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Reporting of New Model Numbers to Existing Model Families June 1983

Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The regulations enforcing the Radiation Control for Health and Safety Act of 1968 require manufacturers to submit a report on each new or modified model prior to introduction of that model into commerce. Until now, the Division of Compliance has requested that new model numbers be reported in supplements to the Initial or Model Change Report in which the model family was reported.

The above procedure has resulted in the submission of numerous report supplements. In order to reduce the administrative and financial burden on both the manufacturer and the Division, a new reporting procedure will be implemented. Effective July 1, 1983, we are asking manufacturers to submit a single quarterly report covering all new models of previously reported model families which are to be introduced into commerce during the next three month reporting period. In order to consolidate this information on new models, we request that these periodic submissions be submitted as supplements to the most recent Annual Report.

Submit Comments

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.