Medical Devices FAQs

New FDA Regulations and Fees

 Establishment Registration and Listing Requirements

Click here to learn more about the NEW Requirements

• Medical Device Advice
• Medical Device FAQS
• Third Pary Review of Medical Devices FAQS
• Current List of Accredited Persons
• What is a Medical Device?

Non-Medical Devices FAQs

• FAQ for Manufacturers of Electronic Products that Emit Radiation
• What form do I need to submit to the FDA Imports office to import my product into the U.S.?
• CeSub eSubmitter (CDRH electronic Submissions)
• Cell Phone FAQs
• Cabinet X-Ray Systems (Closed X-Ray Systems)
• Laser Pointers, Laser Light Shows and Displays, and Products that Incorporate Lasers (CD Players, CD-ROMs, DVDs, and Printers)
• Mirowave Ovens
• Televisions and Video Display Monitors
• X-Ray & Particulate Products other than Medical Diagnostic or Cabinet

Food FAQs

• What is the New FDA Stratigic Action Plan?
• What you need to know about Food Registration
• Nonotechnology
• Food Ingredients and Packaging
  Terms
• Food Ingredients and Packaging
• Food, Nutrition, and Cosmetics Questions & Answers
• Imported Cosmetics
• Imported Cosmetics Compliance Program
• What is Prior Notice?
• The Prior Notice Interface System

Drugs FAQs

• New Guidance Documents
• Drug Firm Annual Registration Status
• Guidance Documents
• Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
• Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
• Drug Master Files CBER Processes and Review

CGMP FAQs

• [CGMPs] Current Good Manufacturing Practice (Pharmaceutical CGMPs for the 21st Century)
• Cosmetic Good Manufacturing Practice Guidelines
• Production and Process Controls

HACCP FAQs

Hazard Analysis and Critical Control Point

• What you need to know about HACPP
• How do Implement HACCP
• HACCP Procedures
• Free FDA Seafood HACCP Training Broadcast Via Satellite