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Compliance Corner

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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.

Compliance Corner Cybersecurity Recalls

Compliance Corner: FDA Officials Share Tips To Ensure A Smooth Recall

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.

Compliance Corner Recalls

Compliance Corner: 2 FDA Compliance Branch Heads Talk Regulatory Meetings – And What You Can Expect

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

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 FDA

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 FDA

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.

Compliance Corner FDA

Compliance Corner: Design Creep Can Turn Your Model T Into The Batmobile, FDA Investigator Warns

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.

Compliance Corner FDA

Compliance Corner: When Is An Action Exempt From FDA's Recall Reporting Requirements?

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.

Compliance Corner Recalls

Compliance Corner: MDSAP Auditor Answers 5 Frequently Asked Questions

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.

International Compliance Corner

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 Combination Products

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 Enforcement

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.

Compliance Corner Combination Products

Compliance Corner: 8 Handy Tips From An MDSAP Auditor To Help You Ace Your Next Audit

NSF International's Brian Ludovico offers up advice for device-makers facing an audit under the Medical Device Single Audit Program.

Compliance Corner International
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