FDA Cleared Versus Approved: The Authorization Record Behind a Device Sale

Medical device FDA cleared versus approved describes two different decisions: clearance compares a device with a legally marketed predicate, while premarket approval requires reasonable assurance of safety and effectiveness for its labeled use. Registration and listing supply neither decision. For regulatory, sales and hospital purchasing staff, the gap to examine is between what FDA authorized and what customers were told.

Registration and Listing Do Not Approve a Device

FDA registration identifies an establishment. Device listing identifies products associated with it. Neither establishes that FDA cleared or approved the product, or that the product may legally be marketed.

The distinction reaches the sales pitch. FDA’s rules treat a representation that creates an impression of official approval because of registration as misleading. They also treat representing substantial-equivalence clearance as official approval as misleading. A registration number and a clearance letter do different jobs, and neither can be turned into an approval by the wording on a brochure.

For a purchasing team, the useful record is the decision covering the device it is buying. A company’s name in a database answers less than the decision, indications and labeling for the particular product. The same comparison matters when a sales representative supplies the hospital with a regulatory summary: which document supports the statement, and which use does that document cover?

The FDA Pathway Determines Which Record Matters

The applicable pathway depends on the device’s classification and intended use. A product code helps locate the device type and its premarket requirements. The class describes the controls needed for the device.

Class I devices generally fall under general controls. Class II devices need special controls as well. Class III covers devices for which those controls are insufficient and whose use or risk calls for premarket approval. Many Class I types and some Class II types are exempt from premarket notification. The device type, exemption and actual use belong together in the comparison.

The evidence behind those decisions differs, too. A substantial-equivalence review can call for clinical or scientific data when needed. FDA says it does not typically inspect a facility before granting clearance. Premarket approval also considers manufacturing methods and controls, and an original PMA may involve a preapproval inspection. The submission and manufacturing records give substance to a sales statement about what FDA reviewed.

Device classes and recall classes measure different risks: a Class I device is in the lowest device-risk class, while a Class I recall concerns the most serious recall risk.

This page covers device authorization, not laboratory-developed tests.

A 510(k) Clearance Is a Comparison With a Predicate

Substantial equivalence requires the same intended use as the predicate and either the same technological characteristics or a supported explanation of the differences. When the technology differs, the evidence must show that the device is as safe and effective as a legally marketed device without raising different questions of safety and effectiveness.

The Federal Food, Drug, and Cosmetic Act makes intended use central to that comparison. A similar shape or shared component does not describe the whole test. The submission’s description of the device, its intended use and its technological characteristics gives the comparison its substance.

The predicate may itself have entered through substantial equivalence. It may also be a device marketed before the medical device amendments or one classified through De Novo. The chain can run through earlier clearances. The comparison does not require proof that the predicate itself was independently shown safe and effective.

The submission summary can name the predicate. A submission using a statement instead promises to make safety and effectiveness information available on request.

Recall history belongs in that examination, too. The law bars certain predicates removed at FDA’s initiative or found by a court to be misbranded or adulterated. The reason for the recall and the predicate’s regulatory status matter to that comparison.

A Changed Device Can Outgrow Its Authorization

A major change in intended use requires a new premarket notification. So can a change in design, materials, components or manufacturing that could significantly affect safety or effectiveness. The authorization question follows what changed, even when the product keeps its name.

For an approved device, the PMA holder initially determines whether a change requires a supplement. Changes affecting safety or effectiveness can include new indications, labeling, sterilization, manufacturing facilities, packaging and design. Certain manufacturing changes use a thirty-day notice route. The original approval is the beginning of that history.

Software changes also belong in the comparison. Where a company relies on an FDA-cleared predetermined change control plan for an update, the change must match that plan. An insider may know precisely which configuration was tested and which one reached customers.

From the Promoted Use to the Provider’s Claim

Off-label use means using a device outside its cleared or approved labeling. The comparison is with the particular indication and use, not simply with whether the product has an FDA number.

The law preserves a practitioner’s authority to use a legally marketed device for a patient within a legitimate practitioner-patient relationship. It also preserves restrictions on sale, distribution, labeling and promotion. The physician’s treatment decision, the manufacturer’s intended use and the provider’s payment claim are separate parts of the story.

Acclarent agreed in July 2016 to an $18 million civil settlement over allegations that it marketed a cleared sinus spacer for steroid delivery without authorization for that use. The Justice Department alleged that this marketing and distribution caused providers to submit false claims to Medicare and other federal health care programs.

That allegation followed the product beyond the clearance letter: from the use the manufacturer sold to the claims providers submitted. The company selling the device and the provider billing the program occupied different places in the transaction.

Genzyme supplies a physical-change parallel. In its civil Seprafilm case, the government alleged that the company taught providers to dissolve the product into a slurry for laparoscopic procedures, causing claims for uses that were not reimbursable. The alleged sales instruction changed how the product was prepared and used. The training material belonged beside the authorization and the bill.

An Exemption Claim Needs Its Own Evidence

An asserted exemption can be the central sales representation. The CareFusion and Avalign cases show what happened when a distributor and manufacturer sold instruments under a claimed pre-amendment exception that the manufacturer’s evidence could not support.

CareFusion agreed to a $3.3 million civil settlement in May 2019. It admitted distributing devices without the required FDA approvals or clearances, for which the manufacturer could not demonstrate that the exception applied.

Avalign Technologies and Instrumed International agreed to a $9.5 million civil settlement that September and admitted the conduct described by the government. Instrumed’s own quality and regulatory leadership had identified the problem: the company had not marketed the device before May 28, 1976. Its distributor repeatedly challenged the evidence, and FDA later rejected the claimed status in a warning letter. Instrumed continued selling.

Its own regulatory staff, its distributor and FDA had challenged the same story. The instruments still reached patients. For an insider, those communications explain who understood the missing authorization and how the sales continued.

How Does Reimbursement Work for Medical Devices?

Medicare usually includes an implanted device in its payment for the procedure or hospital stay. FDA marketing authorization, a billing code, Medicare coverage and the payment amount are separate decisions.

The manufacturer may persuade the physician, while the hospital or surgery center buys the product and bills for the procedure. Implantable devices are often physician preference items: the surgeon may strongly influence the brand and device type. In a consignment arrangement, the manufacturer can own the implant on the hospital’s shelf until it is used. The clinical event can therefore trigger the manufacturer’s sale as well as the institutional bill.

Hospital outpatient payment generally packages implantable and insertable devices into payment for the service. Inpatient payment absorbs their cost into the payment for the stay, and surgery centers generally package implanted devices. Defined exceptions include inpatient new technology add-on payments and outpatient transitional pass-through payments for device categories.

A device charge line can appear without a separate payment for the device. Coverage still asks whether the service meets Medicare’s conditions, including the reasonable-and-necessary requirement. An authorization letter cannot supply the answer to that payment question.

For investigational devices, Medicare can cover routine care around a Category A device under the study conditions, but not the device itself. Category B coverage can include the device too. The FDA categorization letter and Medicare study approval answer different parts of the payment question.

AngioDynamics illustrates how the sales message can reach billing. Its 2018 civil settlement included allegations of unauthorized drug-delivery promotion and inaccurate billing advice for LC Bead. The alleged conduct concerned both the use being promoted and how customers were told to obtain payment. Taxpayers were on the other end of that billing advice.

What Evidence Would Help?

The useful evidence connects what FDA authorized, what the company sold and what the provider billed. Regulatory, quality, sales and hospital billing staff may each see a different part of that connection.

A whistleblower complaint against Diopsys alleged that its marketing implied clearance for a function beyond the one covered by the cleared system’s name:

The alleged difference sits inside the product description. That is why the model and function matter alongside the brand. The same complaint alleged that customer worksheets supplied clinical indications, billing codes and expected reimbursement. Those are the connections we examine with someone who knows what customers were shown.

A hospital claim does not identify the implant by its unique device identifier. The bill can show a procedure without supplying the product detail needed to compare it with FDA’s decision. Clinical, inventory and manufacturer records fill that gap.

This is where an insider’s knowledge earns its value. A regulatory employee may know why the indications stopped where they did. A sales employee may know what training went beyond them. A quality employee may know which change or complaint prompted a decision, while the hospital holds the use and billing records. We connect those accounts to the documents and the government payment. A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

When the Sales Pitch Goes Beyond the Authorization

If you know the device, the cleared indication and what customers were actually told, speak with our whistleblower experts about the gap. We work beside you to trace the sales decision into the provider’s claim and build your strongest medical device whistleblower case. We bring in medical device fraud whistleblower lawyers who understand FDA records and healthcare reimbursement, and stay with you through the process.