The FDA promised to finalize an expedited approval pathway for medical devices that address critical unmet needs and to officially expand its authority into the regulation of lab-developed molecular diagnostic tests in its annual list of upcoming medical device-related guidance documents for the new year.
Many of the planned guidance documents that it intends to publish are limited to niche and obscure topics like the submission and review of sterility information in 510(k) documents, as that tends to be the regulations' nature, but a new approval pathway and the expansion of regulation into the arena of laboratory-developed tests (LDTs) promise to be game changers. That means both are the subject of intense lobbying--or possibly even lawsuits in the case of the LDT guidance--and the final guidance may look significantly different from the draft version.
The proposed Expedited Access PMA pathway, described in last year's draft guidance, is intended for medical devices that treat an "unmet need for life threatening or irreversibly debilitating diseases or conditions."
AdvaMed took a surprisingly harsh stance on the industry-friendly measure, which could cut approval times by up to a third. "It is important to remember that Congress required the FDA to develop an expedited pathway for breakthrough devices under the FDA Modernization Act of 1997, and while the agency has developed guidance and procedures to fulfill this mandate, it has not succeeded in meeting Congress's intent," said Janet Trunzo, the trade association's senior executive vice president of technology and regulatory affairs, in a statement emailed to FierceMedicalDevices shortly after the issuance of the draft guidance in April 2014.
Meanwhile, company executives at last year's annual AdvaMed conference said they were hopeful that the types of devices that are subject to the expedited pathway can be expanded from those covered under the draft guidance. So, keep an eye out for that when the final guidance is issued later this year.
But it is the LDT regulations that are truly controversial.
For, when the FDA finally released its draft guidance on the oversight of lab-developed tests in July, it ended a 10-plus-year saga to mark its regulatory stamp in that arena, but created a new one over the guidance's implementation. That won't occur until the final guidance is released later this year, giving opponents like the American Clinical Laboratories Association (ACLA) an opportunity to make one last push against the new regulations, and the agency and its allies time to rally their forces.
If ACLA has its way, the final guidance won't be issued at all. In November, the trade association announced that it is retaining two prominent attorneys "for representation on matters relating to the Food and Drug Administration's recently issued draft guidance to regulate laboratory-developed tests as medical devices."
But the FDA made clear that it does not intend to back down by including the guidance "Framework for Regulatory Oversight of Laboratory Developed Tests" to its list of final guidance that it intends to publish in 2015. Barring a legal victory, ACLA will have to settle for attempting to modify the regulations to make them more friendly to its membership.
The FDA is required to post a list of all draft and final guidance that it intends to submit in the upcoming year under the Medical Device User Fee Amendments of 2012. There are about 25 guidance documents related to various subjects on this year's list. All are important, but only two are game changers.
- here's the list of all the guidance documents that FDA intends to submit in 2015