News and Views: Fraudulent FDA ‘registered’ products, Reporting misconduct, Data modernization plan, Real World Evidence for regulatory decision making
FDA Registered” or “FDA Certified” Medical Devices are not FDA approved
Misleading website claims of FDA Registered, FDA Certified, FDA Registration Certificate aometimes along with FDA logo
- Manufacturers register annually with the FDA for the production and distribution of medical devices intended for use in the US
- However, entry in the FDA’s registration and listing database does not denote approval, clearance
- Also, FDA does not issue any type of device registration certificates to medical device facilities.
- Firms misleadingly displaying certificates to imply review or approval by FDA are misbranding’ the product and are in violation of the Federal Food, Drug, and Cosmetic Act
- Check for Approved and Cleared Products in the [email protected] Database
Reporting Allegations of Regulatory Misconduct
Allegation of regulatory misconduct is a claim that a medical device manufacturer or individuals marketing medical devices may be doing so in a manner that violates the law
- Make the FDA aware of regulatory concerns it may not learn of otherwise
- Help the FDA identify the potential risks to patients
Examples include: False promotion or advertising of a device, not submitting required safety reports, noncompliant manufacturing practices, failing to register/list product, not meeting import requirements, document falisfication etc.
Submit an allegation through the Allegations of Regulatory Misconduct Form
Data Modernization Action Plan for Putting Data to Work for Public Health
Data Modernization Action Plan (DMAP) to modernize FDA’s technical infrastructure
- Identify and execute high value driver projects for individual centers and for the Agency;
- Develop consistent and repeatable data practices across the Agency; and,
- Create and sustain a strong talent network combining internal strengths with key external partnerships.
DMAP driver projects will contribute to the FDA’s public health responsibilities in the near term while also building critical capabilities for the future.
Leveraging Real World Evidence in Regulatory Submissions of Medical Devices
Real World Evidence (RWE) is the clinical evidence regarding the usage, and benefits and risks, of a medical product derived from the analysis of Real World Data (RWD)
- Guidance on Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices in 2017
- Range of RWE have been leveraged to assess safety and effectiveness of new products as well as existing products for new uses, and the continued performance and safety of marketed products
- 90 publicly available examples of different types of regulatory submissions supported by RWE
Image credit: FDA