> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# ‘Troubling Pattern’ to CDRH Missed Deadlines: Attorneys
- URL: https://www.fdaweb.com/troubling-pattern-to-cdrh-missed-deadlines-attorneys/
- Published: 2020-02-26T12:00:00.000Z
- Updated: 2026-09-14T16:04:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146177

Attorneys **Jeffrey Gibbs** and **Véronique Li** (Hyman, Phelps & McNamara) say an increased tendency for CDRH to miss a variety of deadlines is a concern and starts to form “a troubling pattern.” Writing online in their firm’s *FDA Law Blog*, Gibbs and Li give examples of the types of deadlines being missed.

They write that in FY 2019 review time goals were missed for evaluating product recalls and Medical Device Reports. They also report that only 21 quality-related Warning Letters were issued to device manufacturers in the last year, marking the third consecutive year of a record low number of quality-related Warning Letters.

According to Gibbs and Li, FDA attributes the drop to the Center reorganization that eliminated the Office of Compliance, Office of Surveillance and Biometrics, and Office of Device Evaluation,

replacing them with the Office of Product Evaluation and Quality “super office.” FDA blamed the missed goals on the inexperience of staff with new responsibilities in the reorganization, they say.

But Gibbs and Li say the reorganization doesn’t explain other instances of FDA behaving outside the norm, such as flat-out declining a pre-submission meeting and not providing a revised version of meeting minutes within 30 days of acceptance. They also cite an instance in which a review team stayed consistent in discussions with the company and still missed its 510(k) MDUFA goal.

“We have noticed extended delays over posting decision summaries to the *de novo* database, which is supposed to be updated weekly,” Gibbs and Li add. “It has been nearly a year since several *de novos* were authorized with no decision summary posted. When pressed, FDA has not identified unusual circumstances contributing to these delays. Nor has it committed to posting the documents anytime soon…. While the reorganization might explain inconsistent reviews, it cannot explain all these failures to meet expectations.”