It has been highly anticipated that FDA was planning to issue a new proposed rule on laboratory developed tests (LDTs) with suggestions that a proposed rule could come in by the end of this week. The expectation clearly signaled by FDA over the past years, and the past year in particular, was that FDA was seeking broader regulatory oversight over LDTs. The FDA clearly is seeking broader regulatory oversight in this proposed rule released today per a FDA news release. The content of this unpublished proposed rule can be found here at the Federal Register. A published rule would be expected to follow with the opportunity for commenting open to the public.
There is a lot of content to cover in this 84 page proposed rule and this is by no means an in depth analysis. This late breaking commentary is looking to capture a few of the many high level points raised per the proposed rule:
- FDA plans to amend CFR part 809 subpart A, specifically 809.3, to update the definition of “in vitro diagnostic products” to make explicit that IVDs are devices under the FD&C Act including when the manufacturer of the IVD is a laboratory (per pages 33-34 of proposed rule):
- “We are proposing to amend part 809, subpart A, specifically § 809.3, by updating the definition of “in vitro diagnostic products” to make explicit that IVDs are devices under the FD&C Act including when the manufacturer of the IVD is a laboratory. IVDs are defined as those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body” (§ 809.3). This amendment would reflect FDA’s longstanding view that LDTs are devices under the FD&C Act, and would reflect the fact that the device definition in the FD&C Act does not differentiate between entities manufacturing the device. In other words, whether an IVD is a device does not depend on where or by whom the IVD is manufactured.”
- FDA plans to end the general enforcement discretion policy to LDTs but understand bringing LDT manufacturers into compliance will take time (per page 47 of proposed rule):
- “Based on the considerations set forth in this preamble, FDA is proposing to end the general enforcement discretion approach for LDTs. However, FDA also recognizes that many IVDs manufactured by laboratories are currently being marketed as LDTs, and that a sudden change could negatively affect the public, including patients and industry. In particular, FDA understands that the healthcare community and patients have been using these IVDs, and that coming into compliance will take time for manufacturers.”
- FDA plans a phased approach to ending the general enforcement discretion policy to LDTs (per pages 58-59 of proposed rule):
- “As previously discussed, FDA is proposing to gradually phase out its current general enforcement discretion approach so that most IVDs offered as LDTs would generally fall under the same enforcement approach as other IVDs. In developing the proposed phaseout policy, FDA has considered a number of factors, including the public health importance of better assuring the safety and effectiveness of IVDs offered as LDTs, the desire to avoid undue disruption to the testing market, the time it may take for laboratories to come into compliance with FDA requirements, the need for adequate resources to implement the phaseout policy in a manner that does not undermine reasonable expectations with regards to premarket review timing (per the Medical Device User Fee Amendments (MDUFA) V agreement), and the benefits of a relatively simple policy that can be easily understood and implemented. Keeping these factors in mind, FDA has structured the phaseout policy to contain five key stages:
- Stage 1: End the general enforcement discretion approach with respect to MDR requirements and correction and removal reporting requirements 1 year after FDA publishes a final phaseout policy, which FDA intends to issue in the preamble of the final rule.
- Stage 2: End the general enforcement discretion approach with respect to requirements other than MDR, correction and removal reporting, QS, and premarket review requirements 2 years after FDA publishes a final phaseout policy.
- Stage 3: End the general enforcement discretion approach with respect to QS requirements 3 years after FDA publishes a final phaseout policy.
- Stage 4: End the general enforcement discretion approach with respect to premarket review requirements for high-risk IVDs 31⁄2 years after FDA publishes a final phaseout policy, but not before October 1, 2027.
- Stage 5: End the general enforcement discretion approach with respect to premarket review requirements for moderate risk and low risk IVDs (that require premarket submissions) 4 years after FDA publishes a final phaseout policy, but not before April 1, 2028.”
- “As previously discussed, FDA is proposing to gradually phase out its current general enforcement discretion approach so that most IVDs offered as LDTs would generally fall under the same enforcement approach as other IVDs. In developing the proposed phaseout policy, FDA has considered a number of factors, including the public health importance of better assuring the safety and effectiveness of IVDs offered as LDTs, the desire to avoid undue disruption to the testing market, the time it may take for laboratories to come into compliance with FDA requirements, the need for adequate resources to implement the phaseout policy in a manner that does not undermine reasonable expectations with regards to premarket review timing (per the Medical Device User Fee Amendments (MDUFA) V agreement), and the benefits of a relatively simple policy that can be easily understood and implemented. Keeping these factors in mind, FDA has structured the phaseout policy to contain five key stages:
Further analysis of this LDT proposed rule will come in the future at this site. The issuance of this proposed rule is clear signal to all LDT manufacturers that LDTs will be regulated by FDA as medical devices in the future and they should begin to prepare themselves for this situation. All affected parties should take the opportunity to enter the comments to this proposed rule once it opens up to commentary.
