Notice to Manufacturers of Bone Mineral Densitometers
On September 4, 1997, the Center for Devices and Radiological Health (CDRH) determined that the Norland Model 178 bone densitometer was in commercial distribution, for use as an aid to the physician in determining fracture risk, prior to May 28, l976, the enactment date of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. This means that manufacturers wishing to market a bone desitometer with a similar claim can do so using the Norland Model 178 as a predicate for the claim.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.