Since FDA announced in late 2016 that it would not finalize its laboratory developed test (LDT) guidances, it has become clear that any change to the LDT regulatory framework (at least during this administration) would need to come through a statutory change. The first such …
FDA recently hosted a webinar on the final guidance regarding the Breakthrough Devices Program. The Breakthrough Device Program is meant to speed access to new devices that treat or diagnose “life-threatening or irreversibly debilitating diseases or conditions.” See our previous post for a more in-depth …
On January 7, 2019, FDA released new documents related to its Software Pre-Certification (Pre-Cert) Program: Developing a Software Precertification Program: A Working Model (Working Model) Software Precertification Program: Regulatory Framework for Conducting the Pilot Program within Current Authorities (Regulatory Framework) Software Precertification Program: 2019 Test Plan (Test Plan) In …
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, …
On January 9, 2019, the Advanced Medical Technology Association (AdvaMed) announced updates to its “Code of Ethics on Interactions with Health Care Professionals” (Code). The Code was last updated in 2008; the newest updates will become effective on January 1, 2020. The Code includes new sections …
In the midst of the government shutdown and with its accompanying lull in new FDA documents, we thought it would be a good time to update our readers on some guidances that were issued late last year. Two such notable draft guidances were the, “Select …
On December 18, 2018, FDA opened a docket for public comment regarding its intention to shorten the grace period for Global Unique Device Identification Database (GUDID) submissions from thirty days to seven days. The grace period starts when Device Identified (DI) information is first entered …
In two unrelated cases, two U.S. Courts of Appeal affirmed FDC Act-related convictions earlier this week. In United States v. Patino, the Eighth Circuit held that it was not an abuse of discretion to allow the government to introduce, in connection with a 2016 prosecution …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to present its annual report highlighting the leading cases and settlements from 2018 that affect the FDA- and DEA-regulated industries. Each page provides a concise summary of the relevant facts and key takeaways for our clients. We …
The 510(k) program is based on substantial equivalence. A 510(k) submitter wishing to market a new device must establish that it is as safe and effective as a legally marketed device that has already received clearance. The baseline comparison device is known as a “predicate …
Hyman, Phelps & McNamara, P.C. (HPM) is pleased to announce Allyson B. Mullen has become its newest Director. Allyson joined HPM in June 2013. Since that time, her years of service have made significant contributions to the firm and its clients. Prior to joining HPM, Allyson served …
On December 18, 2018, FDA issued a final guidance document on the Breakthrough Devices Program created by the 21st Century Cures Act. The Breakthrough Device Program is meant to speed access to new devices that treat or diagnose “life-threatening or irreversibly debilitating diseases or conditions.” …
For the first time, FDA formally recognized a public database containing information about genes, genetic variants, and their relationship to disease. FDA announced its formal recognition of the genetic variant information in Clinical Genomic Resource (ClinGen) consortium’s ClinGen Expert Curated Human Genetic Data, a database …
On December 18, 2018, FDA published in the Federal Register a new docket entitled, “Notice of Intent to Consider the Appropriate Classification of Hyaluronic Acid Intra-articular Products Intended for the Treatment of Pain in Osteoarthritis of the Knee Based on Scientific Evidence.” This document is quite …
On December 4, 2018, FDA issued a proposed rule that would govern the de novo classification process. After a comment period, it may be re‑issued as a final rule to take affect 90 days after publication. While we agree with FDA’s goal of creating greater …
