Bryant Godfrey on Regulatory Requirements

Department of Health and Human Services Seeks to Revise Rulemaking Policies

On Friday, February 28, 2025, the Department of Health and Human Services (HHS) issued a policy statement announcing changes to rulemaking processes for agencies within HHS. According to the statement, HHS is rescinding a...more

3/10/2025 / Administrative Procedure Act , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Final Rules , Medicaid , Medicare , Regulatory Reform , Regulatory Requirements , Rulemaking Process

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU) Communications

On January 6, 2025, FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” This...more

2/10/2025 / Final Guidance , Final Rules , Food and Drug Administration (FDA) , Health Care Providers , Healthcare , Life Sciences , Medical Devices , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements

Fostering More Access to Medical Devices: FDA’s Efforts to Advance Health Equity

On August 5, 2024, FDA’s Center for Devices and Radiological Health (CDRH) published a discussion paper entitled, “Discussion Paper: Health Equity For Medical Devices” (Discussion Paper), to aid in its efforts to advance...more

8/14/2024 / CDRH , Clinical Evaluations , Discussion Draft , Food and Drug Administration (FDA) , Healthcare , Innovative Technology , Medical Devices , Patients , Regulatory Requirements

In Search of Harmonization: FDA Finalizes Device CGMP Regulation Harmonization with ISO 13485:2016

On February 2, 2024, FDA finalized its nearly two-year-long process to harmonize QS regulations with ISO standards. As we mentioned when FDA proposed the harmonization in 2022, this update represents the first update to the...more

2/8/2024 / CGMP , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , ISOs , Medical Devices , Regulatory Agenda , Regulatory Requirements

OMB Releases Artificial Intelligence Memorandum to Federal Agencies

Following the landmark October 30, 2023 executive order on artificial intelligence (AI), the White House Office of Management and Budget (OMB) issued a draft memorandum to federal agency heads for the use of AI within their...more

11/22/2023 / Artificial Intelligence , Biden Administration , Executive Orders , Government Agencies , Machine Learning , New Guidance , New Legislation , OMB , Regulatory Reform , Regulatory Requirements

FDA Issues Revised Draft Guidance on “Scientific Information on Unapproved Uses Communications”

On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more

10/25/2023 / Draft Guidance , Food and Drug Administration (FDA) , Health Care Providers , Healthcare , Healthcare Reform , Labeling , Medical Devices , Medical Software , Pharmaceutical Industry , Policies and Procedures , Regulatory Requirements , Regulatory Standards

FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply to Laboratory Developed...

FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to...more

10/3/2023 / CDRH , Clinical Laboratory Testing , Comment Period , Food and Drug Administration (FDA) , Healthcare , Manufacturers , Medical Devices , Proposed Rules , Regulatory Requirements

FDA and Prescription Drug Use Related Software – FDA’s Draft PDURS Guidance Answers Years-Old Questions and Introduces New Ones

After remaining silent on the topic for decades, the Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more

9/26/2023 / Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Healthcare Reform , Labeling , Pharmaceutical Industry , Prescription Drugs , Public Comment , Regulatory Requirements , Software

Big Four Health Committee Leaders Release Request for Information on Regulation of Cannabidiol

On July 27, 2023, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone, Jr., (D-NJ), along with Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Bernie...more

8/2/2023 / Cannabis Products , Comment Period , Controlled Substances Act , Food and Drug Administration (FDA) , Labeling , Legislative Agendas , Product Packaging , Proposed Legislation , Regulatory Agenda , Regulatory Requirements

Bryant Godfrey

Foley Hoag LLP

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