Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationFDA and global regulatory affairs, consumer health, and professional development
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Update – Carcinoma Inside Capsule of Breast Implants
Squamous Cell Carcinoma and Various Lymphomas Located in the Capsule around Breast Implants On March 22, the US Food and Drug Administration (FDA) issued an update to its March 8 safety communication regarding reports of squamous cell carcinoma (SCC) and lymphomas in...
Carcinoma and Lymphomas Found Near Breast Implants
Squamous Cell Carcinoma and Various Lymphomas Located in the Capsule around Breast Implants On March 8, the US Food and Drug Administration (FDA) issued a safety communication concerning reports of squamous cell carcinoma (SCC) and various types of lymphomas in the...
A Team-based Approach to an Expedited 510(k)
Getting an expedited 510(k) submission So, you have created a new medical device by following your quality system’s design controls to plan the project, define design inputs, test to verify that outputs meet inputs, and validated your production product. Now what?...
FDA Warning Letter to Olympus Medical Systems
Letter addresses several violations of FDA&C Act On March 15, 2023, the Food and Drug Administration (FDA) issued a Warning Letter to Olympus Medical Systems Corp. The letter addressed several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act)...
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Postmarket Surveillance – from QSR to QMSR
How QSR Postmarket Surveillance Will Evolve Under the QMSR As medical device manufacturers transition from the FDA’s...
Postmarket Surveillance
What is Postmarket Surveillance (PMS)? Postmarket surveillance (PMS) refers to all activities carried out by manufacturers...
Medical Device Labeling
In the world of medical devices, proper labeling isn't just a regulatory requirement, it is a vital component of patient...
QMSR Clause 8 – Measurement Analysis and Improvement
Using Data to Drive Quality, Risk Control, and Continuous Improvement Clause 8 of ISO 13485:2016 defines how organizations...
QMSR Clause 7 – Product Realization
ISO 13485 Clause 7 - Product Realization Clause 7 of ISO 13485, titled Product Realization, outlines the structured...
QMSR Clause 6 – Resource Management
Ensuring the Organization Has the Capability to Deliver Safe and Effective Medical Devices Clause 6 of ISO 13485:2016...
Welcome to Medical Devices and Pharma, a website dedicated to providing timely and relevant medical device and pharma information to the regulated medical device and pharmaceutical industries, and consumers of those products.
Our goal is to provide organized, clearly written information from regulatory affairs and consumer perspectives.
- Key information from the Food and Drug Administration (FDA), the federal regulatory agency responsible for providing oversight over the industries and assuring the safety and efficacy of their products.
- Regulatory services for compliance, market access, and crisis management
- Information about innovation, including new products cleared for use in the U.S. market.
- News stories with topics ranging from product issues to market trends.
Perhaps most importantly, we will strive to maintain vigilance over product issues and their impacts. Check back here for consumer news, product alerts, and current litigation.
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