Submissions

While CHPA supports FDA’s issuance of a final policy regarding GUDID submission requirements for consumer health devices, CHPA believes that the Agency should: (1) clarify the definition of “consumer health device” used in the draft guidance; and (2) consider expanding the scope of consumer health devices covered by the guidance to not only include class I, but certain class II and unclassified OTC devices.

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for creating and submitting 510(k) premarket notifications and generally supports the approach described in the Draft Guidance. However, CHPA recommends that FDA clarify the following key points when finalizing the Draft Guidance.

CHPA’s argues both constitutional precedent and federal rules on class action lawsuits require classes that capture members who actually have a viable claim and potential right to recovery; not classes in which some consumers are even plausibly harmed.

PCPC and CHPA appreciate the opportunity to comment on FDA Notice of Intent to Prepare and Environmental Impact Statement to evaluate environmental effects for marketing certain OTC sunscreen products.

In keeping with the mission of the FDA Center for Drug Evaluation and Research’s Office of Surveillance and Epidemiology Division of Medication Error and Prevention Analysis, this CHPA member feedback is designed to minimize the risk of medication errors due to consumer confusion attributed to an OTC drug product name.

CHPA is writing to request that FDA exercise its enforcement discretion and not take enforcement action against companies choosing to include a warning related to pregnancy on monograph product labels.

The American Cleaning Institute (ACI) and the Consumer Healthcare Products Association (CHPA) request that FDA withdraw its Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).

Supply chain resilience is essential to assure consumer healthcare products Americans depend on remain widely available, including in times of disease outbreaks or global crises.

The breadth of the proposed rule would create a heavy workload on agencies within HHS, diverting attention from more pressing work. CHPA requests an extension of the comment period

Enclosed are comments on the recent notice from the California Office of Environmental Health Hazard Assessment regarding 22 chemicals to be discussed at a meeting of the Developmental and Reproductive Toxicant Identification Committee. These comments address manganese.