MoCRA Serious Adverse Event Reporting Service
Adverse event intake, serious event reports to FDA and record keeping, as MoCRA requires of the responsible person.
- Signed by a qualified safety assessor
- Regulator-ready, or we revise it free
- Delivered in 24, 48 or 72 hours
Trusted by brands including
Service details
Everything included, explained
Quick answer
Under MoCRA, the responsible person must report serious adverse events from US cosmetic use to FDA within 15 business days and keep records for 6 years. Our managed annual plan covers intake, triage and record keeping, from £2,250 a year for 1–10 products. Each serious event report on MedWatch Form 3500A is £450.
What's included in your adverse event service
| Document | What it is |
|---|---|
| Intake | Reports received at our US contact and logged |
| Triage | Each report assessed against the MoCRA definition of a serious adverse event |
| FDA report | Serious events reported on MedWatch Form 3500A within 15 business days (per-event fee) |
| Follow-up | New medical information received within a year sent to FDA |
| Records | Adverse event records kept for 6 years |
Who this service is for
- Brands whose responsible person needs an adverse event process
- Brands using our US Responsible Person service
- US brands without in-house regulatory staff
What this service does not include
- Medical advice or treatment. We do not advise consumers medically.
- Product recalls. Handled separately with you.
- Legal defence of claims.
- Serious event reports on the annual plan alone. Each FDA report is charged per event.
How it works
- Set up We agree the intake contact and the information you must send us.
- Intake Reports are logged and triaged.
- Report If an event is serious, we prepare and file the MedWatch report within 15 business days.
- Records All reports are kept for 6 years.
What is MoCRA adverse event reporting?
MoCRA added section 605 to the FD&C Act. The responsible person for a cosmetic must report any serious adverse event associated with its use in the US to FDA within 15 business days of receiving the report, usually on MedWatch Form 3500A, and send any new medical information received within one year. Adverse event records must be kept for 6 years, or 3 years for small businesses. Small businesses are not exempt from this duty.
What counts as a serious adverse event
Serious outcomes include:
- Death or a life-threatening experience.
- Inpatient hospitalisation.
- Persistent or significant disability or incapacity.
- A congenital anomaly or birth defect.
- Infection, or significant disfigurement such as serious rashes or burns.
- Medical or surgical intervention needed to prevent one of these outcomes.
What you receive
- An agreed intake process and contact
- A log of every report received
- Filed MedWatch reports for serious events
- 6-year record keeping
Legal framework
- FD&C Act section 605(a) — definition of serious adverse event
- Section 605(b) — report to FDA within 15 business days; new information within 1 year
- Section 605(e) — records kept for 6 years (3 for small businesses)
- Section 612 — the small business exemption does not cover adverse event reporting
Official sources:
- Modernization of Cosmetics Regulation Act of 2022 (FDA)
- Registration and Listing of Cosmetic Product Facilities and Products (FDA)
Why brands choose Phoenix
- Intake at Phoenix Safety Consultants LLC — a real US contact.
- Clear triage — serious or not, recorded either way.
- Fits with our responsible person service.
- Reviewed by Syed Muhammad Shamuel Shees, US Regulatory Lead.
Have a process before the first report arrives. Order above, or message us on WhatsApp on +44 7346 009332.
Frequently asked questions
How quickly must a serious adverse event be reported to FDA?
Within 15 business days of the responsible person receiving the report, under FD&C Act section 605.
What is a serious adverse event?
One that results in death, a life-threatening experience, hospitalisation, lasting disability, a birth defect, infection or significant disfigurement, or that needs medical intervention to prevent these.
Are small businesses exempt from adverse event reporting?
No. The MoCRA small business exemption does not cover adverse event reporting.
How long must adverse event records be kept?
6 years, or 3 years for small businesses.
What does the annual plan cover?
Intake, triage and record keeping for 12 months. Each serious event report filed with FDA is charged separately.
How much does the service cost?
Annual plans are £2,250 for 1–10 products, £2,950 for 11–25, £3,950 for 26–50 and £4,950 for 51–100. Each serious event report to FDA is £450.