Under the Modernization of Cosmetics Regulation Act (MoCRA), cosmetics companies selling in the US now face a new requirement: serious adverse event reporting. This means companies must report any serious health problems associated with their products to the FDA within 15 business days.
What is a "Serious Adverse Event"?
A serious adverse event is defined as an event that results in:
Death
Life-threatening illness
Hospitalization
Persistent disability or incapacity
Congenital anomaly or birth defect
Significant disfigurement
Reporting Requirements
Responsible Persons (manufacturers, packers, or distributors) must submit detailed reports including:
Patient information
Event details
Suspect product information
Product label copy
Any new information about the event received within a year must also be reported.
Submitting Reports
Use the MedWatch Form 3500A to submit reports. This form requires detailed information and can be challenging for those new to adverse event reporting. You may need to submit additional supporting documents.
Other Adverse Event Requirements
Besides reporting, Responsible Persons must:
Receive and record all adverse events for at least 3 years (6 years for larger distributors).
Include contact information on product labels for consumers to report adverse events.
MoCRA's serious adverse event reporting requirement is a crucial aspect of compliance. By understanding and fulfilling these obligations, cosmetic companies can demonstrate their commitment to consumer safety and avoid potential regulatory issues.
While in-house or outsourced solutions can assist with adverse event data collection, they may fall short in providing the same level of expertise and efficiency as professional services or specialized software platforms.
Why Choose a Professional Solution?
Deep Regulatory Knowledge: Regulatory industry professionals possess in-depth knowledge of MoCRA and its specific requirements for serious adverse event reporting.
Up-to-Date Guidance: Software solutions developed by regulatory specialists incorporate the latest guidance and regulations, ensuring accurate and efficient data collection.
Optimized Data Collection: These solutions are designed to streamline data collection, reducing the risk of errors and facilitating easy report submission.
Efficiency and Accuracy: Built on extensive industry experience, these solutions work quickly and efficiently, minimizing human error.
Provision Consulting Group: Your MoCRA Compliance Partner
With over 10 years of experience as FDA regulatory experts, Provision Consulting Group has a proven track record of helping thousands of cosmetic companies navigate MoCRA regulations and bring safe products to market. We are committed to supporting our clients throughout the entire process, ensuring seamless compliance and minimizing risks.
Let us help you streamline your MoCRA compliance efforts and focus on what you do best: creating innovative and safe cosmetic products.
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