On May 17 the Senate Health, Education, Labor and Pensions (HELP) Committee released a bipartisan legislative discussion draft of the Food and Drug Administration (FDA) Safety and Landmark Advancements Act (FDASLA), which...more
Last month, the Senate Health, Education, Labor and Pensions (HELP) Committee voted 20 to 2 to advance S. 3799, the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (the “PREVENT Pandemics...more
In vitro diagnostics (IVD) reform re-entered the legislative fray this week. The Verifying Accurate Leading-edge IVCT Development Act of 2021 (the “VALID Act of 2021,” the “VALID Act” or the “Act”) was introduced in both the...more
Key Points
- FDA will publish draft guidance on its Predetermined Change Control Plan in 2021 and host a public workshop on transparency requirements around AI/ML-based devices.
- FDA plans to pilot Real-World Performance...more
While the United States now leads the world with the number of reported cases of COVID-19, the Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) takes major, though perhaps still incomplete, steps...more
4/1/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Financial Stimulus ,
Health Care Providers ,
Hospitals ,
Medical Devices ,
Medical Supplies ,
Medical Testing ,
Over The Counter Drugs (OTC) ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Relief Measures
Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more
1/8/2020
/ Acquisitions ,
Artificial Intelligence ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
CFIUS ,
Department of Health and Human Services (HHS) ,
Digital Health ,
EU ,
Export Controls ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Innovation ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Mergers ,
Office of Foreign Assets Control (OFAC) ,
Patent-Eligible Subject Matter ,
Pharmaceutical Industry ,
Popular ,
Section 101 ,
USPTO
• The FDA recently issued six guidance documents that further clarify the agency’s interpretation of the 21st Century Cures Act’s software exemptions.
• The revised draft guidance on CDS further elaborates on how to make CDS...more
10/8/2019
/ 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 ,
Popular ,
Public Comment ,
Regulatory Requirements ,
Software Developers
• In a recent warning letter, the Food and Drug Administration (FDA) advised a laboratory to seek marketing authorization for its genetic tests that qualified as laboratory developed tests (LDTs)—which have largely benefited...more
5/14/2019
/ Clinical Laboratories ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Genetic Testing ,
Health Care Providers ,
Labeling ,
Laboratory Developed Tests ,
Life Sciences ,
Marketing ,
Medical Devices
• In recent proposed rulemaking, the Centers for Medicare and Medicaid Services (CMS) make several significant recommendations that incentivize innovation and break down patient barriers to accessing cutting-edge medical...more
Recent FDA Recall Highlights & Developments -
• The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff, providing recommendations regarding the...more
4/11/2019
/ Centers for Disease Control and Prevention (CDC) ,
Distributors ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Recalls ,
Manufacturer Liability ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Product Defects ,
Product Recalls
• FDA has released a white paper outlining a potential regulatory framework for software as a medical device (SaMD) that leverages artificial intelligence (AI) or machine learning (ML).
• The white paper distinguishes three...more
Product recalls are critical events for firms that produce food and medical products. The lives and health of patients and consumers can be at stake. Companies risk enforcement action by the Food and Drug Administration...more
• Two new draft guidances aim to conform FDA’s existing digital health-related policies to the software exemptions from the device definition added by Cures, and are largely faithful to those legislative provisions.
• The...more
1/3/2018
/ 21st Century Cures Act ,
Center for Drug Evaluation and Research (CDER) ,
Digital Health ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Device User Fee Program (MDUFA IV) ,
Medical Devices ,
Medical Software ,
Regulatory Requirements ,
Software Developers ,
Technology Sector
A Food and Drug Administration (FDA) inspector has just knocked on your door and announced that he or she will now inspect your facility. What happens before, during and after this inspection, and what should your firm do to...more
9/12/2017
/ Beverage Manufacturers ,
Department of Justice (DOJ) ,
Enforcement Actions ,
FDA Reauthorization Act ,
Food and Drug Administration (FDA) ,
Food Safety ,
FSMA ,
Information Requests ,
Inspections ,
Medical Devices ,
Office of Regulatory Affairs (ORA) ,
Prescription Drugs
The Food and Drug Administration (FDA) has announced implementation of a new “concept of operations” that seeks to improve FDA’s oversight over pharmaceutical manufacturers. The concept of operations complements FDA’s program...more
Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more
8/9/2017
/ Biologics ,
Biosimilars ,
BsUFA ,
Diagnostic Imaging Services ,
Drug Pricing ,
FDA Reauthorization Act ,
FDARA ,
Food and Drug Administration (FDA) ,
GAO ,
GDUFA ,
Generic Drugs ,
Legislative Riders ,
Medical Device User Fee Program (MDUFA IV) ,
Medical Devices ,
National Evaluation System for Health Technology (NEST) ,
Over-the-Counter Sales ,
PDUFA ,
Pediatrics ,
Pending Legislation ,
Prescription Drugs ,
Supply Chain ,
User Fees
Among the flurry of policies the Food and Drug Administration (FDA) released in the waning days of the Obama administration are several documents that seek to clarify the agency’s positions on communications about medical...more
Key Points -
- Although the Cures medical software provisions largely align with FDA's current policies, certain of the Cures exemptions may be broader than those under current agency policy.
- Many clinical...more
Key Points -
- The 21st Century Cures Act (“Cures” or the “Act”) significantly impacts FDA’s review and approval of medical devices, and how medical devices are covered and paid for.
- These new authorities...more
If you read one thing...
- FDA released Draft Guidance outlining steps for medical device manufacturers to ensure cybersecurity of medical devices already on the market; comments are due by April 21, 2016.
-...more
Draft Guidances Address General Wellness Products and Device Accessories -
The U.S. Food and Drug Administration (FDA or “the Agency”) has announced two more key parameters of its regulatory approach to mobile health...more
On October 14, 2014, the International Medical Device Regulators Forum (IMDRF) issued a final version of “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” (“the...more
On July 31, the Food and Drug Administration (FDA or “the Agency”) notified Congress that it intends to issue draft guidance proposing a Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (“Draft...more