Question 1

Can a device switch from PMA to 510(k)?

Accepted Answer

Rarely. A Class III device may be reclassified to Class II through a reclassification petition or FDA-initiated reclassification, after which a 510(k) becomes possible. This is a multi-year regulatory process and does not apply on demand.

Question 2

Is De Novo a form of 510(k) or PMA?

Accepted Answer

Neither. De Novo is a separate pathway for novel low- to moderate-risk devices without a predicate. A granted De Novo creates a new classification and can then serve as a predicate for future 510(k) submissions.

Question 3

Which pathway carries more post-market risk?

Accepted Answer

Both carry ongoing obligations. PMA devices have explicit conditions of approval and post-approval studies. 510(k) devices are subject to standard postmarket requirements (QMS, MDR, UDI, cybersecurity per Section 524B if applicable) and, for software-containing products, change control that can trigger a new 510(k).

Question 4

Is a 510(k) the same as FDA approval?

Accepted Answer

No. A 510(k) results in FDA clearance based on substantial equivalence to a predicate device. FDA approval refers to Premarket Approval (PMA), which is used for high-risk Class III devices and requires clinical evidence of safety and effectiveness.

Question 5

How long does a 510(k) take?

Accepted Answer

The statutory FDA review clock is 90 days, but total time from submission to clearance commonly runs 3 to 9 months once Refuse to Accept review, Additional Information requests, and interactive review are included.

Question 6

What is the difference between a Traditional, Special, and Abbreviated 510(k)?

Accepted Answer

Traditional is the default pathway. Special 510(k) is for modifications to a manufacturer's own cleared device where design controls fully evaluate the change. Abbreviated 510(k) relies on FDA guidance documents, special controls, or recognized consensus standards to streamline review.

Question 7

How much does a 510(k) cost?

Accepted Answer

The main direct cost is the FDA user fee, which is updated annually and reduced for small businesses. Preparation costs (testing, consulting, writing) are typically far larger than the user fee itself.

Question 8

Do I need a 510(k) for software changes?

Accepted Answer

It depends on whether the change could significantly affect safety or effectiveness. FDA's guidance on 510(k) modifications and the separate software modifications guidance provide decision logic; changes that alter indications, add cybersecurity risk, or introduce new algorithms often require a new 510(k).

Question 9

What is the difference between 510(k) and PMA?

Accepted Answer

510(k) results in clearance based on substantial equivalence to a predicate device and is used for most Class II devices. PMA results in approval based on independent evidence of safety and effectiveness (usually clinical trials) and is required for Class III devices without a suitable predicate.

Question 10

How long does PMA review take?

Accepted Answer

The statutory review clock is 180 days, but real total time from submission to approval commonly runs 1 to 3 years including FDA information requests, panel meetings when convened, and facility inspection.

Question 11

What is a PMA Supplement?

Accepted Answer

A PMA Supplement is submitted for changes to an approved PMA device (new indication, design change, manufacturing site change, labeling change). FDA offers several supplement types (Panel-Track, 180-Day, Real-Time, 30-Day Notice, Special) matched to the change type and risk.

Question 12

Are clinical trials always required for PMA?

Accepted Answer

Almost always. FDA expects independent scientific evidence of safety and effectiveness, which typically requires an IDE-authorized clinical investigation. Exceptions are rare and usually rely on substantial prior clinical experience with a legally marketed foreign predicate.

510(k) vs PMA

When to use which

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