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Compliance Corner: Cybersecurity Patches Aren't Recall Events – But A New 510(k) May Be Needed Over Time, Expert Says
Eric Henry with the law firm King & Spalding says that while software cybersecurity patches typically don't rise to the level of a recall, device-makers should still consider the cumulative effect of software changes on products.
Officials in the US FDA's recall divisions advised manufacturers on the best ways to work with the agency during the recalls process, including keeping track of who they're speaking with, making sure all required forms are complete, and not being afraid to use eSubmit.
US FDA Compliance Branch directors Gina Brackett and Melissa Michurski shed light on the agency's use of regulatory meetings. The FDA has been pulling enforcement punches in recent years, relying more on holding the face-to-face meetings than sending warning letters.
Compliance Corner: FDA Investigator Sees These 4 Common Sterilization Problems When Inspecting Facilities
Phil Pontikos, who is also the US agency's national device expert, explains how device-makers can avoid running afoul of the FDA's rules and expectations for sterilization activities.
Compliance Corner: These Are The 6 Top Process Validation Mistakes Made By Firms, According To An FDA Investigator
US FDA investigator Ben Dastoli sees medical device manufacturers making the same process validation mistakes over and over. Here are the top six validation problems he sees.
Compliance Corner: How A Firm Handles Nonconforming Products Can Make Or Break Its FDA Inspection, Investigator Says
US FDA investigator and medical device specialist Thomas Peter says workers at device companies often fail to identify nonconforming products and don't adequately document troubles when they're discovered. Using quality audits is one way to nip this problem in the bud, he explains.
Intertwining design changes and document control is vital for manufacturers – especially for those whose creeping changes to a medical device can turn it into an altogether different product that requires a new 510(k) or PMA from the US FDA. Longtime agency investigator Laureen Geniusz weighs in on what she has seen in the field and offers other nuggets of design change advice.
Two longtime industry experts break down the US FDA’s rules around when an action becomes reportable as a recall to the agency. The bottom line: If you’re changing a device’s safety, then you should probably report it.
Despite being around for years and growing in popularity, there are still manufacturers that have questions about the Medical Device Single Audit Program. MDSAP auditor Brian Ludovico of NSF International answers five of those common questions here.
Compliance Corner: Having A Tight Grip On Suppliers Is Critical For Combination Product Manufacturers
Controlling vendors can be tricky for any manufacturer, but when you're a maker of combo drug-device products, it's doubly important to make sure suppliers are on the up-and-up. Experts from Johnson & Johnson and PAREXEL offer quick tips for keeping a watchful eye on vendors.
Compliance Corner: In Today's 24/7 World, Have Experts On Call For FDA Inspections, Eli Lilly Quality Director Says
Having the right subject matter experts on hand day or night is critical to acing a US FDA facility inspection, Eli Lilly's David Shore advises. In fact, to be sure it always has the right experts available to answer investigator questions, the firm has restructured its organization to include two new roles to support audits: global product stewards and global process stewards.
Compliance Corner: J&J Quality Expert Urges Makers Of Combo Products To Be 'Bilingual' In Device- And Drug-Speak
Speaking the language of both devices and drugs is an important step sometimes missed by makers of combination products. Being "bilingual" is especially important during a facility inspection by US FDA, Johnson & Johnson's Susan Neadle says.
NSF International's Brian Ludovico offers up advice for device-makers facing an audit under the Medical Device Single Audit Program.
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