Public Warning and Notification of Recalls
Recall: Removal of marketed product that considered to be in violation of FDA laws; Agency would initiate legal action. NOT the same as market withdrawal
Recall Determination: FDA assessment FDA that ongoing or completed removal or correction of a marketed violative product constitutes a recall
Recall Classification: I, II, or III, assigned by FDA on basis of the health hazard
- Class I: Could cause serious health problems or death
- Class II: Might cause a temporary health problem
- Class III: Unlikely to cause any adverse health reaction, violate FDA labeling or manufacturing laws
Public Warning: Alert public that product being recalled presents a serious health hazard; for Class I recalls
Public Notification of Recalls: Weekly FDA Enforcement Report
Acceptance of Clinical Data to Support Medical Device Applications and Submissions
FDA regulations on data acceptance from clinical investigations conducted outside US
- Conform with good clinical practices (GCP)
- Applies to clinical data submitted to support IDE, 510(k), De Novo, PMA, PDP, HDE
Conformity with GCP
- Statements regarding conduct of clinical investigations
- Special considerations for in vitro diagnostic (IVD) device investigations using leftover, de-identified biospecimens
Supporting Information, Waivers, Records
Refuse to Accept Policy for 510(k)
Minimum threshold of acceptability and acceptance for substantive review of 510(k)
- Submission is administratively complete, includes information necessary reach determination regarding substantial equivalence
- Same intended use as predicate device
- Same technological characteristics as predicate device – or- different technological characteristics
- Appropriate clinical or scientific data to demonstrate safety and effectiveness
- Does not raise different questions of safety and effectiveness than the predicate
- Pre-Submission Interaction encouraged
Refuse to Accept Principles
- Not based on substantive review of information
- Justification for any alternative approach
- Consideration of device-specific and cross-cutting guidances
Checklist provided
Image credit: FDA