Devices

Improving Dental Device 510(k) Submissions

A 10/2 CDRH Webinar offered recommendations for improving dental device 510(k) submissions. Office of Health Technology One acting assistant director Michael Adjodha said the “refuse-to-accept” rate for dental devices in the first round of review is above 80% and involves several issues that were discussed in the Webinar.

For 2018, Adjodha said, the greatest number of submissions were for dental abutments and endosseous implants, composite resins, orthodontic aligners, snoring and sleep devices, dental ceramics, resin bonding agents or cements, dental hand pieces, denture resins, and orthodontic software. About half the workload involves dental implants and abutments, he said.

“We would like to accept submissions we receive as administratively complete,” Adjodha said. “However, we continue to see challenges in one or more of the following areas that have prevented this.”

He identified problem areas as including deficiencies in device descriptions, failure to address recommendations of a device-specific guidance, deficient labeling and instructions for use, incomplete information about sterilization and processing, and failure to provide performance data test reports.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome