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# OTC Devices ‘Don’t Need Patient Self-Diagnosis’: CHPA
- URL: https://www.fdaweb.com/otc-devices-dont-need-patient-self-diagnosis-chpa/
- Published: 2023-08-22T12:00:00.000Z
- Updated: 2026-09-14T18:51:52.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155152

Unlike the regulatory requirement for nonprescription drugs that users must be able to self-diagnose, for over-the-counter medical devices FDA should recognize that the safe and effective use may not require that patients can self-diagnose the underlying medical condition. This is one of several recommendations in the Consumer Health Products Association’s (CHPA) [response](https://downloads.regulations.gov/FDA-2023-N-1956-0033/attachment%5F1.pdf?ref=fdaweb.com) to a CDRH request for comment on increasing patient access to at-home use medical technologies.

CHPA also says FDA should continue to recognize the benefits and risks of a device may differ for an OTC indication or home use indication than for a professional use indication, such that the same level of accuracy may not be necessary for OTC or home devices as for professional use devices.

The third CHPA recommendation is that CDRH should prioritize facilitating access to diagnostic tests and other medical technologies that may facilitate access to telehealth and that facilitate access to OTC medications.

Finally, CHPA encourages FDA to develop a consumer-friendly database of medical technologies that have been approved or cleared for OTC use.