CDRH Outlines Sweeping Overhaul of Inspections/Enforcement Programs
The FDA unveiled a broad plan that will change the way it inspects devicemakers, handles recalls, issues and reviews enforcement decisions and screens imports, with companies likely to start feeling the impact by the end of 2015.
The reorganization will create a distinct inspectorate for just medical devices, eliminating the existing region-based model.
In an eight-page document, CDRH outlined the steps it will take over the next 12 months to create a new specialized approach to inspections. The plan includes creating specialist investigators who will be extensively trained in specific types of devices.
CDRH says it will survey staff to subdivide its inspectorate into subspecialties. It has already identified one area that it intends to carve out as a subspecialty — radiological and mammography inspections.
The overhaul is designed to revise CDRH’s compliance program from one that is enforcement-heavy to one that will work with manufacturers proactively to prevent compliance problems.
CDRH will work to create more metric-driven inspections, at this point planning to reach out to industry to identify specific product attributes that can be measured and used as quality indicators.
The center also will conduct a lengthy review of all compliance and policy guides and come up with a schedule for updating them. That effort is expected to take five years to complete.
Also, the agency will streamline its approach to approving and issuing 483s and warning letters to make faster decisions with respect to enforcement actions, though details of this part of the reorganization remain sketchy.
By fall 2015, CDRH and ORA will speed up the way the agency screens imports by creating a risk-based imports entry review program that will allow it to quickly identify adulterated products.
MDSAP Will Be Supported
The changes coming to CDRH’s recall process are also not fully fleshed out, but the agency says it will review its recall procedures to look for areas to improve efficiency. The center says it will also evaluate its current laboratory structure to look for efficiencies.
As CDRH refines its inspections approach, devicemakers will still be able to opt to participate in the Medical Device Single Audit Program, which was developed by the International Medical Device Regulators Forum and recently launched as a pilot. The center will also look at ways to breathe new life into its third-party auditor program.
Steve Niedelman, lead quality systems and compliance consultant at King & Spaulding, says he is encouraged by the proactive approach.
Devicemakers should see a payoff from the increased training and specialization of investigators, Niedelman said. “All too often you hear from industry that the inspector didn’t know about the product or what it does. This hopefully will dispel some of those concerns and improve the quality of the relationship during the inspection, as well as the knowledge of the investigator,” he says.
One possible downside of the overhaul: Depending on how ORA realigns, devicemakers could face an investigator who is coming from far away, Niedelman says. “Firms like to have good working relationships with their districts, and that might be affected.”
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