Corrections and Removals

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					        Warning Letters
Changes that Require a New 510(k)

  MedCon Medical Device Conference
         Regulatory Track
           May 4, 2011
         Identifying the Changes
   FDA inspection

   Identification of a change that may require a
    new 510(k)

   Verification by CDRH

   Issuance of Warning Letter
Review of these systems by the FDA
Investigator can reveal changes that
        require a new 510(k):

   Design Controls
   Corrective and Preventive Actions
   Material Controls
   Sterilization Process Controls
    Corrections and Removals
Changes Requiring a New 510(k)
         Guidance Document

“Deciding When to Submit a 510(k) for
   a Change to an Existing Device”
 Document issued on January 10, 1997
           CAPA or Design reveal
             Labeling Changes

   Affects the indications for use
   Add a contraindication
   Delete contraindication

For Example:
Does a CAPA result in adding a contraindication?
     CAPA or Design reveal
Technology or Performance Change
   Control Mechanism

   Operating Principle

   Energy Type
Technology or Performance Change
   Environmental Specification which affect indication for
   Performance Specification which affect indication for
   Ergonomics of patient-user interface which affect
    indication for use
   Dimensional Specifications which affect indication for
   Software or firmware changes which affect indication
    for use
Technology or Performance Change
   For any changes listed on the previous slide is
    clinical data necessary to establish S&E for
    purposes of substantial equivalence

    For any changes listed on the previous slide do
    results of design validation raise new issues of
    S&E (Risk Analysis)

Incremental changes over time may
 collectively be significant and require a new
 510(k) submission
 Pre- Amendment devices
Technology or Performance Change

   Review of the sterilization process reveals a
    sterilization method change that causes a change
    in properties/specifications of the device, or
    decrease the SAL to less than 10-6.
          Supplier Controls reveal
             Material Change

   Material type
   Material formulation
   Material supplier
             Material Changes
   Review of CAPA can identify changes that are
    made to material formulations and the type of
    materials to correct a product problem.

    Review of Design Controls can identify
    changes that are made to material formulations
    and the type of materials to improve the product
             Material Changes
   Review of Supplier Controls may reveal that the
    supplier was no longer available and the new
    supplier had to change the formulation or the
    material type.
          Correction or Removal

   The correction or removal taken causes a change
    in labeling, technology, performance, or
    materials that would require a new 510(k).
              510(k) CHANGES
   The decision that a new 510(k) is NOT needed must be

   The District contacts CDRH Office of Compliance and
    request a review of the change(s) to determine if the
    change(s) require a new 510(k).

   Several Warning Letters have been issued for not
    submitting a new 510(k) for changes.
Contact Information
       Gina Brackett
    Compliance Officer
     Cincinnati District