Payment-- due on submission (if you filed between 10/1 and 10/26, you will be billed • Amounts – set by HHS going forward, except for FY 2003, where Congress set the PMA user fees as $154,000

  11. User Fees … • Logistics … • Refunds – • “refused for filing” – get back 75% • application withdrawn before “filing decision” – get back 75% • application withdrawn before first FDA action – FDA “may return some or all of fee” based on “level of effort” FDA already expended • must request within 180 days of original fee due date

  12. User Fees … • Small businesses – may be entitled to a waiver or reduction in fees • definition -- < $30 MM in sales • amount of reduction – • PMA -- 38% of normal fee (= $58,520) • 510(k) – 80% of normal fee (= $1,749) – but, does not apply in FY 2003 • Note – FDA, in 11/21/02 FR notice, includes affiliate sales in calculating $30 mm “small” cutoff – is consistent with MDUFMA • Need to file certified tax returns to qualify

  13. User Fees … • Targets for FY Gross Fee Revenues • 2003 -- $25,125,000 • 2004 -- $27,255,000 • 2005 -- $29,785,000 • 2006 -- $32,615,000 • 2007 -- $35,000,000

  14. User Fees … • What if you don’t submit? • Application will be considered incomplete and shall not be accepted for filing • Other Requirements Under MDUFMA Title I: • §103 – Annual reports to Congress on FDA progress toward meeting performance goals in the “letters”

  15. User Fees … • Other Title I Requirements … • §104 – additional appropriations for post-market surveillance – • 2003 – an increase of $3 MM • 2004 – an increase of $6 MM • Study on various aspects of FDA’s ability to conduct postmarket surveillance • Study Report – Due Jan. 10, 2007

  16. User Fees … • Other Title I Requirements … • §105 – “Consultation” – relative to reauthorization after FY 2007, the Secretary is to consult with: • House Energy & Commerce Cmte. • Senate Health, Ed., Labor & Pensions Cmte • “scientific and academic experts, health care professionals, reps of patient and consumer advocacy groups” and • regulated industry

  17. User Fees … • Other Title I Requirements … • §106 – Effective Date – 10-26-02, but applies to filings made between 10-1 and 10-26 • §107 – Sunset – midnight on September 30, 2007. • §738(g) – “Early Sunset” aka “Eclipse” provisions – complicated formula; if FDA doesn’t meet goals, early sunset after FY 2005

  18. User Fees … • FDA Implementation – 11/21/02 Federal Register – 67 Fed. Reg. 70228 • lays out fees • FDA can’t collect until there are “enabling appropriations” • Interim procedures:

  19. Title II – Selected Key Amendments on Medical Devices • §204 – “Combination Products” -- Amends §503(g) of the Act to: • Establish, at the Commissioner’s office level, an office on Combination Products • Office duties: • to promptly assign FDA “Center” with “primary jurisdiction” to the product • note: “primary jurisdiction” not changed • coordinate reviews among centers • ensure consistency among similar reviews • Annual report to Congress on implementation

  20. Title II – Amendments re Regulation of Medical Devices … • §205 – “Report on Certain Devices” – by 10/26/03, Secretary to report to Congress on “the timeliness and effectiveness of device premarket reviews by centers other than [CDRH]…” • detailed logs • recommendations on how to improve

  21. Title II – Amendments re Regulation of Medical Devices … • §209 – “Modular Review” – amends §515(c) of Act to formalize the modular review process. • Note – is a permanent change to FFDCA; however, is not applicable if fees are not being collected due to either: • Eclipse under §738(g); or • Full sunset after FY 2007 (i.e., no reauthorization)

  22. Title II – Amendments re Regulation of Medical Devices … • §210 – Pediatric Expertise Regarding Classification-Panel Review of Premarket Applications – amends §515(c) of FFDCA to require that, “where appropriate”, panels include or consult with “pediatric experts.” • §212 – IOM Study on Postmarket Surveillance re Pediatric Populations – study to see if system “provides adequate safeguards” on device use in pediatric populations. • will include focus on implanted devices • Congressional report of study due in 4 years

  23. Title II – Amendments re Regulation of Medical Devices … • §213 – Guidance on Pediatric Devices – within 270 days of enactment, Secretary “shall issue” guidance on: • type of information necessary to provide reasonable assurance of the safety and effectiveness of medical devices intended for pediatric use; and • protections of pediatric subjects in clinical investigations of the safety or effectiveness of such device.

  24. Questions? Call, e-mail, fax or write:Michael A. Swit, Esq. Law Offices of Michael A. Swit 539 Samuel Ct., Suite 229 Encinitas, California 92024 760-815-4762 ♦ 760-454-2979 (fax) mswit@fdacounsel.com http://www.fdacounsel.com

  25. About the speaker ... Michael A. Swit has extensive experience in all aspects of FDA regulation with a particular emphasis on drugs and medical device regulation. In addition to his regulatory law experience, Mr. Swit also served for three and a half years as vice president and general counsel of Pharmaceutical Resources, Inc. (PRI) a prominent generic drug company and, thus, brings an industry and commercial perspective to his representation of FDA-regulated companies. While at PRI from 1990 to late 1993, Mr. Swit spearheaded the company’s defense of multiple grand jury investigations, other federal and state proceedings, and securities litigation stemming from the acts of prior management. Mr. Swit then served from 1994 to 1998 as CEO of Washington Business Information, Inc. (WBII) a premier publisher of FDA regulatory newsletters and other specialty information products for the FDA publishing company. Before starting FDACounsel.com, he was with Heller Ehrman from May 2001 to May 2003, and also twice in private practice with McKenna & Cuneo, from 1988 to 1990 and, most recently, from 1999 to 2001, first in that firm’s D.C. office and most recently, in its San Diego office. He first practiced FDA regulatory law with the D.C. office of Burditt & Radzius from 1984 to 1988. Mr. Swit has taught and written on a wide variety of subjects relating to FDA law including, since 1989, co-directing a three-day intensive course on the generic drug approval process, serving on the Editorial Board of the Food & Drug Law Journal, and editing a guide to the generic drug approval process, Getting Your Generic Drug Approved, published by WBII. Mr. Swit holds an A.B., magna cum laude, with high honors in history, in 1979, from Bowdoin College, and earned his law degree from Emory University in 1982. He is a member of the California, Virginia and District of Columbia bars. FDACounsel.com

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