Comments regarding Citizen Petition from Greenberg Traurig requesting that FDA issue the administrative order for OTC external analgesics, and that FDA confirm and clarify for which specific indications OTC external analgesic drug products in patch/plaster/poultice dosage forms are generally recognized as safe and effective.
CHPA believes that FDA’s issuance of the 2022 Draft Guidance is premature. Instead, FDA’s priority should be on finalizing the 2016 Draft NDI Guidance and clarifying unanswered questions about the scope and applicability of the NDI notification requirement.
CHPA appreciates the opportunity to provide feedback on the notice requesting comments on the Inactive Ingredient Database (IID). Responses to each of the questions listed by FDA in the March 22, 2022 notice are provided.
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devices, CHPA believes that the Agency should: (1) clarify the definition of “consumer health device” used in the draft guidance; and (2) consider expanding the scope of consumer health devices covered by the guidance to not only include class I, but certain class II and unclassified OTC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.
