ClinReg Consulting Services, Inc. specializes in helping medical device and pharmaceutical companies navigate the often-daunting world of premarket clinical and regulatory approval. Below is a list of useful links that can aid during this process:

FDA Program Overview

CBER - Biologics

510(k) Combination Products
Product Codes / CFR Regulation Number Post Approval
IDE FDA Guidances
PMA HHS / CDRH Expertise
HDE Device Searches
Panel Meetings Company Searches
Adverse Events Document Searches
CDER - Drugs Medical Literature Searches

FDA Program Overview

  FDA Program
  ODE Program
  CDRH Website
  Recent Device Approvals

  510(k) Approvals
  510(k) Guidance
  510(k) Program - Overview
  510(k) Content
  510(k) Submission Process
  510(k) New Paradigm
  510(k) De Novo
  513(g) Submission
Product Codes / CFR Regulation Number

  Product Codes
  21 CFR Regulation Number


  Suggested Format for IDE Progress Report
  Changes or Modifications During Clinical Investigation
  Biocompatibility Table

  PMA Approvals
  PMA Supplement Decision Making Process
  PMA Supplement Device Advice
  Device Labeling Guidance (March 1991)
  PMA Manual

  Orphan Product Designation
Panel Meetings

  Panel Meetings
  CDRH 2000 Meeting Documents
  CDRH 2002 Meeting Documents
  FDA Advisory Committees
Adverse Events

  MDR Database
  Adverse Event Reporting System (AERS)
CDER - Drugs

  Catalog of FDA Approved Drug Products
  CDER New and Generic Drug Approvals: 1998-2004
  Orange Book Home Page
CBER - Biologics

  BLA Approvals
Combination Products

  Public Workshop - Combo Products
Post Approval

  Warning Letters
  Postmarket Surveillance
FDA Guidances

  CDRH Guidance Documents
  CDER-CBER Guidance Index
HHS / CDRH Expertise

  HHS People Finder
  CDRH Expertise Listing
  Office of Science and Engineering Laboratories (OSEL)
Device Searches - Medical Device Industry Portal
  MD&DI - Medical DeviceLink
Company Searches

Document Searches

  FOI Services
Medical Literature Searches