On September 15, 2023, FDA released a final guidance document titled “Breakthrough Devices Program.” Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities …
The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. The …
As we recently blogged, FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “Evidentiary Expectations for 510(k) Implant Devices.” Implant devices are used in a range of settings such as …
As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). There is much to unpack, and we intend to do so in a series of blog posts. In this post, we focus on the …
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 …
Over the last three and a half years, meetings with FDA were conducted virtually. During this time, CDRH moved from Webex to Zoom and gained experience with the virtual platform. Now, in addition to engaging with FDA via Zoom, medical device sponsors can once again …
On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents. This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: …
Following up on our first post discussing Digital Health Technologies (DHTs) (here), this post will focus on development and qualification of DHTs for use in clinical trials for drug development. Earlier this year, FDA hosted a public meeting, Understanding Priorities for the Use of Digital …
As part of FDA’s Prescription Drug User Fee Act (PDUFA) VII goals published in PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027 (PDUFA Goal Letter), which we blogged about here, FDA included a goal for enhancing use of digital health technologies (DHT) …
The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP). Through ELP, CDRH staff visit sites that provide formal training and enhance understanding on topics such as how products are developed and …
It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. But that is only the beginning. After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2nd …
Earlier this year, neither the Quality System Regulation (QSR) nor the Quality Management System Regulation (QMSR) were referenced in the semiannual regulatory agenda. We now see that the proposed rule to “harmonize and modernize” the QSR with ISO13485:2016, creating the new QMSR, is on the Spring …
The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions. Use of voluntary consensus standards can reduce regulatory burden, streamline conformity assessment, harmonize requirements globally, and enhance …
Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here). FDA now seeks comments on this very program to support its continued collection of information as …
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 …
