FDA Medical Device Classification,
510(k), 513(g), Labeling

Serving South Florida, Missouri, India

Miami • Broward • West Palm Beach • St. Louis  • New Delhi

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Our Services

• Drug & Medical Device Labeling ;
• Dietary supplement labeling, advertising and review;
• FTC Advertising review (FTC False Advertising)
• Medical Device Classification;
• Medical Device Facility Registration
• Medical Device Product Listing
• Premarket Clearance (510(k) to obtain FDA Approval for medical device including Abbreviated 510(k)s & Special 510(k)s);
• GME (Good Manufacturing Practice) audits;
• FDA De Novo Submission;
• Premarket Approval (PMA);
• 513(g) Classification Ruling;
• Compliance with the bi-annual FDA registration requirement for foreign and domestic food facilities imposed by the Food Safety Modernization Act (FSMA), and ISO 13485;

What is a Food, Drug & Cosmetics Law?

The U.S. Food and Drug Administration (FDA), is responsible for protecting and advancing the public health, by ensuring that: foods are safe, unadulterated, and properly labeled; drugs are safe and effective; medical devices have a reasonable assurance of safety and effectiveness; and that cosmetics and electronic product radiation are not harmful.

Guiding drug and device industry

We pride ourselves on providing our clients with meticulous, ethical, and dedicated legal representation. The Firm provides each client with detailed billing that clearly identifies the type and duration of work performed for the client.