Medical Device “Silent Recalls” CDRH Is on the Lookout Are You Prepared?
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If there’s a problem with a device, where do you draw the line between a routine servicing issue and a “risk to health” you must report to CDRH?
With the FDA cracking down on so-called silent recalls, making the wrong decision can lead straight to 483s, warning letters and even product seizures.
In fact, CDRH Compliance Director Tim Ulatowski warns devicemakers that something as simple as sending out a patch to fix a software glitch can be viewed as a reportable event.
21 CFR Part 806 may be clearly stated — but if your medical device develops a problem, you’d better know how to determine if it’s a “risk to health” to avoid an already costly issue from escalating into a regulatory nightmare.
Head off 483s, warning letters and product seizures
Nearly every devicemaker eventually encounters a serious product problem — and FDA inspectors will be on the lookout for “silent recalls” as never before.
But listen to this 90-minute audio CD/Transcript with quality and compliance expert Michael Patrick Barileand you can stay proactive, making good decisions as device problems arise and preparing effectively for inspections.
Order now for your entire team to get clear guidance on every aspect of 21 CFR Part 806 compliance, including:
- What events must be reported, who is the responsible party and what deadlines apply
- A step-by-step walkthrough of the FDA’s Health Hazard Evaluation form used to classify a recall
- Recordkeeping requirements that apply even if an event isn’t reportable
- 13 items that must be included with your removal or correction report
- Four crucial steps to take before the inspection, including how to produce a single file containing all the information the inspector will want
- Six keys to managing an inspection
- Dos and don’ts for clearing inspection hurdles (such as eliminating any “off- the-record” conversations)
- Real-world case study of how a company’s failure to properly report a device field correction resulted in a warning letter
- Where to send reports in the U.S., EU, Canada and Japan