Q: We just had a product recall outside of the United States. What are the implications with FDA — are we required to notify the Agency about a non-U.S. product recall? A: Technically, no. But you definitely should be prepared to answer…
Tag Archive for medical device
Does FDA Specify Environmental Conditions for Computer Systems?
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Q: Are there FDA guidelines or regulatory requirements for maintaining specific environmental conditions for industrial PCs (HMI, SCADA, DAS, etc.) used in manufacturing operations? If yes, what should be the ideal limits? A: Your question comes from a pharmaceutical perspective but applies…
When a Software Vendor Reduces Its Quality Oversight: What Are Your Options?
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Q: We recently audited a prominent Electronic Data Capture (EDC) software vendor. We were discouraged to learn they’ve restructured their QA group such that the QA oversight role is greatly diminished. For example, the vendor no longer schedules annual internal audits…
Product Risk Assessment Basics: Continually Collect Data, Update Documentation Often
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Q: I’ve been assigned to do a product risk assessment on a new device we’re developing. My background is not in risk management, so any advice you can offer would be very much appreciated. I’m especially concerned about how often we…
What are Considered “Work Operations” under FDA’s CAPA Rules?
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Q: 21 CFR Part 820.100(1) says we should establish and maintain CAPA procedures with requirements for “analyzing processes, work operations…” Does “work operations” mean operations of processes? Should we determine criteria and methods to ensure that our “work operations” are effective?…
FDA Rules for Tracking Exchanged Parts: Are You Servicing, Remanufacturing, or Refurbishing?
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Q: Are there any FDA regulations or requirements that cover the tracking and recording of exchanged parts used in equipment such as medical devices? A: The current answer depends on whether you are servicing the device, remanufacturing it, or refurbishing it. If…
Design Validation: More than Just User Testing
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Q: Really, in the final analysis, isn’t design validation just user testing? A: I’ve heard that a lot lately. But it’s not true. The Quality System Regulation (21 CFR Part 820) includes requirements for design controls. The regulation requires design validation…
FDA Outsourcing Rules: Do They Cover More than Contract Manufacturers?
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Q: Question about FDA outsourcing rules: ISO 13485 requires that when an organization chooses to outsource a process that affects product conformity with requirements, the organization must ensure control over such processes. It also says that control of outsourced processes should…
Complaint Investigation: When You Don’t Have to Investigate Every Complaint
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Q: Does every complaint require some kind of complaint investigation? A: Yes, but with some qualifications. For each complaint you receive, you should determine the extent of the problem, its impact (risk) to the user, patient or by-stander, and its validity. Why…
Determining What’s “Production Equivalent” with a New Product Design
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Q: I’m dealing with a design contract house responsible for product design of a medical device. They are responsible for all of the documentation needed for design control, etc. If we produce the first 100 units via the contract house, those units will be…