Post-Marketing Surveillance: The Obligation That Outlasts the Acquisition

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FDA clearance or approval is not the end of a device's regulatory obligations; it starts a different set. Post-approval study requirements, postmarket surveillance orders, medical device reporting and reporting of corrections and removals continue for as long as the device is marketed. For acquirers, these obligations stay with the product and can surface as unbudgeted operating cost after close.

They attach to the product's manufacturer or approval holder, so after close they are the acquirer's to meet. Contract terms with the seller can shift the cost of past failures, but not the obligation itself.

Categories of Postmarket Obligations

• Post-approval studies: when approving a PMA, humanitarian device exemption or product development protocol, FDA can require a post-approval study; for PMAs, the approval order can require continuing evaluation and periodic reporting on the device's safety, effectiveness and reliability (21 CFR 814.82).
• Section 522 postmarket surveillance: FDA can order surveillance of certain Class II and Class III devices, such as those whose failure would be reasonably likely to have serious adverse health consequences, implants intended to remain in the body more than a year, or devices expected to have significant pediatric use, generally for up to 36 months.
• Medical device reporting: manufacturers must report deaths, serious injuries and certain malfunctions to FDA, generally within 30 calendar days of becoming aware of them (21 CFR 803.50).
• Corrections and removals: manufacturers must report corrections or removals initiated to reduce a risk to health, or to remedy a violation that may present a risk to health, within 10 working days of starting them (21 CFR 806.10).
• Real-world evidence: where real-world data support a regulatory decision or labeling, the registries and data sources behind them need to be maintained; FDA's final guidance on using real-world evidence for medical devices was announced December 18, 2025.

Post-Approval Study Status

FDA's Post-Approval Studies database shows each study's status, and some studies run behind their original schedules. The stakes for a PMA device are concrete: FDA may withdraw approval of a PMA if a postapproval requirement imposed by the approval order or by regulation has not been met (21 CFR 814.46). An acquirer can inherit a study that is behind schedule and missing from the budget.

Section 522 Orders

Because a 522 order can come after a device has been on the market for years, when a safety question emerges, an acquirer can face a new study obligation on a product it bought as mature. The cost falls on the current manufacturer, whenever the device was cleared or approved. FDA's 522 Postmarket Surveillance Studies database lists orders and their status.

Real-World Evidence Commitments

Real-world evidence can support new indications, labeling changes and continued evaluation, but it depends on infrastructure: registry participation, data agreements and analysis capability. An acquirer without that capability may need to build or buy it; the same evidence can also matter for coverage, as our article on payer evidence describes.

Diligence Approach

Search FDA's Post-Approval Studies and 522 databases for the target's products and compare each study's status with its schedule. Review adverse event reports in FDA's MAUDE database, keeping in mind that MAUDE is a passive reporting system whose report counts reflect reporting behavior and installed base as well as device performance. Request FDA correspondence on any 522 orders, post-approval study discussions and recalls, and review complaint files and open corrective and preventive actions tied to surveillance signals. Then build the projected cost of these obligations into the deal model as an operating expense, not a contingency.

Postmarket obligations are predictable, persistent and inherited with the product. Treating them as edge cases understates first-year operating costs; diligence can size them and price them into the deal.