home page is www.fda.gov and has several sites that may be of interest including the following:

The Food Drug and Cosmetic Act is the law that must be followed by all firms who manufacture, fill, and distribute gases classified as drugs, medical devices, or used in food manufacturing or processing, as well as firms manufacturing equipment that deliver or use medical gases. You may view the text of the Food, Drug, and Cosmetic Act as currently amended at: www.fda.gov/opacom/laws/fdcact/fdctoc.htm and then link to various sections of the Act.

The Center for Drug Evaluation and Research (CDER) home page is www.fda.gov/cder where you can sign up for daily or weekly e-mail notice of any updates to the CDER site. This site has numerous links to many other areas of interest. CDER is the center that regulates medical gases classified as drugs -- most medical gas operations.

The CDER Drug (Registration and) Listing Branch home page is www.fda.gov/cder/drls/registration_listing.htm and this page has several links to the laws, regulations, guidance and forms for registration and listing. You may ascertain the status of your firms Drug Site Establishment Registration and Drug listing by typing in you firms name after linking to www.fda.gov/cder/dfars/default.htm for site establishments or www.fda.gov/cder/ndc/database/default.htm for drug listing information.

The CDER Medical Gas home page is www.fda.gov/cder/dmpq/gases.htm. This page provides links to the Compressed Medical Gases Guideline (the last official guidance issued in 1989), the CGMP regulations (21 CFR Parts 210 and 211), and Fresh Air 2000 (a talk paper on current FDA thinking regarding medical gases). This page also provides links to listings of seizure actions taken against, and Warning Letters issued to, medical gas firms since 1993. (Also see the FOI Warning Letters link below)

The Center for Devices and Radiological Health (CDRH) home page is www.fda.gov/cdrh where you can sign up for daily updates to the CDRH site. This site has numerous links to many other areas of interest. CDRH is the center that regulates medical gases classified as devices and all medical gas equipment.

A very helpful CDRH link for device manufacturers is "Device Advice" at www.fda.gov/cdrh/devadvice/11.html, a self-service site that provides information on site registration, devise listing, the Quality System Regulations (device GMPs) as well as several other links.

The Center for Food Safety and Applied Nutrition (CFSAN) home page is www.cfsan.fda.gov with a link to Food Additives at www.cfsan.fda.gov/~lrd/foodadd.html. CFSAN is the center that regulates gases that are used in food processing and packaging.

You may view a copy of the Investigations Operations Manual (IOM) at www.fda.gov/ora/inspect_ref/iom that will allow you to link to Chapter 5 on Establishment Inspections as well as other chapters in the manual

To view the text of actual Warning Letters issued since November of 1996, you may wish to visit the Freedom Of Information (FOI) website at www.fda.gov/foi/Warning.htm that allows you to search Warning Letters, by date, company name, product (e.g., medical oxygen, medical gases, oxygen concentrators, etc.) or issuing district office.

rofessional Organizations offer pamphlets, books, audio tapes, videotapes and also provide public training programs.
Some of these organizations are:

The Compressed Gas Association (CGA) non-member website may be accessed at www.cganet.com. This site provides a link to obtain publications and videotapes that discuss recommended practices for the safe and compliant manufacture, handling, distribution, storage and use of gases including those in the FDA regulated arena. Information on this page is also provided for companies that may wish to become members of the association. The association's seminars and training programs are typically limited to CGA members only. Members also receive electronic copies of publications free of charge.

The Regulatory Affairs Professionals Society (RAPS) website may be accessed at www.raps.org. This homepage offers links to recent regulatory affairs news and events and to the RAPS bookstore and public education programs. Individuals may join RAPS through the membership link. This site is not specific to gases or gas equipment but provides general regulatory information.

The Food Drug Law Institute (FDLI) website may be accessed at www.fdli.org. FDLI sells books, videotapes, audiotapes and periodicals about the laws, regulations, and policies related to drugs, medical devices, and foods. The institute also conducts conference on basic drug, device and food law and specific hot topics related to regulations and policies. A directory of Lawyers and Consultants is available through the Professional Services Directory link on the home page that in-turn provide links to many law firms and consultants home pages. This site is not specific to gases or gas equipment but provides general regulatory information.

The Institute of Validation Technology (IVT) website may be accessed at www.ivthome.com. IVT publishes the Journal of Validation Technology® and the Journal of GXP Compliance®, has other informational publications and products, and sponsors conferences to advance validation technology and practice to help assure compliance with FDA regulations. This site is not specific to gases or gas equipment but provides general validation information.

The American Society for Quality (ASQ) website may be accessed at www.asq.org. ASQ is the leading quality improvement organization in the United States. The Society publishes several periodicals and books on the quality methods, including statistical process control, quality cost measurement and control, total quality management, failure analysis, and zero defects. The organization also conducts seminars on these and other quality related topics. This site is not specific to gases or gas equipment, or to FDA regulated products, but provides general quality information.