In late December, as cases of Omicron were soaring, CDRH issued two draft guidance documents to prepare for the end of the public health emergency.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 …
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 …
Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here). The COVID-19 pandemic cannot keep us from actively facilitating Externally-Led Patient-Focused Drug Development (EL-PFDD) meetings with the Food …
Last November, we explained FDA’s role in blocking over-the-counter (OTC) rapid antigen tests from the American market. We identified as the main culprit FDA’s requirement that these tests achieve 80% sensitivity (positive percent agreement or PPA) even when a required percentage of low positive patients …
Closed-loop control systems, which adjust device output based on information received from a sensor to keep a variable at a reference position, are common in many medical devices. There are numerous examples where device output is controlled to maintain a physical measurement, such as pressure, …
On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. This discussion paper is not the first time that FDA …
Hyman, Phelps & McNamara, P.C. (HP&M) is pleased to announce Adrienne R. Lenz has become its first Principal Medical Device Regulation Expert. Adrienne joined HPM in September 2017. In her time with HPM, she has made significant contributions to the firm and its clients. Prior to joining …
As we approach our third year of COVID, one of the major questions from March 2020 eerily echoes today: where are all the COVID tests? The situation now, of course, is very different and much more favorable than two years ago. Unlike March 2020, numerous …
On December 23, 2021, CDRH released as a draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions (Draft Guidance). Computational modeling and simulation (CM&S) can sometimes be useful to demonstrate the safety and effectiveness of medical devices or incorporated into …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Adrienne Lenz will be speaking on Deciphering New and Proposed Regulatory Guidances For Medical Devices and Diagnostics at the Q1 Productions 4th Annual Life Science Regulatory Intelligence Virtual Event being held January 24-25, 2022. The …
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 …
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 …
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 …
Sixteen years after the publication of the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005, FDA issued a new draft guidance document on November 4, 2021 that describes the recommended documentation that a sponsor should include …
In England, over‑the‑counter (OTC) rapid antigen tests for COVID are widespread and available at low cost. In America, these tests are scarce and relatively high‑priced. Why is that? Background Rapid tests for COVID-19 are fast, inexpensive to manufacture, and a relatively easy method to detect the presence …
