1. "Determining the Regulatory Pathway to Market" Classification Heather S. Rosecrans Director, 510(k) Staff Office of Device Evaluation Center for Devices & Radiological Health U.S. Food & Drug Administration (240) 276-4040 Heather.Rosecrans@FDA.HHS.GOV

2. 1 What is a 510(k)  Premarket Notification  Section 510(k) of FF,D,&C Act  21 CFR 807 Subpart E  Submission for Device Premarket Review  Allows FDA to Make a Determination Regarding Substantial Equivalence (SE)  “The” classification process for a device

3. 2 What a 510(k) Is Not  A Form  Establishment Registration (FDA-2891)  Device Listing (FDA-2892)  Premarket Approval (PMA)  Product Development Protocol (PDP)  Evaluation of Automatic Class III Designation (De Novo)

4. 3 Medical Device Amendments of 1976 to the FF,D,&C Act  May 28, 1976  Defined a device (201(h) of the Act)  Required risk based classification of device types legally on the market  Led to classification of approximately 1,700 different generic types of devices and grouped into 19 medical specialties  Required premarket review of devices

5. 4 Safe Medical Devices Act (SMDA)  1990 –513(i) Substantial Equivalence Defined –513(a)(1)(B) Special Controls

6. 5 Food & Drug Modernization Act (FDAMA)  1997 –Redefined 510(k) Exemption Criteria for Class I –Added Class II Exemption Criteria –De Novo –SE w/Limitations –Class II Petitions for Exemption

7. 6 510(k) & Classification  A 510(k) is the classification process for individual post-amendment devices by: –Finding the device substantially equivalent (SE) or –Finding the device not substantially equivalent (NSE)

8. 7 510(k) & Classification  Determination regarding substantial equivalence: –NSE (For reasons other than lack of performance data)  PMA, PDP, or De Novo –NSE for lack of performance data  a new 510(k) may be submitted for review –SE  To Market

9. 8 Substantially Equivalent (SE)  If: –In Comparison to a legally marketed device (that does not require PMA), it: Has the same intended use, and Has the same technological characteristics as the predicate device, Or.............

10. 9  Has the same intended use, and  Has different technological characteristics and the information in the 510(k): –Does not raise a new question(s) of safety and effectiveness; and –Demonstrates it is at least as safe and effective as the predicate. Substantially Equivalent (SE)

11. 10 510(k) & Classification  Finding the device not substantially equivalent (NSE): –automatically places device into class III and requires: PMA; Evaluation of Automatic Class III Designation (de novo); or Reclassification before marketing

12. 11 Not Substantially Equivalent (NSE)  There is no predicate device; or  The device has a new intended use; or  The device has different technological characteristics compared to the predicate device and raises a new type question(s) of safety and effectiveness *All of the above require no review of data and will require PMA or De Novo.

13. 12 Not Substantially Equivalent (NSE)  The data provided do not demonstrate that the device is at least as safe and effective as the predicate. *FDA usually asks for additional information at least once prior to determining the device is NSE for lack of data *The above NSE reason requires review of the data and would require submission of a new 510(k) with new data to demonstrate SE.

14. 13  Approximately 80% are found SE  2 – 3% are found NSE  Remaining 510(k)s are usually withdrawn 510(k) & Classification

15. Evaluation of Automatic Class III Designation “de novo” Classification  Section 513(f)(2)  De novo received within 30 days of receipt of NSE letter (NSE reason for other than lack of performance data)  No predicate/“Low risk” devices  60-day review period  Extensions for submission of additional information granted

16. Evaluation of Automatic Class III Designation “de novo” Classification (cont.)  If approved, new device proceeds immediately to market  30 days after the signed approval order, notification is published in FR  New classification regulation established  New device becomes new classification/predicate  Next person may submit a 510(k) and use de novo as the predicate

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