For those of you that are struggling to comply with 21 CFR, Part 820.50, you have two options: one, bite the bullet and script a reasonable procedure needed for effective purchasing controls, including supplier management; or two, embark on a ” hegira ” to escape the wrath of FDA.
Everything from unannounced notified body audits to a rescript of the directive into a regulation injected with steroids, changes are lurking on the horizon when it comes to the MDD.
The use of electronic filing will make your lives easier. Considering the initial requirement to report deaths and serious injuries was born in 1984, it is about time industry moved into the 21st century in regards to the reporting of adverse events.
Outsourcing manufacturing operations has been accepted as routine part of the product life-cycle process as device manufacturers are constantly weighing their options: build in-house versus outsourcing. What are some fundamental questions that need to be asked?
Being delinquent in your establishment’s medical device reporting responsibilities is going to elevate FDA’s concern and bring an appropriate response for offending device manufacturers, including a warning letter. This week’s guidance reviews the sins of an offending establishment and discusses some of the salient requirements associated with complying with 21 CFR, Part 803.
Many American-based devices companies are linguistically challenged when it comes to languages other than English, including UK version of English. However, letting your next door neighbor translate marketing material because Spanish is their native tongue is just insane.
When in doubt about determining the correct device classification, it is always best to contact someone that actually has a thorough understanding of the regulations. In fact, you can even contact FDA.
It is acceptable to outsource just about every conceivable activity associated with medical device manufacturing. However, organizations can never outsource their quality and regulatory responsibilities, as failure to recognize and assume ownership and the wrath of our friends from the agency will be swift and painful.
The moral of this week’s guidance is: “Always do the right things!” However, for those of you with a moral compass that may not always point north, the moral of the story is; “Do not get caught!”
There is no such thing as minimum compliance or maximum compliance, there is just compliance.