FDA敲定旨在简化医疗器械分类程序的最终规则

美国食品药品监督管理局（FDA）于2018年12月13日发布了旨在简化医疗器械分类和重新分类程序的最终规则。

FDA表示，该最终规则明确规定，其可以将任何器械从III类（高风险器械或依法自动归为此类而不是根据分类规则归为此类的器械）重新归类为I类或II类。

FDA早在2014年就提出了该最终规则，并凭借其通过《联邦食品、药品和化妆品法案》（FD&C Act）（2012修订版）获得的授权敲定了该最终规则，通过行政命令而不是通过规则制定来变更器械分类。该最终规则不会影响那些根据已经提交的请求（即de novo分类请求）对器械进行重新分类的既定程序。然而，该最终规则确实有助于FDA根据新的或不断变化的信息对分类进行变更，以便更好地反映与器械使用相关的风险。部分原因在于行政命令不受拟议规则制定后可能出现的冗长的讨论和评审阶段的影响。

最终规则的发布，使其规定与《2012年美国食品药品监督管理局安全及创新法案》保持一致，那么，FDA当下可以通过在《联邦公报》（Federal Register）上发布行政命令，对修正案后器械（1976年5月28日后合法上市的器械，Postamendments Device）或过渡性器械（1976年5月28日前被FDA作为新药管制的器械产品，Transitional Device）进行重新分类。现如今，FDA可以选择召集一个专家小组，就器械重新分类进行协商，而且可以就提出的行政命令提交评论意见。

FDA表示，最终规则也取消了器械重新分类申请中需要提供两个表格的要求，因其认为“这些表格不再有用”，即FDA 3429表格（一般设备分类调查表）和FDA 3427表格（补充数据表）。

FDA Finalizes Rule to Simplify Medical Device Classification Procedures

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, the agency can now move to reclassify a postamendments device 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 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).