Speaking of novelties and regulatory updates, we can certainly assert that the FDA never sleeps!

Agency is always frenetically busy in issuing new guidelines or documents, helping manufactures and regulators to understand how to comply with the US Regulation on devices.

Keeping up is getting harder. Therefore, let’s take a moment to analyze the latest and most significant four updates.


Recently the FDA published fiscal year 2017 fees, starting from October 1st, 2016 until September 30, 2017. Unexpectedly, we can notice a taxes reduction relating to different practices. For example, the 510(k) fee is $2.345, while on 2016 it was $2.614; the Establishment registration fee is $3.382 against $3.845 in 2016.


After a prolonged silence since the guideline issuance, the FDA finally stated on July 29t that “General Wellness products” are exempt from Medical Devices Regulation . The new “General Wellness: Policy for Low Risk Devices” guideline has been published and it clarifies that FDA is not going to revise, neither approve, low-risk devices for general well-being, such as wearable monitors for physical activity or sleep tracing systems, and will therefore no longer require manufacturers of such product types to comply with medical device Regulation pre-market and post-market requirements.


There are other changes in the air to manage modifications following the Marketing Clearance – 510(k). In particular, the FDA has recently introduced two new guideline drafts, and one of them is entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device”, that is a revision of the previous one and relates to changes to already approved Medical Devices which require a new FDA revision and therefore a new 510(k). In particular, the guideline clarifies how the risk analysis can be used to evaluate whether the device modification involves the need of another FDA revision; it also provides further recommendations to prepare rational justifications if it is considered that the modification should not be submitted to the FDA.
The other guideline, however, is new (entitled “Deciding When to Submit a 510(k) for a Software Change to an Existing Device”) and it refers specifically to the changes made on the software, defining more clearly what are the software modification requiring a new 510(k) and which ones can be managed on the Quality system level. (Did you read ““4 steps to manage a SaMD “in terms of quality””?). All taking a critical eye to Cybersecurity.


The deadline for UDI compliance and class II devices registration to GUDID is approaching, and the FDA always issues new updates for labelers and manufactures. In fact, a guideline draft was released and it is called “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)”. The objective is to clarify the correct format and representation of the UDI code as well as its content.

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Silvia Scarpellini
QA/RA Manager