FDA names 107 devices it will exempt under new guidelines

The new draft guidance is the result of the Agency’s 2012 pledge during negotiations of the Food and Drug Administration and Innovation Act to propose low-risk medical devices that could be exempted from premarket notification.  It allows a device that was previously required to submit a 510(k) to be marketed without a review as long as it meets all other regulatory requirements, such as product registration and appropriate labeling.  The list includes Class II (medium risk) and Class I (low risk) medical devices and, the Agency said in its guidance, allows products that are “…sufficiently well understood and do not present risks that require premarket notification review to assure their safety and effectiveness…” to be exempt from the 510(k) process.

The list includes device categories as follows:  portable air compressors; fluid-filled teething rings; surgical lights; and obstetrical forceps.  Specific devices already on the market that would fall into such categories include the Pulmo-Aide Compressor Nebulizer System, water-filled teethers, and the Scintillant Surgical light.

The Agency has long been looking at ways to revamp its system for approving low-risk medical products. Previously, the FDA released a list of 25 actions that will improve the 510(k) system, including the creation of the Center Science Council to help standardize the review process and streamlined processes for lower-risk devices.

Comments on the draft guidance will be accepted during the 60-day comment period that began on Aug. 1.

REFERENCE:  Fierce Medical Devices; 4 AUG 2014; Joseph Keenan

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