National Commission for Medical Devices Act
GPTKB entity
Properties (62)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
legislation
|
| gptkbp:addresses |
emerging technologies
cybersecurity risks healthcare disparities device recalls |
| gptkbp:aimsTo |
patient safety
innovation in medical devices |
| gptkbp:amends |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:effectiveDate |
2022-01-01
|
| gptkbp:enactedBy |
gptkb:United_States_Congress
|
| gptkbp:encourages |
stakeholder engagement
public-private partnerships innovation ecosystems collaboration with academia innovation in diagnostics |
| gptkbp:enhances |
market access for devices
|
| gptkbp:established |
performance metrics
advisory committees data collection systems National_Commission_for_Medical_Devices |
| gptkbp:facilitates |
data sharing
public access to information interagency collaboration technology transfer regulatory science advancements |
| https://www.w3.org/2000/01/rdf-schema#label |
National Commission for Medical Devices Act
|
| gptkbp:improves |
regulatory clarity
|
| gptkbp:includes |
provisions for post-market surveillance
|
| gptkbp:mandates |
supply chain transparency
conflict of interest disclosures reporting of adverse events training for regulators data integrity standards |
| gptkbp:oversees |
medical device approval process
|
| gptkbp:promotes |
public health
patient engagement health equity patient safety culture patient education. |
| gptkbp:provides |
safety standards
public comment periods international cooperation efficacy standards user fees for device applications |
| gptkbp:regulates |
medical devices
|
| gptkbp:requires |
annual reports
clinical trials environmental assessments risk assessment labeling requirements transparency in decision-making ethical standards in research safety evaluations |
| gptkbp:signature |
gptkb:President_of_the_United_States
|
| gptkbp:supports |
research and development
sustainable practices workforce development global health initiatives health technology assessment real-world evidence patient-centered outcomes research clinical trial diversity |