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    • FDA Finalizes Guidance on Obtaining Agency Feedback on Combination Products; Highlights Best Practices for Meeting and Communicating with FDADecember 14th, 2020

      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 …

    • FDA Law Alert – December 2020December 4th, 2020

      To close out 2020, Hyman, Phelps & McNamara, P.C. is pleased to present the latest issue of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog.  Please subscribe to the FDA Law Blog to receive contemporaneous posts on regulatory and enforcement …

    • OIG Fires Another Warning Shot at Drug and Device Companies’ In-Person Speaker ProgramsNovember 19th, 2020

      On Monday, the Office of Inspector General (OIG) at the U.S. Department of Health and Human Services (HHS) issued a Special Fraud Alert highlighting “some of the inherent fraud and abuse risks” associated with in-person speaker programs, a widely used channel to educate physicians and …

    • The Potential Life Sciences Implications of the ElectionOctober 30th, 2020

      We have a free Election-eve presentation for you to download!  On October 28th, 2020, Hyman, Phelps & McNamara, P.C. Director Jeffrey K. Shapiro presented a webinar, titled “The Potential Life Sciences Implications of the Election.”  Mr. Shapiro explored the role politics plays at FDA and …

    • The Potential Life Sciences Implications of the ElectionOctober 22nd, 2020

      The medtech industry has significantly changed during the Trump administration’s last four years. FDA processes are streamlined, the medical device excise tax repealed, and the Senate is in the process of confirming a third Supreme Court nominee. The industry also rapidly responded to the unprecedented …

    • FDA (Again) Proposes A Rule to Clarify The “Intended Use” RegulationOctober 19th, 2020

      A determination of “intended use” is fundamental to the U.S. Food and Drug Administration’s (FDA) regulation of drugs and medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).  It is a primary basis for determining if an article is regulated by FDA, and …

    • FDA Launches Digital Health Center of ExcellenceSeptember 25th, 2020

      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 Pre-Cert Program Update – Good Progress but Full Launch Not Yet in SightSeptember 18th, 2020

      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 …

    • FDA Law Alert – September 2020September 10th, 2020

      During these unprecedented times, Hyman, Phelps & McNamara, P.C. is pleased to bring you the next installment of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog.  Please subscribe to the FDA Law Blog to receive contemporaneous posts on regulatory and …

    • Regulation and Utilization of Digital Health in Clinical TrialsSeptember 9th, 2020

      Hyman, Phelps & McNamara, P.C. Director Jeff Shapiro will be moderating “Digital Health Session 1: Bonus Session – Regulation and Utilization of Digital Health in Clinical Trials” as part of the Food and Drug Law Institute’s Digital Health Conference on September 10.  Jeff’s panel will …

    • CDRH Issues Draft Guidance Regarding Patient Reported OutcomesSeptember 8th, 2020

      In recent years, FDA has sought to increase the patient perspective in its regulatory decision making.  One way this is accomplished is through use of patient‑reported outcome (PRO) measures in clinical studies.  PROs can assess concepts that are unobservable to clinicians and are only know …

    • In Support of the New HHS Policy Barring FDA from Premarket Review of LDTsAugust 31st, 2020

      On August 19, the Department of Health and Human Services (HHS) announced that FDA shall no longer conduct premarket review of laboratory developed tests (LDTs) under the Federal Food, Drug, and Cosmetic Act and implementing regulations (FDCA).  The crux of the statement is this:  “the …

    • Mum’s the Word on Hearing AidsAugust 19th, 2020

      Earlier this week, FDA was supposed to issue proposed rules—years in the making—implementing over-the-counter (OTC) hearing aid rules, as required by the Food and Drug Administration Reauthorization Act (FDARA) (read HPM’s summary here).  Under FDARA, FDA is required to issue proposed rules three years from …

    • Is it Lawful to Advertise a Device with an Emergency Use Authorization (EUA) Pending (Prior to Issuance of the EUA)?June 28th, 2020

      In recent months, the Food and Drug Administration (FDA) has issued a record number of Emergency Use Authorizations (EUAs) under Section 564 of the Federal, Food, Drug, and Cosmetic Act (FDCA).  With a large number also pending, this review pathway is becoming almost common for …

    • Tuesdays (and Thursdays) With Regulations.gov BETAJune 11th, 2020

      Anyone who has recently (on Tuesdays and Thursdays at least) tried – and we mean tried – to wander on to www.regulations.gov to do a little FDA docket research has likely been redirected to a new URL: https://outage.regulations.gov/beta-redirect/.  And the first thing you see on …