AMDM 2017: A Look Back
The Association of Medical Diagnostics Manufacturers (AMDM) held its annual meeting April 24-27, with OIR Submissions and Pre-Submissions workshops April 24-26. The Beaufort team was there…here is the top news from the meeting:
Rejected: Leftover Specimens Rule Change
During the Diagnostics Update session by Khatereh Calleja, JD, senior vice president of Technology & Regulatory Affairs at AdvaMed, it was confirmed that the controversial leftover specimens rule change was removed from the Common Rule (The Federal Policy for the Protection of Human Subjects). Originally published in 1991, the Common Rule safeguards individuals who participate in research. In September 2015, HHS and the other Common Rule agencies published a Notice of Proposed Rulemaking (NPRM), including a provision that would have required researchers to obtain consent before using a study participant’s non-identified biospecimens.
Inspired by the case of Henrietta Lacks, a poor black woman whose cancer cells became widely used in research labs without her or her family’s consent, the proposed change would have required written consent for broad future use of such deidentified samples. At great cost, institutions would have had to set up systems to track the consent data, which likely would have prevented many small hospitals and clinics from providing samples for research. This was definitely a win for the research community.
(Side note: I highly recommend all clinical researchers read The Immortal Life of Henrietta Lacks by Rebecca Skloot.)
FDA’s Bioresearch Monitoring (BIMO) investigators are seeing an increase in studies using leftover samples that are conducted without documented Institutional Review Board (IRB) approval. IRB approval is required when a sponsor performs a study in support of a pre-market approval application that will be submitted to FDA. Beaufort clients can rest assured that their studies receive appropriate IRB approvals and other required documentation.
Triggers for BIMO inspections remain:
- Premarket application user fee submitted
- New or novel technology
- Study performed in a vulnerable population
- Surveillance (IRBs, CRO, and GLP)
- Complaint received at FDA from a patient or disgruntled employee
OIR Still Holding on LDT Oversight Policy
OIR Director Alberto Gutierrez, Ph.D., gave an update on the agency’s work on developing a new oversight policy for Laboratory Developed Tests (LDTs). He explained in December that FDA will wait until the new White House administration is in place before updating the LDT framework and will continue enforcement discretion.
FDA was asked by Congress not to publish final guidance or a white paper. The agency issued a discussion paper in January, but is not likely to publish anything further. Gutierrez commented that Congress stepping in will be the easiest way to resolve the issue and that he does not believe that FDA will be the determining factor.
Pre-Submissions: A One-Round Thing
During the Roundtable Discussion with OIR Management Team, Courtney Lias, Ph.D.,
director of the Division of Chemistry and Toxicology Devices at FDA, made an interesting comment regarding pre-submissions: they are meant to be a one-round thing. Some companies submit a lot of unnecessary pre-submissions. If you are not sure if you need a pre-submission, contact FDA first to inquire, or look to the recently cleared 510(k) summaries for good case studies about what’s needed. Director Gutierrez reiterated that OIR is always willing to interact.
The message here remains the same: talk to FDA. The new emphasis is on being cognizant of when a pre-submission is needed and when it’s not. And, use case studies as guides so the process is efficient. If you need a pre-sub, try sticking to just one. At Beaufort, this is something we regularly help our clients with. If you need help determining when to submit and when to hold back, we can guide you through the process.
IVDR: Technical Documentation Review Is the New Norm
There were two sessions on the new In Vitro Diagnostic Regulations (IVDR) in the European Union, which will take effect by the end of June. The first session described the increased regulations—and workload—for manufactures; the second session described the extra work for Notified Bodies (NBs).
The main takeaway was that under the current In Vitro Diagnostic Directive (IVDD) 80 percent of IVDs do not have their technical documentation reviewed by an NB. Under the new IVDR, the opposite will be true: 80 percent of IVDs will require technical documentation review by an NB. Carol Ryerson, principal advisor at RCRI, recommended that manufacturers read the entire IVDR and that they write their reports as if the NB did not have access to any other documents.
Beaufort experts can help guide you through these changes to ensure that your technical documentation meets all the requirements on the NB’s checklist.