Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationWelcome 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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The Latest Posts
FDA Breakthrough Devices Program
Program assists needed products with access to US market The U.S. Food and Drug Administration (FDA) has established the Breakthrough Devices Program, a voluntary program that aims to expedite the development, assessment, and review of medical devices that demonstrate...
Approvals for FDA Breakthrough Devices
Innovative Devices for Unmet Needs The Food and Drug Administration (FDA) has made a positive decision on the marketing applications of the following products. What sets them apart? They are innovative devices that qualified and participated in FDA's Breakthough...
FDA Explores Dental Device Safety Concerns
Dental Devices to Treat Sleep Apnea and TMD The FDA is currently evaluating safety concerns related to certain dental devices called fixed (non-removable) palatal expanders, which are used on adults for jaw remodeling or to treat conditions like obstructive sleep...
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?...