The “De Novo” 510(k) Process and the Reclassification of Class III Devices

1. The “De Novo” 510(k) Process and the Reclassification of Class III Devices Medical Device Manufacturers Association 510(k) WorkshopBurlington, Massachusetts September 30, 2005 Michael A. Swit, Esq.Vice President, Life Sciences

2. Whence “De Novo”?? • Device Amendments of 1976 --if not pre-amendment or substantially equivalent (SE), a newly-introduced device automatically placed in Class III • Problems of Automatic Class III Status -- • PMA route mandated -- but many devices did not warrant expense or time • PMA for these devices may not reflect risk 2

3. Whence “De Novo”? • PMA route is procedurally unwieldy-- • FDA -- first must issue rule officially classifying product • Then -- separate rule requiring submission of PMA • PMAs are substantively daunting -- clinical studies raise expense • Automatic Class III Status May Indirectly Cause SE Drift -- firms trying to plug a newpeg into an old hole to avoid PMA route 3

4. An “Answer” to Automatic Class III Status -- FDAMA • Devices Center-- began to address issue in “re-engineering” -- which re-focused the agency on using risk as linchpin of regulatory decisions • Congressional Solution -- § 207 of the 1997 Food & Drug Administration Modernization Act (FDAMA) -- “Evaluation of Automatic Class III Designation” 4

5. An Answer ... • Legislative History-- “instructs the agency to limit consideration to lower risk devices” found to be NSE. [source: FDA 2/98 Guidance on 513(f)(2)] • When eligible -- • 510(k) submitted • not previously classified • found to be NSE • request under 513(f)(2) due within 30 days of receipt of NSE determination 5

6. An Answer ... • The Request for Evaluation of Automatic Class III Designation • describe the device • recommendation (if any) as to classification • reasons for Class recommended • identify risks and benefits of device • the controls (general and/or special) to apply to the device 6

7. An Answer ... • The Request ... • If recommending Class I, include info whether device should be exempt from: • 510(k) • Design Controls • If recommending Class II, include info on the special controls to govern • Any available data on human experience 7

8. An Answer ... • FDA Review of Request • has 60 days to review and reply • may go to an Advisory Panel (in 60-day period) • may request additional info -- if you don’t reply in 30 days, “FDA will maintain the device in Class III” (see 2/98 Guidance, p. 4) • will also consider info in the original 510(k) • Final action -- by written order (may be in form of letter) classifying the device 8

9. How the “Old” Reclassification Petition Differs • Don’t need to have filed a 510(k) •  -- Also don’t need NSE determination • No time limit from an NSE finding • “Old” petition -- see 21 CFR 860.134 9

10. The Agency’s Conclusion “The Center for Devices and Radiological Health believes that the Evaluation of Automatic Class III Designation can be useful for certain low risk devices that have no predicate” See 2/98 Guidance, p. 5 (emphasis added) 10

11. Questions Not Yet Answered (or clearly): • Must the device be “low risk”? • Is the agency applying consistent with law and legislation? • Do you want to recommend the class for your device (you don’t have to)? • Is this the route for your device -- pro’s and con’s? • Is this route being used too little...too much? 11

12. De Novo Classifications -- Examples • Diagnostic Assays • Antigen Invasive Fungal Pathogens • Sirolimus Assay • Test Factor V Leiden Mutaions, Genomic Dna Pcr Kit • Ninhydrin and L- Leucyl-L-Alanine (Fluorimetric), Phenylalanine Assay • Immunomagnetic, Circulating Cancer Cell Emuneration System • Elisa Antibody, West Nile Virus • Nitric Acid Breath Test 12

13. De Novo Classifications – Examples … • Endotoxin Activity Assay (June 16, 2003): Class II • Microbiology • Intended Use: Intended for use in conjunction with other laboratory findings and clinical assessment to aid in the risk assessment of critically ill patients for progression to severe sepsis on first day of admission to ICU. • Risks: No direct risks, failure to perform or error in interpretation may lead to improper patient management. • Special Controls: Endotoxin Assay Guidance; not 510(k) exempt 13

14. De Novo Classifications – Examples … • Heimlich Maneuver Assist Device (Sept. 30, 1999): Class II • Cardiovascular • Intended Use: to remove a foreign body airway obstruction through generation of expulsion pressure • Risks: incorrect use resulting in damage to internal organs; faulty design generating too much pressure resulting in patient injury • Special Controls: labeling with instructions for reporting complications; adequate instructions for lay users; design controls 14

15. De Novo Classifications – Examples … • Breast Lesion Documentation System (Jan. 31, 2003): Class II • Obstetrics Gynecology • Intended Use: producing surface map of the breast as an aid to document palpable breast lesions during clinical breast exam • Risks: failure to produce appropriate map; misinterpretation; improper use; skin irritation or toxicity; electric shock; electromagnetic interference; tissue trauma • Special Controls: labeling; materials safety information; performance characteristics; bench testing; software information 15

16. For more information ... • 21 U.S.C. §360c(f)(2)aka § 513(f)(2) of the FFDCA • FDA Guidance Document: • http://www.fda.gov/cdrh/modact/classiii.html • http://www.fda.gov/cdrh/modact/clasiii.pdf 16

17. Thanks To Carolyne Hathaway, Esq., of Latham & Watkins, for slides 12-15 -- examples of De Novo reclassifications -- taken from her September 2004 presentation on same subject. 17

18. Questions? Call, e-mail, fax or write: Michael A. Swit, Esq. Vice President, Life Sciences THE WEINBERG GROUP INC. 336 North Coast Hwy. 101 Suite C Encinitas, CA 92024 Phone 760.633.3343 Fax 760.633.3501 Cell 760.815.4762 D.C. Office 202.730.4123 michael.swit@weinberggroup.com www.weinberggroup.com 18

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