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Procedural Letters

TO: Manufacturers of Medical Devices used for In Vitro Fertilization (IVF)and other Assisted Reproduction Procedures

The purpose of this letter is to clarify the regulatory status of medical devices used in in vitro fertilization (IVF) and other assisted reproduction procedures.

Effective October 13, 1998, the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) reclassified many medical devices used for assisted reproduction from Class III into Class II or Class I as stated in the enclosure. As a result of reclassifying these devices into Class I or Class II, their introduction to the market will be through the 510(k) premarket notification review process. Therefore, manufacturers who intend to market devices for assisted reproduction should refer to the reclassification document when preparing and submitting 510(k) premarket notifications for the appropriate devices.

On September 13, 1995, FDA issued a letter to the industry (attached), which advised manufacturers that they may not market devices that are labeled for assisted reproduction without first obtaining premarket clearance. In our 1995 letter, FDA also committed to providing the industry a reasonable discretionary period for understanding and complying with any subsequent regulations that would publish affecting in-vitro fertilization devices. Therefore, based on that commitment and the publication of the October 13, 1998 Federal Register notice, you will be allowed to continue to market any in-vitro fertilization devices that are already in commercial distribution, providing the following requirements are fulfilled:

1. Within 60 days of the date of this letter, manufacturers of devices labeled, promoted, and/or advertised for use in assisted reproduction procedures, must have submitted to FDA a 510(k) Premarket Notification for each device marketed for distribution in the U.S.
2. If they have not already done so, firms are also required to register their establishments and list the products being manufactured and/or distributed in accordance with Sections 510(b) and/or (c) and (j) of the Federal Food, Drug, and Cosmetic Act (Act), respectively. Although not required, foreign firms are encouraged to register with the FDA; however, they are required to list their devices.
3. As required by the Quality System Regulation (Title 21, Code of Federal Regulations, (21 CFR Part 820)) appropriate procedures and controls are expected to be in place to assure the consistent manufacture of quality devices.
4. Manufacturers and/or distributors are required to adhere to all other pertinent FDA regulations, (Title 21, Code of Federal Regulations (21 CFR)), including Medical Device Reporting (MDR) (21 CFR Parts 803. and 804.), labeling requirements (21 CFR Part 801), corrections and removals (21 CFR Part 806), etc.

Firms complying with the provisions outlined above and the reclassification document may continue marketing their devices until FDA makes a determination whether or not their device(s) are substantially equivalent (SE). Those found "SE" may continue to be legally marketed.

Should FDA render a "not substantially equivalent" (NSE) decision to your 510(k) submission, an approved application for Premarket Approval (PMA) will be required before you may continue to legally market your device(s). In those situations, current marketing of your device(s) must stop pending submission and subsequent approval of a PMA.

Should you have any questions regarding the compliance policies discussed in this letter, please contact Sharon Murrain-Ellerbe in our Office of Compliance, at (301) 594-4616.

Any questions regarding 510(k) submissions for these devices should be directed to Elisa Harvey, D.V.M., Ph.D., at (301) 594-1180.

For further assistance we recommend you contact the Division of Small Manufacturers Assistance (DSMA), a major resource set up to assist device manufacturers and to provide information relating to the regulation of medical devices.

Center for Devices and Radiological Health
Office of Communication, Education, and Radiation Programs
Division of Small Manufacturers Assistance (HFZ-220)
5600 Fishers Lane
Rockville, Maryland 20857
(800) 638-2041
(301) 443-6597
Fax: (301) 443-8818

For your information the final rule has been published on our Website at the following address:

Final Rule: http://www.fda.gov/ohrms/dockets/98fr/091098a.pdf

We trust that this will receive your prompt attention. Thank you for your cooperation.

Updated 5/15/2002

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