FDA’s Device Inspections Program Sets FY19 Performance Goals

Regulatory NewsRegulatory News
| 02 May 2019 | By Ana Mulero 

New performance goals for the Office of Medical Device and Radiological Health Operations (OMDRHO) at the US Food and Drug Administration (FDA) were set on FDA’s and industry’s follow-up to inspections.

The performance goals for fiscal year (FY) 2019 are intended to tell the story behind inspection metrics in terms of the public health impact, OMDRHO Director Jan Welch said at the 2019 FDA/Xavier MedCon conference in Cincinnati. Welch, who took the helm at OMDRHO with the 2017 restructuring of FDA’s Office of Regulatory Affairs (ORA), said the story could help identify what patients were protected by the increased enforcement and surveillance efforts.

“It’s hard for us” to track the effect of an inspection because “we don’t really always know how many devices there are in distribution at any point in time,” said Welch.

This year, OMDRHO has two performance measures in ORA to report performance differently in its Congressional budget justification. The first measure relates to the percentage of firms with significant inspection violations that received appropriate follow-up from OMDRHO, while the second applies to the percentage of firms that moved toward compliance following significant inspection violations.

The first FY2019 goal is to complete 80% of appropriate follow-up action for noncompliant medical device manufacturers. This could be in the form of a follow-up FDA site visit or a meeting with a firm to aid in tracking and confirming any additional corrective actions implemented after an inspection, noted Welch.   

OMDRHO’s second performance goal builds on the aim of the first performance goal. To this end, Welch said this goal completes the larger picture of all follow-up on OMDRHO’s inspections. It is intended to facilitate moving 65% of firms in Official Action Indicated (OAI) status—meaning firms out of compliance with recommended administrative or regulatory actions—in the direction of non-OAI status.

OMDRHO already sits at about 80% in appropriate follow-ups and devices are already in “pretty good shape” on the moving toward compliance front, said Welch. The goals come from ORA and may be too low but offer a better approach to measure performance than solely relying on work plans, she added.

ORA’s device program may eventually also set performance goals for recalls, according to Welch. FDA’s Center for Devices and Radiological Health (CDRH), which partners with ORA on developing work plans and priorities for operations such as inspections and compliance, reported last November recent increases in percentages of voluntary recalls and inspections conducted both domestically and overseas.


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