Dive Brief:
- FDA Wednesday said it has launched a major component of its reorganization of the Center for Devices and Radiological Health, intended to combine oversight of premarket and postmarket device review.
- The initiation of the new Office of Product Evaluation and Quality will enable FDA to have greater insight into the total product lifecycle of medical devices, according to its director, William Maisel.
- The agency started the reorganization effort to create a "super office" in March, aiming to break down silos within the center to streamline processes. FDA said it plans to complete the reorganization of its four device offices into OPEQ by the end of September.
Dive Insight:
CDRH Director Jeff Shuren said in a blog post the pilot being tested over the past year already yielded "significant improvements" and enabled the center to more quickly address safety concerns.
He pointed to the example of a safety communication FDA issued in September advising physicians to not implant Alcon’s CyPass Micro-Stents due to a risk of patients to lose cells in the cornea of their eye.
FDA classified Alcon’s recall of the implant as Class I and advised eye care professionals to monitor patients with the product.
"The decision to immediately withdraw the device had been driven by data from one of two continuation studies ordered by the FDA as a condition of approval," Maisel and Shuren wrote. "In the new OPEQ structure, pre- and post-market teams work together within the same team, enabling them to work quickly and efficiently with the manufacturer to evaluate and compare data from the initial pre-approval and post approval studies."
FDA leaders said the new structure will also enable the agency to boost clinical evidence generation efforts throughout the entire lifecycle of a medical device.
"In OPEQ, we bring together previously separate efforts to assess clinical trial design, devise strategies for gathering real world evidence in high-quality registries, payer claims and electronic health records, and oversee the conduct of clinical trials to assure data integrity and human subject protection," they wrote.
Manufacturers also stand to benefit from the new structure.
Maisel and Shuren noted that during a recent premarket review of a novel device, the lead reviewer learned about a related inspection that helped FDA suggest the sponsor remove the supplier from their supply chain.
"This type of collaboration helps eliminate delays in getting innovative medical device technologies to the patients who need them," Shuren and Maisel wrote.
