FDA Finalizes Rule to Simplify Medical Device Classification Procedures

Regulatory NewsRegulatory News | 13 December 2018 |  By 

The US Food and Drug Administration (FDA) issued a final rule Thursday to simplify its procedures for classifying and reclassifying medical devices.
FDA said the final rule clarifies that it can reclassify any device from class III—set for higher-risk devices or those automatically assigned to this category by operation of law in lieu of classification orders—to either class I or class II.
The final rule, proposed in 2014, takes advantage of the authority FDA received through 2012 amendments to the FD&C Act for changing device classification by administrative order rather than by rulemaking. It does not impact set procedures for a device reclassification via a submitted request (i.e. a de novo classification request). It does, however, make it easier for the agency to make changes on a classification based on new or changing information to better reflect the risk associated with the use of a device. This is partly because administrative orders are not subject to the lengthy comment periods that come with proposed rulemakings.
By aligning its regulations to the Food and Drug Administration Safety and Innovation Act of 2012 through the final rule, FDA can now move to reclassify a postamendments or a transitional device by publishing an administrative order in the Federal Register. Convening a panel to consult on a device reclassification is now optional, but comments can be submitted on a proposed order.
The final rule also removes the previosuly set requirement to provide two forms as part of a device reclassification petition because FDA “no longer finds the forms useful," the agency said. These are Form FDA 3429 (General Device Classification Questionnaire) and Form FDA 3427 (Supplemental Data Sheet).
Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures


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