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FDA and Medical Device Reporting

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Tarek Elneil
Tarek Elneil

A failure of the device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. A malfunction should be considered reportable if any one of the following is true: 1. The chance of a death or serious injury 2.The malfunction affect the device in a catastrophic manner that may lead to a death or serious injury 3. The device fail to perform its essential function 4. The malfunction would be likely to cause or contribute to death or serious injury, regardless of how the device is used.

Health & Medicine
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MDR Reporting FDA Title 21 [§803.3(q)] Chapter 9 Subchapter V Part A- Drugs and Devices Sec. 360- Records and reports on devices
TAREK ELNEIL Quality Management Tools Principal Consultant telneil@msn.com Mobil: (805)732-1739
WHENAND WHATTO REPORT[§803.3(q)] • A report is required when a manufacturer becomes aware (see definition) of information that reasonably suggests that one of their marketed devices has or may have caused or contributed to a • death OR • serious injury OR • Device malfunctioned and that the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
WHENAND WHATTO REPORT[§803.3(q)] Serious injury/(Serious illness) [§803.3(aa)(1)] is an injury or illness that: • is life threatening, even if temporary in nature; • results in permanent impairment of a body function or permanent damage to a body structure; or • necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
WHENAND WHATTO REPORT[§803.3(q)] A malfunction [§803.3(m)] • is a failure of the device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. A malfunction should be considered reportable if any one of the following is true: • the chance of a death or serious injury occurring as a result of a recurrence of the malfunction is not remote; • the consequences of the malfunction affect the device in a catastrophic manner that may lead to a death or serious injury; • it causes the device to fail to perform its essential function and compromises the device’s therapeutic, monitoring or diagnostic effectiveness which could cause or contribute to a death or serious injury, or other significant adverse device experiences. The essential function of a device refers not only to the device’s labeled use, but for any use widely prescribed within the practice of medicine; • it involves an implant malfunction that would be likely to cause or contribute to death or serious injury, regardless of how the device is used; • the device is considered life-supporting or life-sustaining, and thus essential to maintaining human life; or
Risk to Health Evaluate Risk to Health Serious Injury Death
Serious Injury Definition Serious Injury Life Threatening Permanent impairment or damage to body function and structure Necessitates medical or surgical intervention to preclude permanent impairment or damage to body function or structure
Device Malfunction Medical Device Malfunction Device caused Death or Serious Injury Device likely to cause Death or Serious Injury Device contributed to Death or Serious Injury Functional
NO Yes MDR Decision Tree 1 Customer Complaint was received with the information suggest that the MD might be required Caused or contributed to Death File MDR Yes NO Caused life threatening Injury? File MDR 1 Start
MDR Decision Tree 2 Yes NO Resulted in permanent Impairment / damage to body function? File MDR 1 Yes NO Necessitate medical or surgical intervention to preclude permanent Impairment / damage to body function? File MDR 2 NO
NO MDR Decision Tree 3 2 Yes NO Necessitate medical or surgical intervention to preclude permanent Impairment / damage to body function? File MDR NO Was the device returned (3 attempts) ? YesInspect the device and review the DHR 3 4
Yes MDR Decision Tree 4 3 4 Was the returned device manufactured by us? Do not file MDR, close the investigation with justification NO NO NO Do not file MDR, close the investigation with justification Yes Was the returned device part of other competitor‘s system? Yes Is it possible to determine if our device was malfunction? 5 6
Yes NO MDR Decision Tree 5 5 6 NO Yes NO Yes File MDR Investigate (CAPA)for a new risk or a trend? Do not file MDR, close the investigation with justification Was the device malfunctioning caused or likely to cause or contributed to serious injury? Was the device malfunction?
Questions?

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FDA and Medical Device Reporting

  • 1. MDR Reporting FDA Title 21 [§803.3(q)] Chapter 9 Subchapter V Part A- Drugs and Devices Sec. 360- Records and reports on devices
  • 2. TAREK ELNEIL Quality Management Tools Principal Consultant telneil@msn.com Mobil: (805)732-1739
  • 3. WHENAND WHATTO REPORT[§803.3(q)] • A report is required when a manufacturer becomes aware (see definition) of information that reasonably suggests that one of their marketed devices has or may have caused or contributed to a • death OR • serious injury OR • Device malfunctioned and that the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
  • 4. WHENAND WHATTO REPORT[§803.3(q)] Serious injury/(Serious illness) [§803.3(aa)(1)] is an injury or illness that: • is life threatening, even if temporary in nature; • results in permanent impairment of a body function or permanent damage to a body structure; or • necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
  • 5. WHENAND WHATTO REPORT[§803.3(q)] A malfunction [§803.3(m)] • is a failure of the device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. A malfunction should be considered reportable if any one of the following is true: • the chance of a death or serious injury occurring as a result of a recurrence of the malfunction is not remote; • the consequences of the malfunction affect the device in a catastrophic manner that may lead to a death or serious injury; • it causes the device to fail to perform its essential function and compromises the device’s therapeutic, monitoring or diagnostic effectiveness which could cause or contribute to a death or serious injury, or other significant adverse device experiences. The essential function of a device refers not only to the device’s labeled use, but for any use widely prescribed within the practice of medicine; • it involves an implant malfunction that would be likely to cause or contribute to death or serious injury, regardless of how the device is used; • the device is considered life-supporting or life-sustaining, and thus essential to maintaining human life; or
  • 6. Risk to Health Evaluate Risk to Health Serious Injury Death
  • 7. Serious Injury Definition Serious Injury Life Threatening Permanent impairment or damage to body function and structure Necessitates medical or surgical intervention to preclude permanent impairment or damage to body function or structure
  • 8. Device Malfunction Medical Device Malfunction Device caused Death or Serious Injury Device likely to cause Death or Serious Injury Device contributed to Death or Serious Injury Functional
  • 9. NO Yes MDR Decision Tree 1 Customer Complaint was received with the information suggest that the MD might be required Caused or contributed to Death File MDR Yes NO Caused life threatening Injury? File MDR 1 Start
  • 10. MDR Decision Tree 2 Yes NO Resulted in permanent Impairment / damage to body function? File MDR 1 Yes NO Necessitate medical or surgical intervention to preclude permanent Impairment / damage to body function? File MDR 2 NO
  • 11. NO MDR Decision Tree 3 2 Yes NO Necessitate medical or surgical intervention to preclude permanent Impairment / damage to body function? File MDR NO Was the device returned (3 attempts) ? YesInspect the device and review the DHR 3 4
  • 12. Yes MDR Decision Tree 4 3 4 Was the returned device manufactured by us? Do not file MDR, close the investigation with justification NO NO NO Do not file MDR, close the investigation with justification Yes Was the returned device part of other competitor‘s system? Yes Is it possible to determine if our device was malfunction? 5 6
  • 13. Yes NO MDR Decision Tree 5 5 6 NO Yes NO Yes File MDR Investigate (CAPA)for a new risk or a trend? Do not file MDR, close the investigation with justification Was the device malfunctioning caused or likely to cause or contributed to serious injury? Was the device malfunction?