The new Office of Product Evaluation and Quality (OPEQ) at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) officially launched on Wednesday, CDRH Director Jeffrey Shuren announced at the 2019 FDA/Xavier MedCon conference in Cincinnati.
OPEQ—deemed by CDRH as the “super office”—internally puts into practice the total product lifecycle approach (TPLC) to regulatory decision-making in premarket reviews, postmarket surveillance and enforcement by using a team-based approach. Its launch results in seven new product-specific offices.
CDRH has been applying a TPLC approach in its decision making for many years but it had not been well structured to support that approach, said Shuren. Reviews, surveillance, compliance and quality have been siloed in separate offices, making it difficult to share information and leverage expertise. OPEQ makes this easier and it provides assurance that handoffs occur in an efficient manner, Shuren added.
A 2018 pilot confirmed OPEQ’s concept under CDRH’s reorganization, which is being
phased-in as of March.
CDRH’s reorganization plan recognized that a single customer or firm must sometimes deal with multiple offices. Each office under OPEQ now serves as a one-stop shop that caters to all needs.
“No more running to different offices, no more running to different people” thanks to OPEQ, said Shuren.
CDRH’s management structure and points of contacts in the management directory. Yet Marjorie Shulman, director of CDRH’s 510(k) program, told Focus
the organizational change that OPEQ brings will not be apparent from the outside nor will the change dramatically affect existing workflows.
The CDRH reorganization also established two additional offices. These are the Office of Policy (OP) and the Office of Strategic Partnerships and Technology (OST).
From the pilot programs on case for quality and FDA recognized standards to cybersecurity and the National Evaluation System for health Technology (NEST), Shuren covered a wide range of additional updates from CDRH. Like 2018
, 2019 is set to be an action-packed year as many initiatives are solidified.
The 2018 Case for Quality Voluntary Improvement Program
will be implemented in 2019 as an official program that will mirror NEST as part of the agency’s medical device safety action plan
. CDRH will also issue draft guidance on the new Safer Technologies Program
and a peer-reviewed white paper on hypersensitivity to metal implants under the plan. The latter is in line with plans on device materials
This year’s cybersecurity actions include finalizing the October 2018 draft guidance
that proposed major updates to 2014 premarket policies, submitting the common vulnerability scoring system
(CVSS) clinical rubric for qualification as a medical device development tool, operationalizing the software bill of materials, as well as completing the International Medical Device Regulators Forum (IMDRF) new work item
for harmonized cybersecurity principles and proof of concept on a CyberMed Safety Analysis Board.
Shuren noted launches in 2019 include NEST
version 2.0 and the Accreditation Scheme for Conformity Assessment
. CDRH will use 2019 appropriations to turn its digital health program into a new Center of Excellence
and submit the medical device single review program draft document, which will use some requirements from ISO/IEC standards, to IMDRF’s management committee for public consultation in June.