Guidance for Peak Flow Meters for Over-the-Counter Sale
Over the past few years the Food and Drug Administration (FDA) has required manufacturers of peak flow meters to include the prescription legend in new devices because of the claims made in their labeling. Since the National Institutes of Health (NIH) released a guidance for the treatment of asthma, which recommend patient monitoring with a peak flow meter, there has been an interest in making peak flow meters widely available. The attached Guidance for Labeling of Peak Flow Meters for Over the Counter Sale was developed by the National Heart, Lung, and Blood Institute (NHLBI) of NIH to facilitate the nonprescription use of these devices, and was distributed to the Anesthesiology and Respiratory Therapy Devices Panel of the FDA for their review. The Panel concurred with the NHLBI Guidance, agreed that it was reasonable to distribute these devices OTC if the labeling guidance is fulfilled, and provided some specific suggestions which are incorporated into the Guidance.
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.