Regulatory Compliance and Standards
Regulatory content tests the boundary between FDA device regulation and the accreditation standards that bind a hospital.
FDA pathways and post-market duties
Devices are Class I, II or III by risk. Most Class II devices reach market through 510(k) substantial equivalence; Class III through PMA; novel moderate-risk devices through De Novo. Post-market, medical device reporting under 21 CFR 803 covers deaths, serious injuries and malfunctions likely to cause harm: manufacturers report within 30 calendar days, or 5 working days when remedial action is needed to prevent an unreasonable risk of substantial harm. User facilities report deaths to FDA and the manufacturer and serious injuries to the manufacturer. Corrections and removals fall under 21 CFR 806, and recalls are classified I (reasonable probability of serious harm or death), II (temporary or reversible harm) and III (unlikely to cause harm). UDI appears on labels.
Quality systems
21 CFR 820 is being replaced by the QMSR, harmonized with ISO 13485, effective February 2, 2026. Know the direction of travel even if you work hospital-side.
Hospital standards
The Joint Commission EC.02.04.01 covers the medical equipment management plan, EC.02.04.03 inspection and maintenance, EC.02.05.01 utility systems. NFPA 99 and NFPA 101 apply, along with CMS Conditions of Participation and OSHA rules.
Worked example
An infusion pump battery fails mid-infusion with no harm, and eleven similar events appear in a month. If the manufacturer's investigation shows a lot-specific defect and a field correction is issued to prevent risk, the reporting clock is 5 working days, not 30.
Traps
- Confusing recall class with device class.
- Applying manufacturer reporting rules to a user facility.
- Treating accreditation standards as optional because they are not statutes.