FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | FDA Centennial

FDA News

FDA Drafts Regulatory Direction to Industry for Active Ingredients Used in Medical Tests
Agency accepting public comment on guidance

The U.S. Food and Drug Administration (FDA) today issued draft regulatory guidance for the medical device industry on commercially distributed active ingredients of medical tests called Analyte Specific Reagents (ASRs). FDA is providing this information in response to requests from manufacturers to clarify ASR regulations.

ASRs are chemicals used in tests intended for use in the diagnosis of diseases and conditions, and to help guide medical decision-making.  Companies that commercially distribute ASRs must follow FDA requirements for marketing an In Vitro Diagnostic Device.

"ASRs are the building blocks of medical tests," said Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA. "This guidance is intended to clarify how FDA defines ASRs and what the role and responsibilities of ASR manufacturers are so that the tests that are developed using these ingredients are as safe and effective as possible."

In 1997, FDA issued a rule on ASRs, which defined and classified the substances, imposed restrictions on their sale, distribution and use, and established their labeling requirements. 

The draft guidance better clarifies the definition and regulatory rules of these products for ASR manufacturers.  It also provides information on:

• the 1997 ASR rule and its requirements;
• examples of entities that FDA does and does not consider to be ASRs;
• ASR manufacturers' marketing practices; and
• the research and investigational use of ASRs.

A notice has been submitted to the Federal Register (www.fda.gov/OHRMS/DOCKETS/98fr/ch0561.pdf).  The agency is accepting public comment for 90 days from the date of publication in the Federal Register.  Comments may be sent to www.fda.gov/dockets/ecomments.  Written comments may be sent to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852.  Comments must include the docket number (2006D-0336).

The regulation of all medical devices is risk-based, with devices classified into low-risk (class I), moderate-risk (class II) or high-risk (class III) categories.  For some class I, most class II, and all class III devices, FDA review is required before a new medical device can enter the marketplace.  The FDA regulatory program is comprehensive and includes requirements for registration and listing of products, high-quality production using good manufacturing practices and reporting of adverse events once the products reach the marketplace.

For more information, visit www.fda.gov/cdrh/oivd/tests.html.

####

RSS Feed for FDA News Releases [what's this?]

Get free weekly updates about FDA press releases, recalls, speeches, testimony and more.

FDA Newsroom

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility

FDA Website Management Staff