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# Need for Device Transparency Seen in Celect Case
- URL: https://www.fdaweb.com/need-for-device-transparency-seen-in-celect-case/
- Published: 2024-11-21T12:00:00.000Z
- Updated: 2026-09-14T14:47:43.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158242

Clinicians from several academic medical centers say litigation involving the Cook Celect inferior vena cava filter “demonstrates the need for greater transparency in medical device regulation,” especially involving 510(k) clearances. Writing in the *Annals of Internal Medicine*, the authors [say](https://www.acpjournals.org/doi/10.7326/ANNALS-24-00089?ref=fdaweb.com) (subscription or purchase required) regulatory reforms are necessary to ensure that critical safety data are accessible to clinicians and patients to allow for informed decision-making.

They assert that information about medical devices, including their testing and regulation, is often unavailable, creating patient safety risks. “Litigation can reveal data that are otherwise undisclosed to the public,” they say. By analyzing documents obtained during litigation over the Celect filter, the authors were able to compare what was known to the manufacturer and to FDA with what was publicly reported.

“The public record for Celect lacks information about FDA’s concerns, undisclosed studies and safety signals, deviations from standard research practices and FDA guidance, and inaccurate reporting of risks,” the article says. “This information asymmetry between what is known about a device during manufacturer development and FDA authorization and what information is publicly available precludes informed decision-making by patients and physicians. The Celect case highlights the need to improve transparency and integrity in medical device regulation.”

The authors say FDA missed opportunities for public reporting at multiple stages. They cite several FDA disclosure practices that they say work against transparency.

“Although some aspects of manufacturers’ interactions with FDA may be considered ‘confidential commercial information’ and may therefore be exempted from public reporting,” the authors write, “providing a full accounting of the regulatory history that is relevant to the public would improve the usefulness of disclosures.” They suggest that the agency build on a recent proposal that manufacturers provide details about predicate safety and prioritize adherence to voluntary consensus standards by disclosing details about previous review cycles and requiring 510(k) summaries to be prepared by independent agency employees.

“Advancing transparency requires an active approach,” the article says. “For example, FDA can request source data from manufacturers for verification, yet it is unknown how often this authority is exercised. Furthermore, FDA has authorized postmarket surveillance under Section 522 for fewer than 1% of devices authorized under 510(k) like Celect. Even when mandated, studies are often significantly delayed.”