Devices

2 New Device Single Audit Program Training Modules Posted

CDRH posted on 4/6 two new training modules for the Medical Device Single Audit Program. The first covers the measurement analysis and improvement process under the MDSAP. The presentation says that the purpose of an organization’s measurement, analysis, and improvement process is to collect and analyze information, identify and investigate existing and potential causes of product and quality problems, and take appropriate and effective corrective or preventive action to prevent recurrence or occurrence.

“It is essential that an organization verify or validate these actions, communicate corrective and preventive action activities to responsible people, provide relevant information for management review, and document these activities,” the module says. “These activities will help the organization deal effectively with existing or potential product and quality problems, prevent their recurrence or occurrence, and prevent or minimize device failures or other quality problems.”

The second new module, the medical device adverse events and advisory notices reporting process for the MDSAP, explains the process, describes the purpose of auditing the process, discusses the expected outcomes from the audit of the process, and explains the audit tasks in terms of the description and related clauses and regulations for each audit task, the list of country-specific requirements and assessment of conformity for each task, and finally indicates the links of the adverse events and advisory notices reporting process to other MDSAP processes.

The two modules are available here, under the Postmarket Activities tab.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome