The U.S. Food and Drug Administration has issued new draft guidance that would exempt certain Class I and Class II medical devices from premarket, or 510(k),submission requirements. If a device is “exempted from premarket notification,” then the FDA would allow a device that was previously required to submit a 510(k) application to simply be marketed without a review, provided all other regulatory requirements are met.
The FDA believes devices identified in section 4 of this guidance document are sufficiently well understood and do not present risks that require premarket notification/510(k) review to assure their safety and effectiveness.
The guidance document is distributed with the intent of seeking comments only. Comments and suggestions may be submitted until the end of September.
