FDA & Medical Device Status
Classification
PillEnder® is classified by the U.S. Food and Drug Administration (FDA) as a Class I medical device under 21 CFR 880.6430 (Product Code: OHY). The device is intended solely for crushing, grinding, or cutting medication to aid in consumption by individuals who have difficulty swallowing whole pills, including elderly patients, children, and individuals with feeding tubes.
510(k) Exemption
As a Class I device, PillEnder is 510(k) exempt. This means the device does not require premarket notification or FDA clearance before being marketed or sold. This exemption is based on the FDA's determination that Class I devices present low risk to users when used as intended.
Establishment Registration
Although premarket clearance is not required, PillEnder LLC will complete all mandatory establishment registration and device listing with the FDA, as required under 21 CFR Part 807 in the near future. The company also intends to operate in compliance with applicable Good Manufacturing Practices (GMP) as set forth in 21 CFR Part 820, ensuring quality control in design, production, and complaint handling according to US and/or International standards.
Medical Device Reporting
PillEnder LLC adheres to the FDA's Medical Device Reporting (MDR) regulations (21 CFR Part 803). Accordingly, the company is obligated to report to the FDA any incident in which the device may have caused or contributed to a death, serious injury, or malfunction that would likely cause serious harm if recurrent.
Important Limitations and Disclaimers
PillEnder is neither "FDA approved" nor "FDA cleared." These terms apply only to devices that have undergone premarket review, which is not applicable to this product. The device is intended for use exclusively with medications explicitly labeled by a manufacturer, pharmacist, or physician as safe to crush, cut, or grind. Consumers are strongly advised to consult their prescribing physician or a licensed pharmacist before crushing any medication, as certain pills (including extended-release, enteric-coated, or otherwise designed formulations) may become hazardous when crushed.
Regulatory Inquiries
For additional information regarding the regulatory status of PillEnder, please contact us at contact@pillender.com.
