There is a lot to unpack in the 430 pages of FDASLA, which means that some provisions are falling a little under the radar. One of those provisions is an unusual one in which Congress directs FDA to issue final rules concerning Over-the-Counter hearing aids. …
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 …
As the User Fee Acts move through Congress, it has been clear that FDA is using them as a vehicle to legislatively overturn some big court losses over the last few years. As faithful readers of our blog know, FDA’s broad interpretations of its governing …
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 …
On June 14-15 in Washington, DC, the Food and Drug Law Institute (FDLI) will hold its first in-person Annual Conference since 2019. The conference brings together leading regulators and a wide range of stakeholders to discuss current issues and trends of importance to FDA-regulated industries. …
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 – …
On March 22, FDA announced that it reached agreement with representatives from the medical device industry on proposed recommendations to Congress for the fifth reauthorization of the Medical Device User Fee Amendments (MDUFA V). MDUFA authorizes FDA to collect fees from certain medical device applicants …
One of the more complex areas of device regulation is the management of risks associated with malfunctions reported from the field. A critical task in this situation is for a firm to estimate the risk posed by the issue as accurately as possible. This estimation …
Legislation has been proposed in Congress that would require FDA to regulate all contrast agents as drugs even though two courts determined that doing so clearly contradicts the plain language of the Federal Food Drug and Cosmetic Act (“FDC Act”). Unless amended, the proposed legislation …
It’s not often that FDA issues an “Immediately in Effect Guidance,” but it’s not often that a case like Genus v. FDA comes along and upends twenty years of FDA practice. Almost a year after the D.C. Circuit held that products that simultaneously meet both …
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, …
