Useful Links

STC's Consultants...

Contractual basis for the STC's consultant will assist in projects development for Quality Compliance and all aspects of product development. We will assess and support your project and provide remediation support as needed. We specialize in assisting firms that are under Regulatory scrutiny such as Warning Letters and Consent Decrees.

Training is available on a variety of topics such as:

• Auditing (including internal auditing)

• Quality System Compliance/Conformance

• Design Control

• Risk Management

Useful Links and Information

Links:

Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff

CDRH News:

• Federal Register: Controlling the Progression of Myopia: Contact Lenses and Future Medical Devices; Public Workshop

• Consumer Information on: ExAblate 4000 Type 1.0 System - P150038

• Federal Register: Information To Support a Claim of Electromagnetic Compatibility of Electrically-Powered Medical Device; Guidance for Industry and Food and Drug Administration Staff; Availability

• Federal Register: Medical Devices; Neurological Devices; Classification of the Thermal System for Insomnia

• Public Workshop – Controlling the Progression of Myopia: Contact Lenses and Future Medical Devices, September 30, 2016

• Federal Register: Medical Devices; Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures

CDER News:

• Generic Drug User Fee Amendments (GDUFA) Reauthorization Negotiation Sessions (updated)

• Public Notifications:

  • Public Notification: Dream Body Advanced + Acai Weight Loss & Cleanse contains hidden drug ingredients

  • Public Notification: Dream Body Extreme Gold contains hidden drug ingredients

  • Public Notification: Dream Body Original Formula contains hidden drug ingredient

  • Public Notification: Extra Slim Plus Acai Berry Weight Loss Formula contains hidden drug ingredient

  • Public Notification: SBF Bee Pollen contains hidden drug ingredient

• Manual of Policies and Procedures (MAPP) 4655.3 Rev.2 Procedures for CDER Medical Officer Conversion to Career-Conditional (PDF - 113KB)

• Drug Firm Annual Registration Status Download File (updated)

• Drug Firm Annual Registration Status (updated)

• National Drug Code Directory

• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)