• where experts go to learn about FDA
  • Allyson B. Mullen

    • Pre-Submission Program Update from CDRH: A Bit of Welcome NewsJune 8th, 2022

      CDRH appears to be taking another step towards returning to pre-pandemic life.  On May 31, Drs. Shuren and Maisel announced that OHT7 (formerly OIR) will now be accepting all types of pre-submissions (see announcement here).  As you’ll recall from our earlier post (here), OHT7 had …

    • CDRH Returning to Pre-Pandemic Timelines for Premarket Submission HoldsJune 6th, 2022

      On June 3, FDA announced, via email to industry, that it plans to withdraw the guidance “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices–Questions and Answers (Revised).”  This guidance did two things: (1) automatically extended hold …

    • FDA Issues Safety Warning Regarding Non-Invasive Prenatal Testing Raising Questions About the Future of FDA Regulation of LDTsMay 25th, 2022

      On April 19, FDA issued a safety communication regarding genetic non-invasive prenatal screening, commonly referred to as non-invasive prenatal tests or NIPT (here).  NIPT are intended to screen for genetic abnormalities in a fetus.  The tests are not intended to diagnose any genetic conditions – …

    • CDRH Looks Towards the End of the Public Health Emergency and Transition for EUA and Devices Marketed Under Enforcement DiscretionMarch 8th, 2022

      In late December, as cases of Omicron were soaring, CDRH issued two draft guidance documents to prepare for the end of the public health emergency.  The pair of draft guidances laid out the transition for devices that are being marketed under an EUA and devices …

    • FDA Proposes to Harmonize the Quality System Regulation with ISO 13485March 7th, 2022

      On February 23, 2022, FDA published in the Federal Register a proposed rule that would replace the Quality System Regulation (QSR), at 21 C.F.R. Part 820, with a newly named Quality Management System Regulation (QMSR).  The QMSR omits many of the specific QSR requirements that …

    • What is Going on with the Pre-Submission Program?December 10th, 2021

      It seems like every other discussion I have these days someone asks, “what is going on with the pre-submission program?”  “I heard CDRH isn’t reviewing pre-submission,” or “I heard FDA is only providing written feedback and not holding meetings.”  So, we thought it was time …

    • HP&M’s Review of New CDRH Submission TrackerDecember 1st, 2021

      Earlier this fall, in accordance with its MDUFA IV commitments, CDRH launched an online platform that allows sponsors to track the status of its submissions.  The platform is called the Customer Collaboration Portal (CCP) and is “a secure, web-based tracker that displays the CDRH progress …

    • HHS Revokes Trump-Administration LDT PolicyNovember 29th, 2021

      On November 15, HHS announced that it was withdrawing the prior administration’s policy that prevented FDA from requiring premarket review of laboratory developed tests (LDTs) without notice and comment rule making.  See the prior post on this policy here.  This statement comes at least six …

    • FDA Issues Unsupported Safety Warning Regarding Surgical Robots for Cancer TreatmentOctober 15th, 2021

      In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use.  Gone are the days of tool type indications for this type of device.  Rather, …

    • New Administration, “Old” Rules: FDA and HHS Jointly Withdraw 11th Hour Trump Administration Proposal for Sweeping 510(k) ExemptionApril 22nd, 2021

      In a return to regular order, on April 16, HHS and FDA jointly withdrew a January 15, 2021 proposal issued by HHS under the prior administration recommending wide-spread 510(k) exemptions (the “Notice”).  See 86 Fed. Reg. 20167, 20174 (Apr. 16, 2021) (available here and here).  …

    • FDA Releases Examples of Real-World Evidence Used in Medical Device Decision MakingMarch 31st, 2021

      FDA has long said that it would consider real-world evidence (RWE) in making regulatory decisions related to medical devices.  Those in industry know that FDA can be very critical of RWE, however, and it is not always clear why RWE was (or was not) acceptable …

    • CDRH Issues Draft Guidance Regarding Patient Reported OutcomesSeptember 8th, 2020

      In recent years, FDA has sought to increase the patient perspective in its regulatory decision making.  One way this is accomplished is through use of patient‑reported outcome (PRO) measures in clinical studies.  PROs can assess concepts that are unobservable to clinicians and are only know …

    • CDRH Issues Draft Guidance on Safer Technologies ProgramSeptember 30th, 2019

      FDA formally announced the Safer Technologies Program (STeP) in a December 2018 press release from then-FDA Commissioner Scott Gottlieb, M.D., and Director of CDRH Jeff Shuren, M.D.  Details on the program were limited other than to say that the program would be designed to complement …

    • Congress Floats Discussion Draft of IVD LegislationFebruary 5th, 2019

      Since FDA announced in late 2016 that it would not finalize its laboratory developed test (LDT) guidances, it has become clear that any change to the LDT regulatory framework (at least during this administration) would need to come through a statutory change.  The first such …

    • Updated CLIA Waiver Guidances Lack Details in Original DraftJanuary 14th, 2019

      In the midst of the government shutdown and with its accompanying lull in new FDA documents, we thought it would be a good time to update our readers on some guidances that were issued late last year.  Two such notable draft guidances were the, “Select …