Medical Device manufacturers and importers, please make note of the upcoming FDA Adverse Event codes update. Per the FDA eMDR System Enhancements website, the list of FDA Adverse Event codes accepted in F10 and H6 will be updated to harmonize with the IMDRF Adverse Event Reporting Terminologies. This update will affect the Device Problem Codes and Manufacturer Evaluation Codes, which correspond to IMDRF Annexes A through D. Future updates will harmonize all remaining FDA adverse event codes with IMDRF as more annexes are published. IMDRF codes are not currently accepted by eMDR, but the new hierarchies posted on FDA.gov include a one-to-one mapping of IMDRF codes to FDA codes. FDA codes that are being retired during this update will be rejected by eMDR once this update is deployed. The current non-harmonized hierarchies and the future IMDRF-harmonized hierarchies are currently posted at MDR Adverse Event Codes. The scheduled date of this production update is 6 April 2018.
Senior Director for Pharmaceuticals and Medical Devices, Bryan J. Coleman has summarized a new agency guidance on Refuse to Accept (RTA)’s for 510(k) Medical Device applications. In this summary, Bryan discusses FDA’s newly produced checklists enabling submitters to ensure all required data is complete prior to submission. This should better facilitate FDA’s ability to complete a substantive review by assuring all preliminary information is included. EAS offers services with 510(k) submissions including the review of data and assistance with compiling submissions to the process of submitting to FDA. Please contact Bryan at firstname.lastname@example.org
Guidance Document updates on the FDA website:
- Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment
- Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment
- Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 4 Years of Age and Older
- Migraine: Developing Drugs for Acute Treatment
- Regulatory Classification of Pharmaceutical Co-Crystals
- BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment
- Microbiological Data for Systemic Antibacterial Drugs – Development, Analysis, and Presentation
- Qualified Infectious Disease Product Designation Questions and Answers
- Hypertension: Developing Fixed-Dose Combination Drugs for Treatment
- Refuse to Accept Policy for 510(k)s
- Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
Posted in Drug and Device Corner.