Consumer Medical Devices

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CHPA welcomes FDA’s efforts to modernize and streamline the process for creating and submitting 510(k) premarket notifications and generally supports the approach described in the Draft Guidance. However, CHPA recommends that FDA clarify the following key points when finalizing the Draft Guidance.

Nov 23, 2021

Here are the Federal Register notice summary excerpts that might be of interest to you or others within your organization. Please see notices for complete details.

Nov 18, 2021

The Consumer Healthcare Products Association (CHPA) issued the following statement today from Scott Melville, president and CEO, regarding the nomination of Robert Califf, M.D. as the next U.S. Food and Drug Administration (FDA) commissioner.

Nov 12, 2021

Here are the Federal Register notice summary excerpts that might be of interest to you or others within your organization. Please see notices for complete details.

Nov 10, 2021

Here are the Federal Register notice summary excerpts that might be of interest to you or others within your organization. Please see notices for complete details.

Nov 3, 2021

Here are the Federal Register notice summary excerpts that might be of interest to you or others within your organization. Please see notices for complete details.

Oct 27, 2021

Here are the Federal Register notice summary excerpts that might be of interest to you or others within your organization. Please see notices for complete details.

Oct 20, 2021

FDA issued a long-awaited proposed rule which has the potential to positively affect the lives of millions of consumers by increasing access to affordable over-the-counter (OTC) hearing aids and personal sound amplification products for those who experience hearing loss.

Oct 19, 2021

Here are the Federal Register notice summary excerpts that might be of interest to you or others within your organization. Please see notices for complete details.

Oct 8, 2021

With the World Health Organization, the Global Self-Care Federation has launched a pioneering report for self-care, the Self-Care Readiness Index. The Index reveals factors that influence the uptake of self-care practices in health systems around the world.

Sep 22, 2021

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