By Kirell Lakhman

The FDA in June opened a two-month period for stakeholders to comment on its plan to improve its 510(k)-review and -approval process.

As it notes in its comment invitation, the agency stresses that "[s]ince its inception, the 510(k) process has undergone a number of statutory changes" and that the it "has modified its implementation of the process to adapt to changing circumstances and accommodate the evolving medical device landscape."

Alas, it hasn't been nimble enough to keep pace with the "changing circumstances" and wants to change the process with the goal of "making available to consumers devices that are safe and effective, and fostering innovation in the medical device industry."

Clinical labs, test makers, and other stakeholders have until Aug. 15 to submit comments to the FDA's proposal, which is divided into two volumes: one entitled "Center for Devices and Radiological Health Preliminary Internal Evaluations" and the "Center for Devices and Radiological Health Preliminary Internal Evaluations."

As I first reported on the proposal last week, its goal is to formulate and release "recommendations" to "focus on innovation, regulatory predictability, and patient safety."

The FDA had also said the recommendations aim to "strengthen and clarify" the 510(k) review process for certain medical devices and to "seek to strike the right balance between [its] ability" to deal with "new science … and to provide predictable regulatory pathways" — topics that have had front-row seats to the ongoing debate over the agency's controversial contrivance to regulate LDTs as medical devices.

When I first reported on the FDA's 510(k) proposal, I said it must keep in front of mind these LDT changes. (See here and here for past posts describing why.)

Anxious Limbo

As far as its 510(k) plan goes, it remains "preliminary," and the FDA has stressed it "has not made any decisions on specific changes to pursue."

With those ends in mind the agency has begun "soliciting public input on the recommendations in these reports, including the feasibility of implementation and potential alternatives."

Once it gathers and digests these comments the agency will excrete at an as-yet undisclosed date "which improvements it will implement, as well as projected timelines for implementation."

Stakeholders can submit their comments in writing to:

The Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

They can also ring Philip Desjardins at CDRH at 301-796-5678 to query about commenting electronically.

As I noted in my previous post on the subject, the FDA, in a minor mea culpa, said "[i]n recent years, concerns have been raised within and outside of FDA about whether the current 510(k) program optimally achieves [the] goals … of making available to consumers devices that are safe and effective, and fostering innovation in the medical device industry."

Devising a 510(k) process version 2.0 is a good start and could conceivably contribute to a fair and sensible dénouement to the agency's open-ended LDT-regulatory scheme, which has left many in the clinical lab community in a state of anxious limbo.

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