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UPCOMING CHANGES TO FDA ELECTRONIC MEDICAL DEVICE REPORTING (EMDR) IN 2018
Medical device manufacturers and importers are required to report “adverse events” to FDA when their device has caused or contributed to death or serious injury. An “adverse event” is when a device has a malfunction that could cause death or serious injury. Importers report this information to the manufacturer. The U.S. Food and Drug Administration (FDA) has announced that it will update certain codes used for Adverse Event Reporting through the Electronic Medical Device Reporting (eMDR) system on April 6, 2018.
The Agency will replace the codes for FDA Device Problem, Manufacturer Evaluation Method, Manufacturer Evaluation Result, and Manufacturer Evaluation Conclusion with similar codes established by the International Medical Device Regulators Forum (IMDRF).
IMDRF has released public references to help map FDA codes to the new codes during the interim before the update. For example, the current FDA Device Problem Code 2682 refers to an “issue associated with the interaction between the patient’s physiology or anatomy and the device that affects patient and/or device.” This code corresponds to and will be replaced by IMDRF code A0101, a “problem associated with the interaction between the patient’s physiology or anatomy and the device that affects the patient and/or the device.”
Despite this mapping, reporting parties will not be able to rely on FDA codes after the update. Some IMDRF codes do not have a current FDA equivalent, and FDA has further stated that the submission of retired FDA codes following the update will be rejected by the eMDR system. As such, reporting parties should familiarize themselves with the IMDRF codes for a smooth transition into these changes.
If you are a reporting party in need of assistance, Registrar Corp can guide you through the eSubmitter software and facilitate your Adverse Event Report submission to eMDR. Registrar Corp offers Adverse Event Reporting assistance at no fee to clients of our U.S. Agent Service. Call us at +1-757-224-0177.
FDA RELEASES FY 2017 INSPECTIONAL OBSERVATIONS; REGISTRAR CORP REPORTS ON COMMON FOOD SAFETY VIOLATIONS
The U.S. Food and Drug Administration (FDA) recently released its inspectional observation data for fiscal year (FY) 2017. The data presents an overview of violations cited by FDA during routine food facility inspections from October 2016 through September 2017. FDA consulting firm Registrar Corp compiled the most commonly cited food safety violations:
Lack of Effective Pest Exclusion/Screening – The facility does not take effective measures to protect food against contamination from pests or exclude pests from food production areas.
Sanitation Monitoring – The facility does not monitor sanitation conditions and practices frequently enough to conform to current good manufacturing practices (CGMPs). Some factors that should be monitored include the safety of water coming into contact with food and food contact surfaces, the condition and cleanliness of food contact surfaces, and the measures used to prevent cross-contamination from unsanitary objects.
Plant Cleanliness – The facility fails to maintain cleanliness of the premises, or the facility is not constructed in a way that allows for proper sanitation or maintenance of floors, walls, and ceilings.
HACCP Plan Implementation – A facility manufacturing seafood or juice fails to implement procedures in its HACCP plan. These may include monitoring critical control points of food hazards, verifying the adequacy of the plan’s hazard control, or maintaining records as required by 21 CFR Part 123
Reasonable Precautions – The facility does not take precautions to prevent production procedures from contaminating food. Reasonable precautions may include monitoring food processing time and temperature or monitoring manufacturing operations, such as freezing or heat processing.
The violations listed above are nearly identical to the most common violations cited in FY 2016 and FY 2015. Food facilities should use this pattern to anticipate what areas in their daily operations may require further review before a FDA inspection.
It is worth mentioning that the 2017 list is the first to include violations related to FDA’s Preventive Controls Rules and Foreign Supplier Verification Program (FSVP) Rule, both of which had compliance deadlines in 2017. Most food facilities are now required to have implemented HARPC food safety plans, and many importers are required to have FSVPs. Despite the first FSVP compliance deadline passing as recently as May 2017, failure to develop an FSVP was cited 108 times. With the next FSVP deadline landing in March 2018, it is probable that FSMA violations may make their way to the top next year.
Inspection violations can result in Warning Letters, placement on Import Alert, suspension of facility registration, and other enforcement actions. With proper preparation and guidance, these food safety issues can be corrected before FDA visits a facility. Registrar Corp’s Food Safety Specialists can conduct a mock FDA inspection of your facility to identify potential food safety violations. Our expert, onsite assistance can guide your facility with knowledge and tools to have a successful FDA inspection.
Medical device manufacturers and importers are required to report “adverse events” to FDA when their device has caused or contributed to death or serious injury. An “adverse event” is when a device has a malfunction that could cause death or serious injury. Importers report this information to the manufacturer. The U.S. Food and Drug Administration (FDA) has announced that it will update certain codes used for Adverse Event Reporting through the Electronic Medical Device Reporting (eMDR) system on April 6, 2018.
The Agency will replace the codes for FDA Device Problem, Manufacturer Evaluation Method, Manufacturer Evaluation Result, and Manufacturer Evaluation Conclusion with similar codes established by the International Medical Device Regulators Forum (IMDRF).
IMDRF has released public references to help map FDA codes to the new codes during the interim before the update. For example, the current FDA Device Problem Code 2682 refers to an “issue associated with the interaction between the patient’s physiology or anatomy and the device that affects patient and/or device.” This code corresponds to and will be replaced by IMDRF code A0101, a “problem associated with the interaction between the patient’s physiology or anatomy and the device that affects the patient and/or the device.”
Despite this mapping, reporting parties will not be able to rely on FDA codes after the update. Some IMDRF codes do not have a current FDA equivalent, and FDA has further stated that the submission of retired FDA codes following the update will be rejected by the eMDR system. As such, reporting parties should familiarize themselves with the IMDRF codes for a smooth transition into these changes.
If you are a reporting party in need of assistance, Registrar Corp can guide you through the eSubmitter software and facilitate your Adverse Event Report submission to eMDR. Registrar Corp offers Adverse Event Reporting assistance at no fee to clients of our U.S. Agent Service. Call us at +1-757-224-0177.
FDA RELEASES FY 2017 INSPECTIONAL OBSERVATIONS; REGISTRAR CORP REPORTS ON COMMON FOOD SAFETY VIOLATIONS
The U.S. Food and Drug Administration (FDA) recently released its inspectional observation data for fiscal year (FY) 2017. The data presents an overview of violations cited by FDA during routine food facility inspections from October 2016 through September 2017. FDA consulting firm Registrar Corp compiled the most commonly cited food safety violations:
Lack of Effective Pest Exclusion/Screening – The facility does not take effective measures to protect food against contamination from pests or exclude pests from food production areas.
Sanitation Monitoring – The facility does not monitor sanitation conditions and practices frequently enough to conform to current good manufacturing practices (CGMPs). Some factors that should be monitored include the safety of water coming into contact with food and food contact surfaces, the condition and cleanliness of food contact surfaces, and the measures used to prevent cross-contamination from unsanitary objects.
Plant Cleanliness – The facility fails to maintain cleanliness of the premises, or the facility is not constructed in a way that allows for proper sanitation or maintenance of floors, walls, and ceilings.
HACCP Plan Implementation – A facility manufacturing seafood or juice fails to implement procedures in its HACCP plan. These may include monitoring critical control points of food hazards, verifying the adequacy of the plan’s hazard control, or maintaining records as required by 21 CFR Part 123
Reasonable Precautions – The facility does not take precautions to prevent production procedures from contaminating food. Reasonable precautions may include monitoring food processing time and temperature or monitoring manufacturing operations, such as freezing or heat processing.
The violations listed above are nearly identical to the most common violations cited in FY 2016 and FY 2015. Food facilities should use this pattern to anticipate what areas in their daily operations may require further review before a FDA inspection.
It is worth mentioning that the 2017 list is the first to include violations related to FDA’s Preventive Controls Rules and Foreign Supplier Verification Program (FSVP) Rule, both of which had compliance deadlines in 2017. Most food facilities are now required to have implemented HARPC food safety plans, and many importers are required to have FSVPs. Despite the first FSVP compliance deadline passing as recently as May 2017, failure to develop an FSVP was cited 108 times. With the next FSVP deadline landing in March 2018, it is probable that FSMA violations may make their way to the top next year.
Inspection violations can result in Warning Letters, placement on Import Alert, suspension of facility registration, and other enforcement actions. With proper preparation and guidance, these food safety issues can be corrected before FDA visits a facility. Registrar Corp’s Food Safety Specialists can conduct a mock FDA inspection of your facility to identify potential food safety violations. Our expert, onsite assistance can guide your facility with knowledge and tools to have a successful FDA inspection.
