On August 7, 2023, the Food and Drug Administration (FDA) published Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products (the Draft Guidance), which provides much-needed...more
There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary...more
10/11/2022
/ 21st Century Cures Act ,
510(k) RTA ,
Biomedical Advanced Research and Development Authority (BARDA) ,
CDS ,
Coronavirus/COVID-19 ,
Dietary Guidelines ,
Draft Guidance ,
Emergency Use Authorization (EUA) ,
FDA De Novo Clearance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Over The Counter Drugs (OTC) ,
Proposed Rules ,
Public Health ,
Software ,
User Fees ,
Virus Testing
On June 24, 2021, the Food and Drug Administration (FDA) issued the long-awaited Remanufacturing of Medical Devices Draft Guidance (Draft Remanufacturing Guidance), which describes the agency’s current thinking on activities...more
This post is the first in a series of three in which we recap the Food and Drug Administration’s somewhat difficult year, having spent the majority of it without a permanent Commissioner and facing a slew of political and...more
12/5/2019
/ 21st Century Cures Act ,
Clinical Laboratories ,
Digital Health ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
Regulatory Agenda ,
Regulatory Oversight ,
Statutory Authority
To anyone who has been following government enforcement and private litigation trends related to the over-the-counter (OTC) homeopathic drug industry over the past several years, the Food and Drug Administration’s (FDA)...more
10/28/2019
/ Draft Guidance ,
Enforcement Actions ,
Enforcement Guidance ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Over The Counter Drugs (OTC) ,
Over-the-Counter Sales ,
Pharmaceutical Industry ,
Public Comment ,
Regulatory Agenda ,
Regulatory Standards
On September 26, 2019, FDA released a suite of revised digital health guidances, which includes the following:
- Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act...more
10/10/2019
/ 21st Century Cures Act ,
CDS ,
Comment Period ,
Digital Health ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
International Medical Device Regulators Forum (IMDRF) ,
Medical Devices ,
Medical Software ,
Patients ,
Public Comment ,
Regulatory Requirements ,
Software Developers
As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs...more
12/31/2018
/ 21st Century Cures Act ,
510(k) RTA ,
Biosimilars ,
CMMI ,
Comment Period ,
Cybersecurity ,
Digital Health ,
Draft Guidance ,
FDA De Novo Clearance ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Regulatory Agenda ,
Software Developers
On December 10-11, 2018, FDA hosted a public workshop, Medical Device Servicing and Remanufacturing Activities, as part of its effort to develop a draft guidance that will distinguish servicing activities from...more
On October 18, 2018, FDA released a new draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which describes the Agency’s current thinking and recommendations on designing...more
This is the third installment of our year-in-review series covering major developments at FDA. While the previous two installments, pertain to FDA actions on drugs and biologics, this post will address developments related...more
12/27/2017
/ 510(k) RTA ,
CLIA ,
De Novo Standard of Review ,
Digital Health ,
Draft Guidance ,
FDA Approval ,
Federal Pilot Programs ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Software ,
Standard of Review
The summer of 2016 saw a flood of new medical device-related guidance documents coming out of FDA’s Center for Devices and Radiological Health (CDRH). Some of these draft guidance documents, such as those addressing device...more
On October 14, 2016, FDA released draft guidance entitled Software as a Medical Device (SaMD): Clinical Evaluation (the “SaMD Draft Guidance”). The draft guidance was prepared by the SaMD Working Group of the International...more
FDA released two new draft guidances on Monday, August 8 in an attempt to help device manufacturers determine when a modification triggers the obligation to file a new 510(k) under 21 C.F.R. § 807.81(a)(3). The first draft...more