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 We blogged about the prior draft guidance here.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 …
On September 9, 2019, FDA issued a final guidance, Acceptance Review for De Novo Classification Requests. The guidance is meant to provide clarity on the Agency’s expectations for information to be submitted in a De Novo request and to ensure predictability and consistency for sponsors. …
Companies challenging FDA in court typically face a steep uphill battle given the long-standing doctrine known as Auer deference, which (in simplified terms) requires courts to defer to FDA’s interpretation of its own regulations if they are ambiguous. The recent Supreme Court ruling in Kisor …
Hyman, Phelps & McNamara, P.C. is pleased to publish this second issue of the FDA Law Alert, a newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and enforcement …
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 …
FDA advisory panel meetings to review pre-market applications (PMAs) are high-stakes events. While FDA is not bound by the vote of the advisory panel, it has been long-accepted that the agency typically follows the recommendation of the panel. Which got us thinking: are conventional wisdom and …
On June 27, Medtronic announced that it was recalling certain MiniMed insulin pumps due to “potential security vulnerabilities.” On the same day, FDA issued a Safety Communication and the Department of Homeland Security issued a Cybersecurity Infrastructure Security Advisory about the same issue. FDA’s Safety Communication …
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 …
