FDA ASCA Program for 510(k)

Report Revisions & Alternate Construction Evaluation

Have an existing compliance report that needs to be updated?  Report revisions can include changes to construction (alternate construction evaluation), software, documentation, or markings on the device or system. MECA will perform any required testing and implement report updates to reflect the necessary change(s).

Be prepared to provide the following when requesting this service:

  • Who issued the report (lab/agency)
  • Description of changes to the device (components, layout, construction, software, documentation, markings, etc.)
  • For component changes, the existing and new component specifications to determine what testing may be applicable
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