US Food & Drug Administration


The FDA has vastly improved the guidance and resources now available through its website. Below is a collection of links, reference materials, informational updates and samples related to compliance with the FDA requirements.

Regulations & Standards

 Document Description Comments
Quality System Regulation/
Medical Device Good Manufacturing Practices
The QSR is the result of the FDA’s revision of the cGMP regulation to make the regulation more consistent with the requirements of ISO 9001:1994 and ISO 13485. Firms commonly use their Quality Manual to map their compliance strategy with each QSR provision.
Good Laboratory Practice
for Nonclinical Laboratory Studies
The FDA’s regulations regarding quality system management controls for experimental research (nonclinical).
Pre-Market Notification
Section 510(k)
Sample 510(k) Cleared by Stuart Bush
FDA 510(k) Clearance Letter Sample (Determination of Substantial Equivalence)
Following are samples of a letter from the FDA indicating its determination of Substantial Equivalence (SE) in response to a 510(k) Premarket Notification submission and an FDA search engine results showing an entry from the FDA 510(k) database:
510(k) Database Search and Predicate Device Information
To find information on predicate devices, search the FDA Product Code Classification Database and the FDA 510(k) Database (see below) to obtain any “Summary” statements (see sample Clearance Letter above). Combine this with any competitve information available through tradeshow literature or website searches to make compelling comparisons with respect to the FDA’s Substantial Equivalence criteria.

                                  Search the FDA 510(k) Database:
A clause-by-clause comparison between the FDA QSR and 13485:2003 requirements prepared by Pilgrim Software.
A Q&A prepared by the FDA discussing the differences between the QSR and ISO 9001:2000 requirements.
Risk Management is considered essential for ensuring the safety and reliability of medical devices by both ISO 13485:2007 and the FDA QSR. ISO 14971 is specifically referenced within ISO 13485 and is recognized by the FDA as an acceptable risk management model.

Related Tools & Topics

 Document Description Comments
This is the guidance the FDA provides to its Field and Center staff for the inspections and administrative/enforcement activities related to the QSR, Medical Device Reporting, Medical Device Tracking, Corrections/Removals, and Registration/Listing regulations.
An update on the FDA’s Premarket Notification – 510(k) Third Party Review program providing 2010 statistics on the effectiveness of this program.
A very informative private industry PowerPoint presentation with solid recommendations for preparing a company for FDA inspections – includes advice for preparing procedures and educating employees with appropriate conduct during inspections.
The FDA’s Small Entity Compliance Guide includes guidance, model procedures and sample forms that may be modified by device manufacturers as appropriate to comply with the QSR regulation.
PowerPoint presentation made by the FDA in 2005 discussing approaches for analyzing the risks for medical devices.
Guidance for implementing design controls as required by the FDA Quality System Regulation (QSR).
Learn what issues the FDA is having with other companies by reviewing recently issued Warning Letters.
The Global Harmonization Task Force (GHTF) has assumed the leadership position for international harmonization in the regulation of medical devices. This site provides informative guidance on quality systems, auditing and risk management, among other topics.
Although the document is several years old, and has not been updated, it still provides an interesting overview of the global medical device market with respect to the top producers, consumers, emerging markets and evolving regulatory climate.
A fairly recent (2010) assessment of the medical device industry prepared by the US Department of Congress. It examines the global markets, including the role of the GHTF and upcoming changes to be introduced by the FDA.