FDA began the Software Precertification (Pre-Cert) pilot program in 2017 to evaluate an alternative approach to regulation of software as a medical device (SaMD) over the total product lifecycle (TPLC). We have followed it over the last five years, with blog posts here, here, here, …
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 …
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since FDA first clarified use of multiple predicate devices and introduced the concept of Reference Devices in the draft guidance titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], which we blogged about here.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 …
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, …
On December 23, 2021, CDRH released as a draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions (Draft Guidance). Computational modeling and simulation (CM&S) can sometimes be useful to demonstrate the safety and effectiveness of medical devices or incorporated into …
FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency. An eCopy is an electronic copy of the 510(k) that is comprised …
Over the past several years, FDA has faced criticism stemming from high-profile device issues related to materials, including the Essure permanently implanted birth control device and metal-on-metal hip implants. Given this, it is not surprising that device biocompatibility has received greater focus in FDA premarket …
On January 12, 2021, FDA issued an Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (“AI/ML Action Plan”) and a discussion paper on their Proposed Regulatory Framework for Modification to Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical Device …
On December 4, 2020, FDA finalized the guidance document, Requesting FDA Feedback on Combination Products (Guidance), which was issued to fulfill the requirement under Section 3038 of the Cures Act. As a reminder, Section 3038 contained several provisions to help facilitate FDA engagement and appropriate …
On September 22, FDA announced the creation of a Digital Health Center of Excellence (DHCoE), which has grown out of their existing Digital Health Program. The objectives of the DHCoE include connecting and building partnerships, sharing knowledge and innovating regulatory approaches related to digital health. …
FDA’s Software Pre-Certification (Pre-Cert) Program is intended to create a new streamlined regulatory process for software as a medical device (SaMD) (see our earlier blog posts on the program here, here, here, here, and here). On September 14, 2020, FDA updated the Digital Health Software …
You’ve seen the news about insufficient supply and availability of ventilators to treat patients with Coronavirus Disease 2019 (COVID-19). You’ve also likely seen news of ideas to mitigate this shortage. On March 24, 2020 FDA issued an Emergency Use Authorizations (EUA) for ventilators, anesthesia gas …
On September 27, 2019 FDA issued several updates to advance their digital health policies. One of these updates was a new draft guidance, Clinical Decision Support Software (“Guidance”). This draft guidance replaces the 2017 draft guidance, Clinical and Patient Decision Support Software (“Prior Draft”), which …
On September 13, 2019 FDA issued a final guidance document The Special 510(k) Program (“Guidance”). We blogged about the prior draft guidance here. This Guidance, along with The Abbreviated 510(k) Program, supersedes the 1998 guidance document The New 510(k) Paradigm – Alternate Approaches to Demonstrating …
FDA recently finalized the guidance document, Postmarketing Safety Reporting for Combination Products (“PMSR Guidance”). The PMSR Guidance addresses compliance with the final rule on postmarketing safety reporting (PMSR) requirements, 21 C.F.R. Part 4, Subpart B (“PMSR final rule”), for combination products. This is a complicated …
