Question

According to the FDA, how many regulatory classes of medical devices currently exist, and what are the differences between them?

Answer 1

According to FDA there are three regulatory classes of medical devices based on their risk.

Class 1 Low risk equipment with simple design. include tongue depressor, bedding adhesive bandaids , wheel chairs, examination gloves etc .

Class 1 medical equipments do not require FDA approval but the device and company should be registered with FDA. Registration takes less than 1 month . Most are exempt from premarket requirements .

Cinical requirements - qyality and good manufacturing standards required .

Class ll moderate risk - more complex in design

Absorbable sutures and Blood pressure apparatus cuffs, catheters , needles, infusion pumps etc

FDA clearence needed via 510 k premarket notification submission . Typically takes 4 to 10 months for clearance as these products are tested and clinical data is required .

Clinical requirement -cumpolsory performance standards , quality and good manufacturing standards , post market surveillance.

Class lll high risk -

- implants , pacemakers , coronary stents , dental lasers .

FDA approval required via PMA (premarket approval processprocess . )Typically takes 36 months or more due to testing ,clinical trials , inspection of facility etc .

Clinical requirement - premarket approval submitted to CDRH for sceintific and clinical review . Based upon performance CDRH recommends the product to FDA for approval.

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