Postmarket Surveillance Studies Requirements for Medical Devices Under Section 522
This guidance outlines FDA's authority to require manufacturers to conduct postmarket surveillance for certain class II or class III devices, either at approval/clearance or afterward. It details the process, requirements, and responsibilities for implementing and reporting postmarket surveillance under section 522 of the FD&C Act.
What You Need to Know? 👇
What are the statutory criteria for FDA to issue a Section 522 postmarket surveillance order?
FDA can require postmarket surveillance for class II or III devices that: (1) could have serious adverse health consequences if they fail, (2) are expected to have significant pediatric use, (3) are implanted for more than one year, or (4) are life-sustaining/supporting devices used outside facilities.
How long does a manufacturer have to submit a postmarket surveillance plan after receiving a 522 order?
Manufacturers must submit a postmarket surveillance plan within 30 calendar days of receiving the 522 order. FDA aims to review and respond within 30 calendar days, with a maximum review time of 60 calendar days from plan receipt.
When is postmarket surveillance considered to have “commenced” under Section 522?
FDA typically considers postmarket surveillance to have commenced when the first subject is enrolled as outlined in the approved surveillance plan. For non-clinical studies without subject enrollment, surveillance commences when data accrual begins according to the approved plan.
What happens if a manufacturer fails to comply with Section 522 requirements?
Failure to comply with Section 522 requirements is a prohibited act under the FD&C Act and renders the device misbranded. This may result in enforcement actions including product seizure, injunction, prosecution, and/or civil money penalties.
Can manufacturers use real-world data sources to fulfill Section 522 surveillance requirements?
Yes, manufacturers may meet 522 order requirements through prospective or retrospective analysis of real-world data sources, such as device registries and electronic health records, when appropriate and scientifically valid for addressing the surveillance questions.
What information does FDA publicly disclose about Section 522 postmarket surveillance studies?
FDA posts study information on its 522 Postmarket Surveillance Studies Database, including manufacturer name, device details, study status, design parameters, enrollment progress, interim safety/effectiveness findings, and final results, while protecting trade secrets and patient privacy.
What You Need to Do 👇
Recommended Actions
- Develop and submit surveillance plan within 30 days of receiving 522 order
- Obtain FDA approval of plan before initiating surveillance
- Implement enrollment tracking system to meet recommended milestones
- Establish data collection and quality control procedures
- Set up regular reporting schedule (6-month intervals initially, then annual)
- Monitor study progress against approved timelines
- Communicate promptly with FDA regarding any delays or challenges
- Maintain complete documentation of all surveillance activities
- Submit final report within 3 months of study completion
- Ensure compliance with public disclosure requirements
Key Considerations
Clinical testing
- Must commence surveillance within 15 months of order issuance
- Recommended enrollment milestones:
- 20% enrolled within 18 months
- 50% enrolled within 21 months
- 100% enrolled within 24 months
- Must submit interim reports every 6 months for first 2 years, then annually
- Final report due within 3 months of study completion
- Must include subject accountability, safety/effectiveness data
- Must address diversity in sex, age, race and ethnicity when applicable
Non-clinical testing
- Data accrual milestone reports required to track progress
- Final report due within 3 months of last datapoint capture
Safety
- Must report adverse events and complications
- Must assess relatedness of endpoints with device/procedure
- Must provide post-mortem examination reports for deaths
Other considerations
- Must submit surveillance plan within 30 days of order receipt
- Plan must include objectives, methodology, sample size, data collection procedures
- Changes affecting data validity require FDA approval
- Failure to comply may result in enforcement actions
- Results may be publicly disclosed on FDA website
- Pediatric studies must comply with ClinicalTrials.gov requirements
Relevant Guidances 🔗
- Collection and Reporting of Race and Ethnicity Data in Clinical Trials
- Evaluation of Sex-Specific Data in Medical Device Clinical Studies
- Certifying Compliance with Clinical Trial Registration Requirements on Form FDA 3674
- Design Considerations for Medical Device Pivotal Clinical Studies
Related references and norms 📂
- 21 CFR Part 822: Postmarket Surveillance
- 21 CFR Part 10.75: Internal Agency Review of Decisions
- 21 CFR Part 16: Regulatory Hearing before the Food and Drug Administration