Hearing Aid Maker Says 483 Prompted New Mindset on MDRs

Sonic Innovations is taking a more conservative view of FDA regulations on reportable events after getting an FDA Form 483 for lapses in complaint handling and reporting procedures.

In the wake of the FDA’s Jan. 18-23 inspection of its Eagan, Minn., plant, Sonic now believes a more careful approach to 21 CFR 803 — the agency’s 15-year-old medical device reporting (MDR) regulation — is “better than arguing with regulators,” Michael Jeltema, the hearing aid maker’s quality assurance manager, said.

Sonic has also moved to more frequently review the agency’s MDR database, known as the Manufacturer and User Facility Device Experience database, Jeltema said.

While Sonic was able to learn from its inspection and Form 483, many devicemakers can’t seem to grasp the urgency needed in correcting problems and responding to the FDA.

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