The U.S. Food and Drug Administration (FDA) has issued formal warning letters to two overseas third-party labs for serious violations involving data falsification, poor quality controls, and noncompliance with regulatory standards—raising red flags for medical device manufacturers that outsource premarket testing to overseas labs.
“The FDA has no room for bad actors,” said Commissioner Marty Makary, M.D., M.P.H. “False and shoddy activity jeopardizes patient access, product sponsors, and the device supply chain.”
What Happened?
After detailed inspections, the FDA found both labs—used for U.S. device submissions—violated Good Laboratory Practices (GLP) and failed to ensure test reliability. Read the news releasehere
Key Violations Identified:
Data Integrity Failures: Incomplete, inaccurate, or untraceable test records
Weak Quality Oversight: Lack of QA systems and supervision
Animal Welfare Lapses: Poor documentation and animal tracking in biocompatibility studies
Training Gaps: Unqualified personnel performing critical testing tasks
These issues compromise the credibility of data submitted in FDA filings—posing risks to manufacturers and patients alike.
Implications for Manufacturers
The FDA reminds manufacturers that they remain fully responsible for the integrity of the data they’re submitting. Companies relying on these “bad actors” could face submission rejections or re-testing requirements. To mitigate risk, the FDA urges manufacturers to:
Reevaluate submissions tied to the cited labs
Strengthen due diligence when selecting third-party labs
Ensure traceability of all submitted test results
Use FDA ASCA-accredited laboratories whenever possible
If your compliance testing has gone off track, don’t worry—we’re here to support you. Let us help you bring clarity and direction back to your project in the fastest, most cost-effective way possible. We understand that time is money.
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So, manufacturers, get your cybersecurity capes on. The EU is coming for your gadgets—and it means business.
Brace Yourselves: The EU Is Mandating Cyber Hygiene for Wireless Devices
Starting August 1, 2025, the EU is tightening the screws on anything with an antenna or IP address. If your device transmits via radio and talks to the internet—even once—it now falls under the revised Radio Equipment Directive (RED 2014/53/EU). In short: your hardware just got a cybersecurity to-do list.
Yes, this applies to a wide array of products: routers, wearables, smart toys, baby monitors, fitness trackers, and any IoT thingamajig you’ve designed to be “smart.” Now it also has to be “secure.”
What’s In Scope?
If it’s radio-equipped and internet-connected, it’s in. Think:
Smartphones, tablets, wireless cameras
Routers and modems
Sensors, wearables, home automation gadgets
Basically, anything with Wi-Fi, LTE, Bluetooth, Zigbee, etc.
If it sends packets or listens for them, you should assume RED applies.
The Three Cyber Must-Haves
Here’s what the Directive now explicitly requires at the engineering level:
Devices that facilitate payments or virtual currency? You’re now responsible for:
Secure user authentication (multi-factor, biometrics, hardware tokens, etc.)
Transaction verification layers
Anti-spoofing and tamper resistance
No hardcoded secrets or reused cryptographic keys, please
This especially applies to mobile wallets, NFC payment gadgets, and wearables that act like debit cards.
But Wait—Where Are the Standards?
Here’s the fun part: no harmonized standards yet. That’s right. As of now, there’s no pre-approved checklist to mark as “compliant.”
You’ll likely need a Notified Body to evaluate compliance unless your implementation clearly aligns with best practices from:
ETSI EN 303 645 (IoT security baseline)
IEC 62433-1 (embedded system threat mitigation)
Translation: Just being “secure” won’t cut it unless you can prove it.
Non-Compliant? No CE Mark = No EU Market
If your product doesn’t meet these new cybersecurity requirements, forget about affixing that CE mark. Customs will be scanning for this, and regulators are expected to ramp up enforcement.
No CE = No sales in the EU. Period.
Engineering Teams:
Audit your devices now for radio+internet exposure
Revisit firmware and protocol stack designs with RED compliance in mind
Document your security measures—you’ll need the paperwork
Build with security as a core requirement, not a post-hoc patch
EU’s message to engineers: If you’re connecting it, you’re protecting it.
CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.
Want to discuss your project with us?
You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.
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ECHA assessed the risks and found that Cr(Vi) is the most potent workplace carcinogen. People living near industrial sites are also at risk for lung and intestinal cancer. Cr(Vi) substances in the following use categories will be banned when they meet the defined limits for exposure and emission.
Formulation of mixtures
Electroplating on plastic substrate
Electroplating on metal substrate
Use of primers and slurries
Other surface treatment
Functional additives/process aids
Cr(Vi) substances are used in industries such as electroplating, surface treatment, aviation, and defense. A large number of authorization applications have strained regulators. ECHA is tasked with potentially transferring these substances from the Registration, Evaluation, Authorization, and Restriction of Hazardous Chemicals (REACH) list to the Restrictions List to shift focus from controlled authorizations to bans with limited exemptions.
This restriction could replace current requirements under the REACH. The REACH list now contains 247 hazardous substances and ensures protection for human health and the environment from hazardous chemical substances. Cr(VI) compounds were added to the REACH SVHC list in December 2010.
An 18-month transition period is being proposed for all restricted uses. ECHA can start a restriction procedure when it is concerned that a specific substance poses an unacceptable risk to human health or the environment. ECHA’s Committee for Risk Assessment will give opinions on whether the restriction is appropriate in reducing the risk to human health and the environment. If the European Commission approves, the restriction will be adopted, and the industry, including all manufacturers, importers, distributors, downstream users, and retailers, must comply. This means that instead of requiring prior authorization Cr(Vi) compounds would be banned from use in the EU.
CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.
Want to discuss your project with us?
You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.
Posted inCE marking|Comments Off on Hexavalent Chromium Faces EU Ban Under New Regulatory Shift
Recently, the European Commission updated some of the guidance regarding the EMC, ATEX, and Low Voltage Directives (and others) to include a warning about unregulated certificates.
The warning explains that voluntary certificates issued by certification bodies not designated as notified bodies under EU law are misleadingly presented for products subject to EU harmonization legislation. A notified body is an organization designated with special credentials by one or more countries in the EU to assess the conformity of products before they are placed on the market. In most cases (almost all) you do not need a Notified Body.
These certificates are not recognized as proof of compliance. Only notified bodies can issue EU type-examination certificates for products and only for product types for which they are listed under NANDO (New Approach Notified and Designated Organizations). Harmonized standards demonstrate that products, services, or processes comply with EU legislation.
Some third-party certifications are misleadingly labeled with terms like “certification” or “certificate,” like the certificate example included below. They are labeled with a CE marking but in this context the CE marking is meaningless.
A device cannot carry a CE marking if it does not meet the requirements of the RoHS directive. RoHS is one of the legal directives a product must conform to bear the CE marking.
The guidance on the referenced European Commission sites indicates that the EU is cracking down on these. The certificate below holds no legal weight, every CE marking Directive requires, with no exceptions, an EU declaration of conformity to be available with the product if the product warrants a CE marking. No EU declaration of conformity, no CE marking. There is no half-measure.
Certificates like these can be deceptive. They look legitimate but are invalid as pertains any claim of CE marking compliance and could potentially stop your product in customs or by market surveillance authorities. The European Commission is clear about these documents; these “certificates” are not recognized as proof of compliance.
CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.
Want to discuss your project with us?
You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.
“My machine is industrial machinery, do I have to comply with RoHS for CE marking?” We are frequently asked this question. The answer is – yes, unless you fall into one of the exclusions available from the RoHS Directive 2011/65/EU. We will pull this apart in this following article.
Let’s take it from the top. The RoHS Directive 2011/65/EU is for the Restriction of Hazardous Substances… colloquially known as “RoHS”. Pronounced “Ross” or “ROH-hass”. The RoHS Directive applies to anything with any electric or electronic function.
First, let’s define what is in scope and then we will look at the exclusions. RoHS is applicable per Article 2, 1:
This Directive shall, subject to paragraph 2, apply to EEE falling within the categories set out in Annex I.
See the list from Annex I:
Large household appliances.
Small household appliances.
IT and telecommunications equipment.
Consumer equipment.
Lighting equipment.
Electrical and electronic tools.
Toys, leisure and sports equipment.
Medical devices.
Monitoring and control instruments including industrial monitoring and control instruments.
Automatic dispensers.
Other EEE not covered by any of the categories above.
Then – let’s see what “EEE” means. See the definition in Article 3, (1):
‘electrical and electronic equipment’ or ‘EEE’ means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields and designed for use with a voltage rating not exceeding 1 000 volts for alternating current and 1 500 volts for direct current;
Summary – if your equipment has any electric or electronic function and it matches any of the equipment listed in Annex I… you are in scope and must comply with the RoHS Directive. This means that every single part of your build must meet the substance level restrictions indicated in Annex II (Note: Annex II was updated by Commission Delegated Directive (EU) 2015/863):
‘ANNEX II Restricted substances referred to in Article 4(1) and maximum concentration values tolerated by weight in homogeneous materials Lead (0,1 %) Mercury (0,1 %) Cadmium (0,01 %) Hexavalent chromium (0,1 %) Polybrominated biphenyls (PBB) (0,1 %) Polybrominated diphenyl ethers (PBDE) (0,1 %) Bis(2-ethylhexyl) phthalate (DEHP) (0,1 %) Butyl benzyl phthalate (BBP) (0,1 %) Dibutyl phthalate (DBP) (0,1 %) Diisobutyl phthalate (DIBP) (0,1 %)…’
The machinery above is in scope of RoHS, unless we can fit it into an exclusion. For the purposes of this article, assume it is in scope. What this means for this build is that every single part and every single piece of every part must comply with the substance restrictions identified in Annex II above. This means the blue and orange plastic, the screws, the cutting blade, housing, tool head, and every piece inside the housing (the board and all of its components) must individually comply with the restriction levels for the above ten identified substances.
Next, we will look at the exclusions dealing with large equipment. Depending upon your equipment – you may or may not be able to exclude it as ‘large-scale”. It depends on a few factors, including how large your equipment is and how large the final installation to which it will be fitted is, and how ‘custom’ your build is.
See RoHS 2011/65/EU, Article 2, 4., (c), (d), and (E):
This Directive does not apply to:
(c) equipment which is specifically designed, and is to be installed, as part of another type of equipment that is excluded or does not fall within the scope of this Directive, which can fulfil its function only if it is part of that equipment, and which can be replaced only by the same specifically designed equipment; (d) large-scale stationary industrial tools; (e) large-scale fixed installations;
OK, first let’s key in on (d) and (e) and what they really mean. See the definitions in Article 3, (3) and (4):
3) ‘large-scale stationary industrial tools’ means a large-scale assembly of machines, equipment, and/or components, functioning together for a specific application, permanently installed and de-installed by professionals at a given place, and used and maintained by professionals in an industrial manufacturing facility or research and development facility;
(4) ‘large-scale fixed installation’ means a large-scale combination of several types of apparatus and, where applicable, other devices, which are assembled and installed by professionals, intended to be used permanently in a pre-defined and dedicated location, and de-installed by professionals;
Next we see consider the two above definitions against Article 2, 4., (c) – defined above and summarized as equipment specifically designed for and permanently mounted to an excluded category of equipment… like large-scale stationary industrial tools and large-scale fixed installations. This does not mean that you can exclude your small device if it can be fitted to any large scale equipment. It means it can be excluded if your small device is custom made for a specific application (one machine, meaning… one unit) that is also excluded. If you make a thermostat that can be fitted to different HVAC systems you are unable to use the Article 2, 4., (c) exclusion. But, if you custom design a thermostat for a very large HVAC system that is custom made for a building or factory… and it is only made for that particular installation then, yes, it can be excluded.
But, what about larger equipment? The European Commission published very specific guidance about this in 2012 and it is still the reference material. That guidance is available at the Euorpean Commission’s RoHS page, here.
Download the FAQ at the link. The document you want is on that web page as a direct download link indicated by the green arrow above. The entire document is worth reading but for this article we want to look at the specific guidance in Section 3. Scope – Large-scale Exclusions starting on page 9. Section 3 elaborates on criteria for large-scale exclusions on page 11, see below:
One possible way of introducing a direct size criterion relates to transportation. The following guidance metrics and qualitative criteria can be applied for installations. If the installation exceeds the minimum requirements for one of the following criteria, it can be considered large-scale:
If, when installing or de-installing the installation, it is too large to be moved in an ISO 20 foot container because the total sum of its parts as transported is larger than 5,71m x 2,35m x 2,39m, it can be considered large-scale.
The maximum weight of many road trucks is 44 tonnes. Thus if, when installing or de-installing the installation, it is too heavy to be moved by a 44 tonne road truck, because the total sum of its parts as transported weighs more than the truck’s load capacity, it can be considered large-scale.
If heavy-duty cranes are needed for installation or de-installation, the installation can be considered large-scale.
An installation that does not fit within a normal industrial environment, without the environment needing structural modification, can be considered large-scale. Examples for modifications are modified access areas, strengthened foundations etc.
If an installation has a rated power greater than 375 kW, it can be considered large-scale. This is only an indicative list.
If your equipment can fit in one tractor trailer load then it is in scope. If your equipment can fit in a 20-foot ISO container it also is in scope. See the truck below. Can your device fit in it when it is crated up? You are in scope and must comply if the answer is yes. In fact, just placing a CE marking on your machine is a claim of compliance to RoHS, if it is in scope. There are penalties for non-compliance. In the case of RoHS especially, compliance is much less expensive than the penalties. In almost all RoHS projects at F2 Labs we are able to get through the evaluation with a positive conclusion (compliant EN 63000:2018 report) and without testing.
Finally, see also Q6.3 from the linked RoHS guidance document below:
Q6.3 Does RoHS 2 apply to EEE for professional and industrial use? Yes. RoHS 2, just as RoHS 1, does not distinguish between EEE for consumer use and EEE for professional and industrial use. In some cases however specific exclusions (Article 2(4)) or timelines (Article 4(3), 4(4) and 4(5)) may apply.
Our advice is that if you cannot exclude your equipment per the above, you are in scope.
CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.
You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.
Ah, the thrilling world of electromagnetic compatibility (EMC) testing! If you’ve ever dreamed of spending quality time with spectrum analyzers and line impedance stabilization networks (LISNs), you’re in for a treat. Let’s embark on a whimsical journey through the essentials of pre-compliance testing for your AC-powered gadgets or DC-powered gadgets that get that power from an AC/DC power supply, inspired by the wisdom of seasoned EMC professionals.
Setting the Stage: Your Test Setup
Picture this: your device under test (DUT) is lounging on a non-conductive table, probably contemplating its existence. Nearby, a spectrum analyzer eagerly awaits, ready to unveil the secrets of your device’s emissions. The LISN stands guard, ensuring that the power line impedance behaves itself. And let’s not forget the ground plane—whether it’s a fancy metallic sheet or a humble piece of heavy-duty aluminum foil, it’s there to catch any stray noise currents trying to escape.
The Usual Suspects: Common Mode and Differential Mode Noise
In the EMC detective story, two culprits often emerge: common mode (CM) and differential mode (DM) noise. CM noise is like that uninvited party guest who sneaks out through both the line and neutral wires, while DM noise is the bickering between the two wires themselves. Identifying which one is causing trouble is crucial for applying the right noise suppression tactics.
The Plot Thickens: Filtering Out the Noise
Without any filters, your DUT might be broadcasting its own radio station, much to the dismay of EMC standards. Introducing a filter board can act like a charm school, teaching those unruly emissions some manners. For instance, adding a filter designed for 150 kHz to 30 MHz can reduce noise by an average of 10 dB. But why stop there? Throwing in a pair of 100 µH inductors in series can further discipline those emissions, achieving reductions up to 30 dB. It’s like sending your emissions to a strict boarding school—they’ll come back transformed.
The Grand Finale: Why Bother with Pre-Compliance Testing?
Embarking on pre-compliance testing is like rehearsing before the big performance. It allows you to catch those off-key notes early, saving you from embarrassing failures during the official compliance test. Plus, it saves time and money—two things every engineer loves. So, embrace the process, and may your devices pass with flying colors (or at least within acceptable emission limits).
Remember, EMC testing doesn’t have to be a dry, monotonous task. With a bit of humor and the right approach, you can turn it into an electrifying adventure. Happy testing!
CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.
Would you like us to help you craft a pre-compliance plan for your new product?
You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.
In January, a new chemical was added to the California Proposition 65 list. Vinyl Acetate was found to cause cancer and has been detected in food packaging, building materials, and contaminated air or soil.
Let’s break this down:
Vinyl acetate is found in polymers which are used in glues, paints, and coatings
It is a component of plastics and resins
Vinyl acetate is used in food packaging, product packaging, and acrylic fibers
It is also found in wire, cable compounds, and safety glass
A Proposition 65 warning is only required for parts that can be touched by users and maintenance personnel. If Vinyl acetate is found, for example, in paint on the outside of a product, it can be touched.
At F2 Labs, we research every component of your build that can be touched. We then determine whether a Proposition 65 warning is required, and in most cases, it is. You don’t want to be fined thousands a day for not doing your due diligence.
CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.
Want to discuss your project with us?
You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.
So, you’ve just had the pleasure of hearing from an Authority Having Jurisdiction (AHJ) or an electrical inspector, and their message was something along the lines of: “You’ve failed your inspection!” or “Your equipment needs a ‘UL or CSA Certification!’” Or maybe they dropped the “UL/CSA Certified” or “UL/CSA Labeled” bomb on you. Don’t panic! We’ve got you covered. Whether it’s a UL or CSA sticker, a fancy certification, or just a quick “You’re good to go!” stamp, we’re here to make sure you can flip that switch, fire up the equipment, and move on to the next project without breaking a sweat.
Now, let’s break down what those “UL” and “CSA” terms actually mean. When someone drops “UL or CSA Certification” into a conversation, what they’re really asking is that your equipment undergoes a little makeover to meet those lovely government guidelines for installation and use. The AHJ or inspector isn’t specifically demanding Underwriters Laboratories (UL) or CSA Group (CSA) to do the honors, but they do want your gear to get a golden ticket from an OSHA-approved NRTL (National Recognized Testing Laboratory). That means you can choose from a smorgasbord of labs to get your equipment certified to meet UL and CSA standards. So, no need to get married to just UL or CSA — you’ve got options, my friend!
If your equipment is currently going through a mid-life crisis and has no label (aka the dreaded “unlabeled equipment” status), leaving you stuck in production limbo and unable to hand over your shiny new machine to your customer, fear not! F2 Labs is here to save the day. We’ll whip up a quick quote and send out our skilled engineers faster than you can say “Field Labeled.” We have three handy U.S. locations ready to deploy our Safety Engineers at lightning speed. And, because we’re pros, we’ll gather all the info we need from you beforehand, so we don’t waste time (or your money) with unnecessary second visits.
Bottom line: You handle the work, we’ll handle the certification. Let’s get that gear labeled and let you get back to the important stuff — like counting all the cash you’re going to make now that your equipment is up to code.
CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.
Want to discuss your project with us?
You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.
Almost anything being sold in California may require a Proposition 65 warning. Proposition 65 is a California law titled the Safe Drinking Water and Toxic Enforcement Act. The law was put in place to protect consumers and notify them if the product contains hazardous chemicals.
The Prop 65 list identifies 900+ risk categories, and the manufacturer must identify parts listed for male and female reproductive harm, cancer, and mutagenic (birth defects) risks. Prop 65 is only required for parts that can be touched by users or maintenance personnel.
Prop 65 applies to products sold or distributed in California. It does not matter where the product is manufactured – if it ends up in California, Prop 65 applies. Law firms can and do send staff down aisles at stores and wipe parts of a product that can be touched. This is called a “wipe test.” If they wipe something in the store and it comes up with Prop 65 substances in it, and it has no corresponding warning for the substance detected, they will send it out for testing. The manufacturer can be fined up to thousands daily, per occurrence, until the product has been removed from the market, or a warning label is placed.
Companies must warn users if their products contain any of these 900+ substance risks. If your product does not contain any such substances, there is no need to include a warning, but you must be sure. The warning label must be placed on the product. A warning may be placed on the packaging if the product is too small to carry a label.
F2 Labs can assist with a Prop 65 evaluation and in almost all cases we get through it without testing.
CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.
Want to discuss your project with us?
You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.
The Office of Environmental Health Hazard Assessment published regulatory changes to the short-form warning label requirements in 2025. The changes will affect the short-form label requirements, including limitations on when they can be used, updates to the required language, and strict formatting guidelines.
Because of the stricter requirements, companies must investigate their supply chains to identify whether their products or components contain chemicals listed under Proposition 65.
Previously, short-form warning labels allowed a simplified format with a generic warning statement, “WARNING: Cancer, Developmental Toxicity, Male Reproductive Toxicity, & Female Reproductive Toxicity – www.P65Warnings.ca.gov.” The new short-form warning must include at least one chemical name associated with the risk being disclosed, “WARNING: This product can expose you to Lead, which is known to the State of California to cause Cancer, Developmental Toxicity, Male Reproductive Toxicity, & Female Reproductive Toxicity. For more information, visit www.P65Warnings.ca.gov.”
The new regulations became effective on January 1, 2025. There will be a three-year grace period, which ends on December 31, 2027. Products manufactured before January 1, 2025, may continue using the old warning labels if they meet the previous compliance standards. Businesses must demonstrate that the products were manufactured before January 1, 2025, and the warnings applied followed the prior regulations.
Starting January 1, 2028, full compliance with the new regulations will be mandatory, regardless of the manufacturing date. All products offered in California must display the updated short-form warnings and meet the revised content, format, and visibility standards.
