CHPA requests an extension to the “Immediately in Effect Guidance for Industry and Food and Drug Administration Staff: FDA Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking,”
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.
We drafted position statements across five key topic areas in digital health. The position statements are aligned to CHPA’s five key pillars of digital health, which have been validated by members.
CHPA applauds the Agency’s efforts to create a regulatory category for OTC hearing aids to improve patient access for hearing aids, and to implement the hearing aid provisions of the FDA Reauthorization Act of 2017 (“FDARA”).
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devices, CHPA believes that the Agency should: (1) clarify the definition of “consumer health device” used in the draft guidance; and (2) consider expanding the scope of consumer health devices covered by the guidance to not only include class I, but certain class II and unclassified OTC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process for creating and submitting 510(k) premarket notifications and generally supports the approach described in the Draft Guidance. However, CHPA recommends that FDA clarify the following key points when finalizing the Draft Guidance.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.
