Clinical Research
FDA clearance or approval is not the end of regulatory obligations — it is the beginning of an ongoing commitment to monitor device performance in real-world use. Post-market surveillance programs that don't function correctly generate MDR reporting failures, warning letters, and recall risk.
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Under 21 CFR Part 822, FDA may order manufacturers of Class II or Class III devices to conduct post-market surveillance when the failure of the device would be reasonably likely to cause serious adverse health consequences, the device is intended to be implanted for more than one year, or the device is intended to be a life-sustaining or life-supporting device used outside of a user facility. Post-market surveillance under a 522 order requires an approved surveillance plan and periodic reporting to FDA — typically via annual progress reports.
Even where 21 CFR Part 822 surveillance is not ordered, all device manufacturers operating under FDA clearance or approval have complaint handling and MDR reporting obligations. Under 21 CFR 820.198 and 21 CFR Part 803, manufacturers must maintain procedures for receiving, reviewing, and evaluating complaints — and must report device malfunctions, serious injuries, and deaths to FDA within specified timeframes. Thirty-day reports and five-day reports have different triggers and different content requirements, and the failure to file required MDRs is among the most common 483 observations in FDA device inspections.
Complaint handling is not a reactive activity — it is a structured process with documented decision points that determine regulatory reporting obligations. Every complaint received must be evaluated to determine whether it constitutes a reportable MDR. That determination requires documented reasoning: what event occurred, what device was involved, did a malfunction occur, was there an injury, and would the malfunction be likely to cause or contribute to serious injury if it recurred. The documentation of this analysis is what FDA inspectors review when assessing complaint handling compliance.
The most common complaint handling deficiencies are: complaints received through customer service channels that are never entered into the quality system, malfunction events evaluated against the wrong reporting threshold, and MDR decisions documented without sufficient analysis of the event. We build complaint handling systems with decision trees, documentation templates, and escalation protocols that produce defensible MDR determinations consistently.
For companies operating in the EU under the Medical Device Regulation (EU MDR 2017/745), Post-Market Clinical Follow-Up (PMCF) is a mandatory component of post-market surveillance for Class IIa, IIb, and III devices. PMCF may include systematic literature reviews, device registry participation, or prospective clinical investigations. The PMCF plan is reviewed during notified body audits, and inadequate PMCF plans are a common finding in EU MDR technical documentation reviews. We design PMCF plans that satisfy EU MDR Annex XIV requirements and MDCG guidance, and we support PMCF study design and execution for companies maintaining CE marks under the new regulation.
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Post-market surveillance is how FDA knows your device continues to perform safely after clearance. We build PMS programs designed to detect problems early and satisfy FDA inspection requirements at every stage of commercial life.