FDA opts not to change device class definitions

The medtech industry appears to have won a round in the regulatory arena.

The FDA issued a final rule amending its regulations on classifying and reclassifying medical devices under the Food and Drug Administration Safety and Innovation Act (FDASIA), passed in 2012. Published today in the Federal Register, the rule says it “provides for the classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation.”

When it was proposed in 2014, the rule drew comments from the industry arguing that the changes in definitions would result in more devices being classified into “burdensome, higher-class device categories, particularly into class III.”  Other commenters said the changes would make class definitions too specific and narrow, particularly for class III devices. This could lead to “unwarranted reclassification of high-risk devices into lower classes,” the document says.

AdvaMed and the Medical Device Manufacturers Association were among those that warned the definition changes would result in more devices being classified as posing a high risk to human health.

“MDMA is concerned that the Proposed Rule creates an unjustified and, indeed,
what we believe is an unlawful burden on industry that will result in significant delays in patient access to critical new products,” the organization wrote.

In its objection, AdvaMed wrote that the proposed changes amounted to “substantial rewriting of the device class definitions, changes in well-settled terminology, and new definitions with likely significant impact on the reclassification process.”

“We believe that unsettling longstanding understandings of the classification
process and attempting to integrate decision-making criteria into definitions that do not need clarification is a dangerous practice that can create confusion, inefficiency and weak decision-making for both the regulators and regulated persons,” AdvaMed continued. “In other words, we believe the proposed revisions will cause confusion where there was none.”

Others said that the proposed definition of class II was too broad and that it would capture devices that they thought should be regulated as class III.

In the end, the FDA decided not to finalize any of the proposed definition changes.

“We do not believe, given the volume and diversity of opposing comments, that finalizing these definitions would add clarity or transparency to stakeholders’ understanding” of the regulation, the agency said.

The decision to pull back on its definition changes was the second in two weeks that could affect the classification of devices. Last week, the FDA published a new proposed rule looking to establish procedures and criteria for its De Novo certification pathway.

If finalized, the rule would establish classifications for new types of medical devices and provide guidelines for the de novo classification process. It would also establish requirements for the formatting and content of de novo requests and would clarify the agency’s criteria for approval, declining and withdrawing such requests.

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