CHPA supports efforts to harmonize the current Quality System Regulation with international quality management system requirements. However, CHPA recommends that FDA address several points of concern or clarification when finalizing the Proposed Rule.
CHPA supports the withdrawal or repeal of this rule, as it risks misplaced prioritization of focus by agencies within HHS, leads to workload challenges, and exacerbates problems and backlog in the rulemaking process.
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devices, CHPA believes that the Agency should: (1) clarify the definition of “consumer health device” used in the draft guidance; and (2) consider expanding the scope of consumer health devices covered by the guidance to not only include class I, but certain class II and unclassified OTC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process for creating and submitting 510(k) premarket notifications and generally supports the approach described in the Draft Guidance. However, CHPA recommends that FDA clarify the following key points when finalizing the Draft Guidance.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).