Determining the Regulatory Pathway to Market

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"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_at_FDA.HHS.GOV
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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

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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)

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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

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Safe Medical Devices Act (SMDA)

• 1990
• 513(i)
• Substantial Equivalence Defined
• 513(a)(1)(B)
• Special Controls

SMDA
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Food DrugModernization 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

FDAMA
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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)

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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

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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 . . . . . . . . . . . . .

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Substantially Equivalent (SE)

• 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.

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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

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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.

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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.

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510(k) Classification

• Approximately 80 are found SE
• 2 3 are found NSE
• Remaining 510(k)s are usually withdrawn

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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

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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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Thank You!