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GUIDANCE DOCUMENT

Points to Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance September 1994

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

Many changes are occurring in FDA's regulation of in vitro diagnostic devices as a result of the Safe Medical Devices Act of 1990 (SMDA go), the report of the FDA Committee for Clinical Review, and initiatives of the Office of Device Evaluation (ODE) to raise the quality of scientific review of premarket submissions in a pragmatic manner. The safety of an IVD is inversely proportional to the probability that its use will result in a misdiagnosis of the patient. SMDA 90 broadens the scope of the FDA review of IVDs and authorizes FDA to request clinical data if necessary to ensure that a new IVD is as safe and effective as a legally marketed IVD with the same intended use.


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.