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Forensic Regulatory Assessment is Essential for M & A

Don’ Pay for Your Merger or Acquisition Over and Over Again! Mergers and Acquisitions within the medical device community contribute to the vitality of the industry, but far too many companies think only of forensic accounting. The newly merged company has enough to do without contending with the residual product liability and potential FDA consent decrees because no one looked at the documents in the corner! Systemic regulatory negligence is […]

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21 CFR 820 for QSR is a US regulation- not an option

These days we read a lot about the US FDA “incorporating” ISO 13485. The US Food and Drug Administration proposed a rule in early 2022 to harmonize its medical device quality management system (QMS) regulation, 21 CFR Part 820, to the ISO 13485 QMS standard and as a result some companies decided they did not need to worry about the US regulations. Well, it has finally happened, sort of. So, […]

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Watch out! Exception to the Exemption

The US FDA has “re-classified” and “down-classified” and” exempted” HUNDREDS of medical devices through the last few years. It is difficult to keep track! EXEMPTION from filing is NOT the same as “reclassification.” Most Class 1 devices are “exempt” from a 510(k) submission, but many people do not realize that FDA has also “exempted” certain Class 2 devices—no 510(k) necessary prior to market!But this can be quite a tricky proposition […]

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CYBERSECURITY: What you need to know for your submission

Any medical device which includes software that can be “updated” and/or any device that can export data to another system, will need to meet the FDA’s “cybersecurity” requirements henceforth. Sometimes folks try to argue that any software update will only be conducted by authorized personnel and only with company issued flash-drives will likely find that this mitigation is not sufficient. FDA needs released: Cybersecurity in Medical Devices: Quality System […]

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PRE-SUB 510(K)*– Yes or No?

Don’t file a Pre-Sub for a 510(k) when you don’t need one. A Pre-Sub for a 510(k) should not be seen as a way to avoid doing your own homework. A Pre-Sub is not without risk and can be time consuming. The potential benefits of receiving feedback to your plans should clearly offset the risk of getting answers you don’t want. There are easier ways to confirm you are on […]

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