The request for comments notes that the committee held a roundtable on personalized medicine on July 23, 2014, and a meeting specific to the FDA's proposal to regulate LDTs on September 9, 2014. (For my coverage of the latter, see here, including a very detailed discussion report, here.)
I've also cut-pasted the eleven questions in full, below the break.
Update: One publicly available response is the AMA's, dated 1/5/2015, here.
What follows is the Committee's December request for comments on 11 issues. Please note, the headers to each question (in capitals) are my own addition, and they were not part of the original document from the committee.
What follows is the Committee's December request for comments on 11 issues. Please note, the headers to each question (in capitals) are my own addition, and they were not part of the original document from the committee.
1. LINES: TEST, KIT, PRACTICE OF MEDICINE
Multiple
stakeholders have expressed the urgent need to have clear and logical lines
separating the practice of medicine, the actual conduct of a
diagnostic test and the
development and manufacturing of diagnostic tests. How
should these lines be
defined and what are the key criteria separating each of
these activities?
2. IS AN LDT A DEVICE?
In FDA’s draft
regulatory framework, the agency describes the extent to which it
proposes to regulate LDTs as medical devices under the
Federal Food, Drug, and
Cosmetic Act (FFDCA). It is relatively clear with respect to
distributed test kits what
constitutes a “device,” but less clear when considering a
test developed and
performed in a laboratory. What should comprise the “device”
subject to regulation
by the FDA?
3. HOW TO DEFINE RISK BASED?
FDA intends its
regulation of diagnostics to be risk-based. How should risk be
defined? Are the types of risks posed by diagnostic tests
different from therapeutic
medical devices? Are these risks different with LDTs
compared to distributed test
kits? Is the traditional medical device classification
system appropriate for these
products?
4. DO LEGACY "SAFE/EFFECTIVE" RULES MAP TO LDTs?
The current
pre-market review standards that apply to in vitro diagnostics use the
same terminology of safety and effectiveness that apply to
all medical devices.
Should the medical device concepts of safety and
effectiveness apply to test kits and
LDTs?
5. BALANCE OF PRE MARKET AND POST MARKET CONTROLS
Are there areas
where the balance between pre-market review versus post-market
controls should be reconsidered? How can post market
processes be used to reduce
barriers to patient access to new diagnostic tests?
6. HOW TO HANDLE MODIFICATIONS?
A number of
stakeholders have expressed concerns about uncertainty as to when a
supplemental premarket submission is required for a
modification. When should they
be required prior to implementing modifications? Should the
requirements for
submission of a supplemental clearance or approval differ
between LDTs and
distributed test kits?
7. LABELING FOR LDTs?
We have heard a
lot about the practice of medicine and its relationship with medical
product “labeling.” What should comprise “labeling” for
diagnostic tests? Should
different standards for dissemination of scientific
information apply to diagnostic
tests versus traditional medical devices? What about for
laboratories that develop,
perform, and improve these tests? Should there be regulatory
oversight of the
information that is provided to the individual patient or
health care provider or is that
the practice of medicine?
8. FDA VERSUS CLIA?
The Section 1143
guidance documents raise important questions about the
relationship between the FFDCA and the Clinical Laboratory
Improvement
Amendments (CLIA), administered by the Centers for Medicare
& Medicaid Services
(CMS). Is there overlap between the requirements of the
guidance documents and
CLIA? For instance, how do FDA’s quality systems regulations
compare with CLIA
quality systems requirements? Are there areas of duplication
where there would be
efficiencies to having either CLIA or FDA regulate, rather
than both?
9. RARE OR EMERGENCY DISEASES?
How should any
regulatory system address diagnostic tests used for rare diseases or
conditions, customized diagnostic tests and diagnostic tests
needed for emergency or
unmet needs (e.g. Ebola)?
10. TRANSITION TO LDT REGULATION?
Any new regulatory system will create transition
challenges. How should existing
products be handled? Should all current diagnostic tests be
“grandfathered” into the
marketplace? What transition process should be used for new
product introductions?
11. INCENTIVES FOR INNOVATION?
What incentives can be put in place to encourage the
development of new, more
accurate or more efficient diagnostic tests?
Please submit responses to cures@mail.house.gov by January 5, 2015.
