This is a guest blog post by one of our industry collaborators, Nancy Singer, president of Compliance-Alliance. During her career Nancy has served as a litigator for the FDA, AdvaMed’s Special Counsel for FDA compliance and enforcement matters, an industry spokesperson and a trainer to both FDA and industry. Few things in life are predictable. One event, however, is certain. If your firm manufactures medical devices for sale in the United States, the Food and Drug Administration at some time will inspect your company.
An FDA inspection is important. The investigator will evaluate your ability to comply with the regulatory requirements. A negative determination could affect your ability to sell products in the United States. It also could color all of your dealings with the agency as well as your relationship with partner companies and stockholders.
There are numerous publications that regulatory and quality officials should read to prepare for an inspection. This article will cover the ones that I believe are required reading.
The Quality System Regulation and the Preamble The Quality System Regulation became effective on June 1, 1997. The regulation includes requirements for the methods used in, and the facilities and controls used for designing, manufacturing, packaging, labeling, storing, installing, and servicing medical devices for human use. The preamble to the regulation provides FDA's explanation about the rationale behind the provisions and FDA's responses to questions and suggestions from individuals and organizations commenting on the requirements. Click here
QSIT Handbook This document provides guidance to the FDA field staff on the inspectional process that may be used to assess a medical device manufacturer's compliance with the Quality System Regulation and related requirements. The inspectional process is known as the "Quality System Inspection Technique" or "QSIT". Field investigators generally will use this guidance material to help them focus on key elements of a firm's quality system. Click here
Inspection of Medical Device Manufacturers Compliance Program 7382.845 The compliance program provides guidance to FDA field and center staffs for the inspections and administrative/enforcement activities related to the Quality System (QS) regulation (21 CFR Part 820), the Medical Device Reporting (MDR) regulation (21 CFR Part 803), the Medical Device Tracking regulation (21 CFR Part 821), the Corrections and Removals regulation (21 CFR Part 806), and the Registration and Listing regulation (21 CFR Part 807). Click here
Medical Device Quality Systems Manual: A Small Entity Compliance Guide This manual provides sample procedures and forms for complying with the Quality System Regulation. Click here
Investigations Operations Manual The manual is the primary guidance document on FDA inspection policy and procedures for field investigators and inspectors. Click here
CDRH Mailing Addresses and Phone Numbers This link lists key addresses and phone numbers at CDRH Click here
HHS Employee Directory This link allows you to obtain the phone number and email for FDA employees Click here
AdvaMed Points to Consider for Preparing for an FDA inspection under the Design Controls, CAPA, and Management Control Subsystems These documents provide guidance to firms on how to prepare for FDA inspections under the major subsystems. Click here Click here Click here
Section 704 of the Federal Food, Drug, and Cosmetic Act This provision explains the general parameters for an FDA inspection. Click here
The Guide to International Inspections and Travel This guide provides FDA personnel with standard operational, inspectional, and investigational procedures when conducting international inspections. Click here
Inspection Data Base This data base tells which firms have been inspected and the outcome of the inspection. Click here
FDA Warning letters This link provide access to warning letters by company, district, date, subject, response and closeout letters. Click here
FDA Enforcement Story This link provides access to a magazine on the regulatory actions FDA has taken in recent years. Click here