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Compliance Corner

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Compliance Corner: Listen To 'DRUM' Beat When Writing An After-Inspection Response To FDA, Expert Says

Longtime device industry insider Steve Niedelman shares some best practices for drafting an effective response letter to US FDA following an unfavorable facility inspection.

Compliance Corner FDA Quality Control

Medtech Tips: 7 Expert Pointers For A Successful Pre-Market Submission To US FDA

FDAer-turned-consultant Heather Rosecrans offers valuable tips for a successful submission, from avoiding sending a PMA or 510(k) to the agency during the annual holiday season, to requesting a copy of an FDA reviewer's work through a Freedom of Information Act request – and more.

Medtech Tips FDA

Medtech Tips: 'Don't Be A Data Dump' When Submitting New Products For US FDA Review, Pre-Market Expert Says

Heather Rosecrans, former head of the FDA device center's 510(k) review staff, says manufacturers should be careful not to bombard the agency with a mountain of unnecessary information in new product submissions. She also offers advice on what firms should do if they run into problems with a reviewer.

Medtech Tips FDA

Compliance Corner: FDA's Boyd Gives 4 Pointers For Engaging With The Agency Post-Inspection

Sean Boyd – deputy director for regulatory affairs for the Office of Compliance within US FDA's device center – wants device-makers to take a few steps to ensure that problems identified by investigators during an inspection are adequately addressed.

Compliance Corner Compliance

Medtech Tips: Follow This Advice From FDA's Maisel For A Better Pre-Market Experience

Bill Maisel – director of the Office of Device Evaluation within US FDA's Center for Devices and Radiological Health (among other titles) – says there are four things device-makers should do to make sure they succeed during the product-review process.

Medtech Tips FDA

Compliance Corner: Contract Sterilization Can Be The Bane Of Device-Makers. FDA's Device Expert Sees These 6 Issues

US FDA's Phil Pontikos highlights six problem areas related to contract sterilization that agency investigators routinely see when inspecting manufacturing facilities, from aging facilities to troublesome personnel, and more.

Compliance Corner FDA

Compliance Corner: Keep These 5 Supplier Control Tips In Mind, FDA Officials Say

From cautioning against relying too heavily on a vendor's Certificates of Analysis, to advocating for more robust supplier audits, two US FDA investigators and the agency's national device expert offer device-makers advice for keeping vendors in line.

Compliance Corner Quality Control

Compliance Corner: FDA Investigator Lists 7 Common Human Factors Problems, Says Usability Is 'Overlooked'

Longtime agency investigator Laureen Geniusz reveals seven usability issues that agency investigators regularly see when inspecting medical device manufacturing facilities – troubles that could jeopardize patient safety. Her chief concern? "Human factors seems to be overlooked and not fully understood," Geniusz says.

Compliance Corner Safety

Compliance Corner: Suppliers Can Wreak Havoc On Process Validation Outcomes. Here Are 4 Ways To Keep Them In Check

Having a stellar supplier qualification program in place can lessen the variability in a device-maker's validated processes, says industry expert (and former FDAer) Ricki Chase. She notes that using tools such as questionnaires and onsite audits to determine the suitability of vendors, as well as requalifying and monitoring suppliers of components and services, is essential. "Suppliers can affect your validation activities. Suppliers can completely destroy everything you've put a lot of hard work into," Chase says.

Compliance Quality Control

Compliance Corner: When Should Your Firm Revalidate Under Process Validation? An Expert Explains

Conducting process validation activities isn't a one-and-done deal for device-makers; rather, they must revalidate manufacturing processes from time to time, and when necessary. QA/RA expert Mark Durivage highlights an array of situations that could trigger the need for revalidations.

Compliance Quality Control

Compliance Corner: 5 Key Steps To Reassessing Management Reviews At Your Firm

Abbott Laboratories' quality VP, Monica Wilkins, outlines five steps that device-makers should take when reevaluating their management review process to make sure they get the most out of the meetings.

Compliance Quality Control

Compliance Corner: FDA Wants You To Take These 5 Actions After A Facility Inspection

US FDA's Sean Boyd says what happens after an inspection is over is just as important as what happens before and during one. Here he lists five critical post-inspection activities that device-makers should keep in mind.

Compliance Quality Control

Compliance Corner: 20 Things You Should Never Say To An FDA Investigator

Medical device manufacturers might be tempted to defend themselves during a US FDA inspection. But longtime industry insider Steve Niedelman says there are 20 instances in which firms should remain tight-lipped.

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