News and analysis on medical technology

Delayed-Studies Report Shows How FDA-Ordered Postmarket Studies Work

FDA can require more research after a drug or device reaches the market, through post-approval studies, Section 522 orders and drug postmarketing requirements, and it tracks their status in public databases.

By News DeskSeptember 18, 20263 min read
A mechanical testing machine in an FDA laboratory.
Equipment in an FDA mechanical testing laboratory, where the agency studies how device materials respond to stress, 2011. Not a device named in this article. U.S. Food and Drug Administration, Public domain, via Wikimedia Commons · Public domain (US government work; FDA Flickr, flickr.com/photos/fdaphotos/5426178594)

Key points

  • A KFF Health News analysis published Sept. 18 found nearly 600 FDA-mandated or promised postmarket studies listed as delayed for drugs and biologics, involving almost 350 products, with dozens more device studies behind schedule.
  • For devices, FDA can make post-approval studies a condition of a PMA or HDE approval, and can order Section 522 postmarket surveillance for certain Class II and Class III devices.
  • For drugs, FDA separates postmarketing requirements, which a law or regulation compels, from postmarketing commitments, which a sponsor agrees to but is not required to conduct.

Hundreds of studies that FDA required or that manufacturers promised to run after their products reached the market are listed as behind schedule, KFF Health News reported on Sept. 18. Its analysis of an FDA database downloaded in August found nearly 600 delayed studies for drugs and biologics, involving almost 350 products, and said other FDA databases listed dozens of medical device studies as behind schedule.

The report quoted a Department of Health and Human Services spokesperson, Emily Hilliard, as saying that "Assessing the significance of any delay requires a case-specific review," and that a delay "should not be treated as evidence that a product has an unresolved safety or effectiveness issue." KFF said FDA defines delayed as behind the original schedule, which can mean off track or overdue.

The studies in question fall under several distinct FDA authorities, each with its own rules and public database.

Two routes for devices

The first is the post-approval study. According to FDA's Post-Approval Studies Program page, the agency may require one or more studies at the time it approves a premarket approval application (PMA), the pathway for high-risk devices, or a Humanitarian Device Exemption (HDE). FDA describes these studies as "conditions of device approval" and says a sponsor's failure to comply with any post-approval requirement "may be grounds for the FDA to withdraw approval."

The second is a Section 522 order, named for the part of the Federal Food, Drug, and Cosmetic Act that authorizes it. FDA's 522 program page says the agency can require a manufacturer to conduct postmarket surveillance of a Class II or Class III device that meets any of four criteria: its failure would be reasonably likely to have serious adverse health consequences; it is expected to have significant use in pediatric populations; it is intended to be implanted for more than one year; or it is intended to be life-sustaining or life-supporting and used outside a device user facility. Unlike a post-approval study, a 522 order can reach devices that came to market through 510(k) clearance, since many of those are Class II.

FDA runs a public database for each program. The agency says the databases show a study's description, interim and final results, an overall study status and the company's reporting status for each submission due, and that both are updated every Sunday. The protocols themselves, and the 522 orders, can be requested under the Freedom of Information Act, FDA says.

Requirements and commitments for drugs

For drugs and biologics, FDA uses two terms. Its postmarketing requirements and commitments page defines postmarketing requirements (PMRs) as studies and clinical trials that sponsors are required to conduct under one or more statutes or regulations, and postmarketing commitments (PMCs) as studies a sponsor has agreed to conduct that are not required by statute or regulation.

FDA says the 2007 Food and Drug Administration Amendments Act gave it specific authority to require postmarket safety studies and clinical trials to assess possible serious risks. Before that law, the agency could already require studies in narrower situations, including trials to show clinical benefit for drugs granted accelerated approval and deferred pediatric studies under the Pediatric Research Equity Act.

What the delays involve

The KFF report gave examples from both sides. For devices, it cited a pediatric study of the CustomFlex Artificial Iris whose protocol was accepted in 2019 and which, according to an FDA page downloaded in August, had enrolled zero patients; a representative for the study told KFF the rarity of the eye condition aniridia makes enrollment difficult. It also cited a study of the Scandinavian Total Ankle Replacement system that was meant to include at least 500 subjects and enrolled 142, according to the database.

FDA has enforcement powers and uses them "where appropriate," KFF quoted Hilliard as saying. The report said companies can continue to sell products while postmarket studies are ongoing, and that in some cases FDA has granted extensions while in others it has denied them.

Sources

  1. The Drugs and Devices Have Been on the Market for Years. But FDA-Ordered Studies Still Aren't Done., KFF Health News, September 18, 2026
  2. Post-Approval Studies Program, U.S. Food and Drug Administration
  3. 522 Postmarket Surveillance Studies Program, U.S. Food and Drug Administration
  4. Postmarketing Requirements and Commitments: Introduction, U.S. Food and Drug Administration