Today’s blog post illustrates how a company’s problems can escalate rapidly from an administrative warning letter to the full weight of the criminal system. The unfortunate subject is ACell, a manufacturer of medical devices derived from porcine urinary bladder material. ACell received a Warning Letter …
In a 6-3 decision, the U.S. Supreme Court reversed and remanded the lower courts’ decision to publicly disclose commercial information that previously had been submitted to the government. Given that FDA-regulated entities often submit to FDA commercial or financial information that those entities regard as …
FDA recently announced new changes it is making to the Medical Device Reporting (MDR) program as part of its ongoing efforts to increase transparency on device performance, and detection of device-related safety concerns. FDA is formally discontinuing the Alternative Summary Reporting (ASR) Program, which permitted certain …
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, and here). In January of this year, FDA released version 1.0 of Developing …
On April 26, 2019, CDRH released the final guidance, Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions (“Final Guidance”). We previously blogged on the draft version (“Draft Guidance”) here. Overall, the Final Guidance is much the same as the Draft …
Last week FDA issued a final guidance, Unique Device Identification: Convenience Kits, which clarifies FDA’s interpretation of a convenience kit for purposes of UDI labeling requirements. We previously blogged on the draft version here. As our readers know, the unique device identification system regulations require …
The 2019 Maryland Legislative Session closed on April 8th with an exciting development related to laboratory testing. As we previously reported (see here), Maryland law currently prohibits directly or indirectly advertising or soliciting for medical laboratories. Two bills were introduced earlier this year to address …
A cutting-edge aspect of digital health is software as a medical device (SaMD) that uses artificial intelligence and machine learning to improve its performance based on real world use and experience. Until earlier this week, FDA has said very little about how to handle the …
The Food and Drug Law Institute (FDLI) is holding a conference devoted to digital health regulatory issues: Medical Devices: FDA Regulation in the Era of Technology and Innovation. Hyman, Phelps & McNamara’s Jeffrey K. Shapiro is the Chair. The conference will be held in South …
FDA recently issued a draft guidance document, Nonbinding Feedback After Certain FDA Inspections of Device Establishments, which outlines the process for obtaining FDA feedback on proposed remedial actions in response to observations issued on a Form 483, the Agency’s Inspectional Observations Form, following an inspection. Background Section …
An Implanted Brain Computer Interface (BCI) device may sound like something out of science fiction, but FDA apparently believes these devices are on their way to becoming a reality. FDA recently released a draft guidance document that provides recommendations on how to gain approval to …
The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 33rd iteration – is scheduled to take place from March 25-27, 2019, at the Park Lane Hotel in New York, NY. The conference is billed as the premier event to provide folks …
You might remember our prior post on FDA’s proposed expansion of the Abbreviated 510(k) Program. FDA recently issued a final guidance on this program with a brand-new name: Safety and Performance Based Pathway. Other than the new moniker, the final guidance does little to change …
Medical devices provide important diagnostic and treatment benefits to patients. Every day, thousands of patients are the beneficiaries of amazing technology that often did not exist even 10 years ago, and certainly not 50 years ago. At the same time, these medical devices can pose risks …
On February 5, 2019, FDA issued the guidance document The Least Burdensome Provisions: Concept and Principles (Final Guidance). This version supersedes the prior version in place since October 2002. FDA published a draft of the guidance (Draft Guidance) in December 2017, which we blogged on …
