Last week, our blog post advised planning a transition strategy in advance of the news of the termination of the Covid-19 public health emergency. On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here). Amongst CDRH’s highest prioritized …
“We still have a problem with COVID. We’re still doing a lot of work on it. But the pandemic is over. If you notice, no one is wearing masks. Everybody seems to be in pretty good shape. And so I think it’s changing.” President Biden made …
Nearly one year after FDA published a draft guidance on its Electronic Submission Template for Medical Device Submissions (see our blog post here), the Agency is back to formally introduce the widespread implementation of the electronic Submission Template And Resource (eSTAR) electronic submission template for …
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 …
Last month, former Theranos executives, Elizabeth Holmes and Sunny Balwani, convinced U.S. District Judge Davila to throw out criminal fraud charges, while denying other defense motions (see Judge Davila’s order here). The charges allege the pair misled patients on the basis that the government can’t …
CDRH has made commitments to stakeholders about completing reviews in a timely manner. For the fiscal year (FY) 2019, though, FDA acknowledged that it missed review-time goals for evaluating product recalls and Medical Device Reports (MDRs). FDA reviewed and classified recalls in a timely fashion …
About eighteen months ago, the government accused former Theranos founder Elizabeth Holmes and former Theranos president Ramesh “Sunny” Balwani of wire fraud and conspiracy, a scheme that fooled investors into providing more than $700 million to the then-promising blood-testing startup. In the latest development in US …
On November 5, 2019, the U.S. District Court for the Northern District of California ruled in favor of Theranos founder Elizabeth Holmes and former Theranos president Sunny Balwani, in a battle over access to government documents. While this represents a small victory for these defendants, …
Nearly three years after Section 3060(a) of the 21st Century Cures Act amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by removing certain software functions from the device definition in section 201(h) of the FD&C Act, FDA has released Changes to …
There is little or no debate that patients are the experts on their own diseases. The FDA has promoted this concept for years and on September 24, 2019, the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) …
On December 17, 2018, FDA published a final rule, Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures, to amend its regulations governing classification and reclassification of medical devices to align with the relevant portions of the Federal Food, Drug, …
The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) recently announced a new voluntary pilot program to streamline review of 510(k) submissions for ophthalmic optical coherence tomography (OCT) devices. OCT devices are devices that are used for viewing, imaging, measurement, and analysis …
Since our last post on Digital Health, FDA has continued their public campaign to raise awareness and seek input on the Software Precertification (Pre-Cert) Program. This blog post covers topics that don’t affect only software companies. While the focus is on software, the potential implications …
The Center for Devices and Radiological Health (CDRH) says it has a plan for fostering digital health innovation while reimagining the regulatory oversight to provide patients with access to safe and effective digital health products. One step in the plan is developing a Digital Health …
The final Unique Device Identifier (UDI) Rule was published on September 24, 2013. The last phases of implementation related primarily to Class I and Unclassified devices. Due to complex issues identified during implementation of the UDI Rule for Class II and III devices, FDA is …
