Allegations of regulatory misconduct are claims that a medical device manufacturer or marketers of medical devices operate in such a way that violates the law. Allegations may include failure to register and list a medical device, promotion of a device outside the scope of its …
On September 28, 2022, FDA published its long-awaited final guidance document entitled “Clinical Decision Support Software,” which interprets the medical software provisions of the 21st Century Cures Act (Cures Act). The final guidance was preceded by two iterations of draft guidance—one in 2017 and one in …
The New Jersey Supreme Court, in its August 25, 2022 opinion in Mirian Rivera v. Valley Hospital, Inc., 2022 N.J. LEXIS 679 (NJ Aug. 25, 2022), https://www.njcourts.gov/attorneys/assets/opinions/supreme/a_25_26_27_21.pdf?c=lmL, considered whether a provider’s use of a medical device that is the subject of an FDA safety communication …
Similar to what was done with COVID-19, the National Institute for Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative has established a Monkeypox Independent Test Assessment Program (ITAP) and it currently accepting new proposals on a rolling basis to address the outbreak. The program began …
FDA recently published Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List under the 21st Century Cures Act in the Federal Register (FR Notice). By way of background, 21 C.F.R. § 4.3 requires generally that manufacturing of a …
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 …
As promised in our posts from earlier this summer (here and here), we are back to report on our assessment of CDRH’s electronic submission process through its Customer Collaboration Portal (CCP). In short, the process is FANTASTIC! Say goodbye to your thumb drives and CDs …
It’s been almost 11 years since FDA first clarified use of multiple predicate devices and introduced the concept of Reference Devices in the draft guidance titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], which we blogged about here. The final guidance with …
After 5 long years, FDA has finally adopted the long-awaited OTC hearing aid rules. While the Proposed Rule was a year and a half overdue, FDA impressively turned out the Final Rule about 7 months after the close of comments on the Proposed Rule, which …
Those of us who work frequently on FDA inspections of drug and medical device manufacturing facilities have noticed an uptick in regular inspections after a dramatic falloff during the first two years of COVID. That impression was corroborated this week at the GMP by the …
The American Conference Institute is hosting their 39th FDA Boot Camp from September 14-15, 2022. The conference will be held virtually. Gain insight and training in core regulatory concepts for life sciences attorneys, business executives, and policy analysts. The approval process, pre-approval concerns, product labeling, clinical trials, …
Happy Birthday Laboratory Developed Tests (LDTs). Thirty years ago today, FDA announced that it had the authority to regulate you. Not yet understanding how important you’d become, you entered the regulatory world without a name – the Agency simply referred to you as “home brew” products. …
On July 19, 2022, CDRH announced to users of its Customer Collaborations Portal (CCP) that it is now accepting premarket submissions electronically. This came quickly after an announcement was made earlier in the summer that this functionality would soon be enabled for existing users of …
Last month, FDA announced two important steps towards accepting electronic 510(k) submissions. The first relates to the Customer Collaborations Portal (or CCP). As discussed in our prior post on the CCP (here), the CCP is currently a submission tracker providing details of completed and upcoming …
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. …
