New Year’s is often associated with baby New Year and with resolutions, which in a convoluted way got us thinking about post-approval pregnancy studies. Lots of us start the new year with a resolution. Is it a commitment, or a requirement, and does the difference …
It’s the moment we’ve all been waiting for, dreading, anticipating . . . . Today, FDA released a copy of a proposed rule to regulate laboratory-developed tests (LDTs), which is scheduled to be published in the Federal Register on October 3rd. The proposed rule has a …
On August 3rd, FDA issued 11 warning letters to foreign facilities registered as OTC drug manufacturers. For each of these facilities, FDA did not conduct an on-site inspection of the facility prior to issuing the warning letter. Instead, FDA issued a request for records pursuant …
FDA has been clearing over-the-counter (OTC) in vitro diagnostic (IVD) tests nearly since the beginning of its premarket regulation of devices. The first OTC IVD cleared by FDA was a qualitative dipstick urine glucose test in 1977, followed shortly thereafter by the first OTC pregnancy …
On June 1, CDRH announced that it is seeking public comment on questions regarding how CDRH can facilitate access to medical technologies designed for use outside of traditional clinical settings, particularly in the home. According to the announcement, enabling patients to access medical devices beyond …
The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn. In the most recent Unified Agenda, which is a list of planned regulatory actions published semi-annually by the Office of Management and Budget (OMB), FDA announced its intent to …
On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. A DCT is a clinical trial where some or all of the trial-related activities, such as administration of the investigational product, data collection, or …
On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming …
On October 21, 2022, FDA published a draft guidance document titled Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care. This draft guidance proposes updates to FDA’s Breakthrough Devices Program, which is outlined in a separate December 2018 guidance …
On August 9, 2022, the Secretary of the Department of Health and Human Services (HHS) declared the outbreak of monkeypox virus a public health emergency (see announcement here). On September 7, 2022, the Secretary of HHS declared that “circumstances exist justifying the authorization of emergency …
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 …
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 …
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 …
After 23 years, de novo classification review finally has an implementing regulation! The other major review processes have had their regulations in place for many decades. The Medical Device Amendments of 1976 created the initial premarket application (PMA) review and 510(k) substantial equivalence review processes. Only …
As surveyed in detail by our colleagues in an earlier blog post, FDA’s PDUFA VII goals letter, for fiscal years 2023-2027, is full of announcements and new agency initiatives. One of those announcements is a commitment to create a new process for reviewing sponsor-initiated requests …
