On July 28, 2014, the Food and Drug Administration (“FDA”) issued final guidance regarding the agency’s substantive review of Traditional
Below we summarize the key points from the guidance, discuss how FDA responded to criticisms of the draft version of this guidance, and describe further actions that remain to be completed as part of FDA’s
Key Points from the Guidance
The new guidance is FDA’s first update to the 1986 “blue book” document, “Guidance on the CDRH Premarket Notification Review Program,
Elimination of split predicates. The guidance states that the use of a “split predicate” is inconsistent with the
Designation of a “primary predicate.” Unlike split predicates, FDA will accept multiple predicates in some circumstances. Multiple predicates are commonly relied upon when a
Explanation of “reference devices.” The guidance discusses the use of “reference devices,” which, like the term “primary predicate,” does not appear in the statute or FDA regulations. Reference devices are legally marketed devices, other than the predicate device(s), that are referred to in a
Definitions of “intended use” and “indications for use.” FDA has long recognized a distinction between the “intended use” of a new device, which must be the same as the intended use of the predicate device, and the “indications for use” of a device, which may differ to some extent between the new and predicate device. In the guidance, FDA defines “intended use” to mean the “general purpose of the device or its function,” whereas “indications for use” means “the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended.” FDA also repeats the point it has made elsewhere that a manufacturer’s intended use for a device can, in some cases, be determined by facts and circumstances outside the
Determining whether new “indications for use” constitute a different “intended use.” According to the guidance, FDA may find that changes in indications for use constitute a different intended use when they raise a safety or effectiveness issue not raised by the predicate or have the potential to significantly increase a safety or effectiveness concern raised by the predicate. The guidance contains several illustrative examples of how FDA applies this concept. It also asserts that FDA may rely upon publicly available scientific information or FDA knowledge about how a disease progresses to determine whether indications to treat a certain disease or anatomical site constitute a new intended use.
Determining whether differences in technological characteristics raise different questions of safety and effectiveness. Where differences in the technological characteristics of a new device raise different questions of safety and effectiveness, the new device is not substantially equivalent to the predicate. The guidance describes a logic scheme by which FDA identifies the technological characteristics of a device, compares them against those of the predicate device, and then determines whether there are differences in technological characteristics that raise different questions of safety and effectiveness. FDA states that a “different question of safety and effectiveness” is a question “raised by the technological characteristics of the new device that was not applicable to the predicate device, and poses a significant safety or effectiveness concern for the new device.” Similar to the section of the guidance addressing indications for use, this section of the guidance relies largely on illustrative examples.
Performance data requirements. If the new device described in a
Encouraging
Encouraging greater transparency in
Responses to Criticisms of the Draft Guidance
On December 27, 2011, FDA announced the availability of a draft version of the
- Expand the discussion of the use of predicate devices and the reasons for defining a “primary predicate”;
- Add examples to several sections to clarify FDA’s decision-making process for finding devices substantially equivalent despite differences in indications for use, technological characteristics, or performance characteristics;
- Add an appendix with a sample
510(k) Summary to demonstrate that level of detail FDA expects; and - Remove sections of the draft addressing Special
510(k) s and Abbreviated510(k) s, due to the relationship between Special510(k) s and planned FDA guidance on submitting a new510(k) for a device modification.
What’s Next?
It appears that criticism of the
Although it has now finalized the
- Issuing new draft guidance on when modifications to a device are significant enough to require a new
510(k) , after having been required by Congress to withdraw its previous draft guidance from August 2011 on this subject; - Issuing new guidance on Special and Abbreviated
510(k) s; and - Considering comments received in response to the recent draft guidance, “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [
510(k) ] with Different Technological Characteristics.”
In addition, FDA in the past has stated that it intends to develop new regulations relating to the transfer of ownership of
For more information, please contact any member of Ropes & Gray’s FDA regulatory practice or your usual Ropes & Gray Advisor.
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