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

The 510(k) (section 510(k) of the FD&C Act, 21 CFR 807 subpart E) is a premarket notification: FDA issues an order declaring the device substantially equivalent to a legally marketed predicate (21 CFR 807.100). The De Novo request (section 513(f)(2), 21 CFR 860 subpart D) classifies a device of a new type into class I or II when no predicate exists; the granted device can then serve as a predicate. The PMA (section 515, 21 CFR 814) is an application for approval of a class III device, which needs valid scientific evidence of reasonable assurance of safety and effectiveness.

How is a medical device classified in the United States?

Section 513(a) of the FD&C Act defines three classes. Class I: general controls are sufficient. Class II: general controls plus special controls. Class III: general and special controls cannot provide reasonable assurance of safety and effectiveness, and the device either supports or sustains life, is of substantial importance in preventing impairment of health, or presents a potential unreasonable risk. Each generic device type is described in 21 CFR Parts 862 to 892 with its class and any 510(k) exemption.

Does my class I device need a 510(k)?

Most class I device types are exempt, but the exemption has limits written into each classification part (for example 21 CFR 862.9): it only covers devices that keep the existing or reasonably foreseeable characteristics of the generic type. A device with a new intended use or a different fundamental technology still needs a 510(k). Exempt devices remain subject to general controls such as registration, listing, labelling and Medical Device Reporting.

What is a 513(g) request and how much does it cost?

A 513(g) request asks FDA for a written statement of the class of a device and the requirements that apply to it. It is not a marketing authorisation. Section 513(g) gives FDA 60 days to answer. The FY2027 fee (1 October 2026 to 30 September 2027) is 8,596 USD, or 4,298 USD for a qualifying small business (91 FR 48134).

When does a change to a cleared device require a new 510(k)?

21 CFR 807.81(a)(3) requires a new 510(k) for a change that could significantly affect safety or effectiveness (design, material, chemical composition, energy source, manufacturing process) or a major change in intended use. FDA guidance Deciding When to Submit a 510(k) for a Change to an Existing Device (2017) applies this test. Since the PCCP amendments, no 510(k) is needed for a change consistent with a predetermined change control plan cleared under section 515C (807.81(b)(1)(ii)).

Is a PMA-approved device automatically CE marked under the MDR?

No. The two regimes are independent. A PMA approval gives no CE marking, and a notified body certificate under Regulation (EU) 2017/745 is not an FDA authorisation. Test reports and clinical data can be reused where they meet both sets of requirements, but the regulatory file, UDI registration, post-market surveillance and quality system obligations follow separate texts. See our EU-US dual certification guide.

What is an IDE and when is it required?

The IDE (21 CFR Part 812) allows an unapproved device to be used in a clinical investigation. A significant risk device (812.3(m)) needs an IDE approved by FDA plus IRB approval. Significant risk means a potential for serious risk to subjects: an implant, a life-supporting device, a device of substantial importance in diagnosis or treatment, or any other device with that potential. Being invasive is not the test. Non-significant risk studies follow the abbreviated requirements of 812.2(b) under IRB oversight.

What changed with the QMSR on 2 February 2026?

The final rule published on 2 February 2024 (89 FR 7496) replaced most of 21 CFR Part 820 by an incorporation of ISO 13485:2016, with added FDA requirements (820.10 links to UDI, traceability, MDR reporting and corrections; 820.35 records; 820.45 labelling and packaging). It applies from 2 February 2026. FDA states it will not rely on ISO 13485 certificates for its oversight, and management review, internal audit and supplier audit records are no longer exempt from inspection.

FDA 510(k), De Novo and PMA: US medical devices

Hugues Orgitello updated 7 Oct 2026 18 min read

A medical device reaches the US market through one of three premarket routes run by the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration. The 510(k) premarket notification ends with an order finding the device substantially equivalent to a legally marketed predicate. The De Novo request classifies a new type of device into class I or II when there is no predicate. The premarket approval application (PMA) is for class III and needs valid scientific evidence of safety and effectiveness. This page is built from the texts themselves (21 CFR 807, 860, 814, 812 and 820, sections 513, 515, 524B and 737 of the FD&C Act) and from the FDA notices that set the FY2026 and FY2027 user fees, the eSTAR dates, the MDUFA V review goals and the Quality Management System Regulation that applies from 2 February 2026.

Dated changes, 2022 to 2026

Date	Event	Source
29 December 2022	Section 524B (cybersecurity of cyber devices) enacted by section 3305 of Pub. L. 117-328; in effect 90 days later	21 U.S.C. 360n-2
30 March 2023	FDA announces it will generally not refuse to accept a cyber device submission solely on 524B information before 1 October 2023	FDA notice of availability, 30 March 2023
1 October 2023	eSTAR mandatory for 510(k) submissions, unless exempted	FDA final guidance on the 510(k) electronic submission template (notice of 22 September 2022)
2 February 2024	QMSR final rule published, 89 FR 7496	Federal Register
4 December 2024	Final guidance on predetermined change control plans (PCCP) for AI-enabled device software functions announced	Federal Register
29 May 2025	Q-Submission guidance reissued (supersedes the 2 June 2023 version)	FDA guidance
1 October 2025	eSTAR mandatory for De Novo requests, unless exempted	De Novo eSTAR guidance (notice of 23 August 2024)
2 February 2026	QMSR applies: Part 820 incorporates ISO 13485:2016 by reference	89 FR 7496
3 February 2026	Premarket cybersecurity guidance reissued under the QMS title, superseding the 27 June 2025 version	FDA guidance
18 September 2026	Draft guidance on an eSTAR template for PMA applications and PMA supplements; comments due by 17 November 2026	Federal Register
1 October 2026	FY2027 user fees apply (to 30 September 2027)	91 FR 48134

The MDUFA V performance commitments cover fiscal years 2023 through 2027, so FY2027 is the last year of the current agreement.

The three classes (section 513 and 21 CFR 860)

Section 513(a)(1) of the FD&C Act defines the classes by the controls needed to give reasonable assurance of safety and effectiveness, not by a list of risk adjectives.

Class	Statutory test (513(a)(1))	Usual route
I	General controls are sufficient	Mostly 510(k)-exempt, within the limits of the ".9" section of each classification part
II	General controls are insufficient, special controls can provide the assurance	510(k), unless exempt
III	General and special controls cannot provide the assurance, and the device supports or sustains life, is of substantial importance in preventing impairment of health, or presents a potential unreasonable risk of illness or injury	PMA (or 510(k) for the remaining preamendments class III types not yet called for PMA)

General controls come from sections 501, 502, 510, 516, 518, 519 and 520 of the FD&C Act: adulteration and misbranding, registration and listing, banned devices, notification and repair, records and reports (including Medical Device Reporting under 21 CFR 803) and the quality system requirements of Part 820.

Each generic device type has a regulation in 21 CFR Parts 862 to 892 and a product code. The ".9" section of each part (for example 21 CFR 862.9) limits every 510(k) exemption: it only covers devices that keep the existing or reasonably foreseeable characteristics of the generic type, and for in vitro diagnostics, only where misdiagnosis would not be associated with high morbidity or mortality.

A device of a new type that is not substantially equivalent to anything is class III by operation of section 513(f)(1). The De Novo request is the route out of that automatic class III.

The 510(k) pathway

Who must notify, and when

21 CFR 807.81(a) requires a 510(k) at least 90 days before introducing a device into commercial distribution when the device is new to the market, new to that registrant, or about to be significantly changed. Until FDA issues an order declaring the device substantially equivalent, the applicant may not market it (807.100(a)). A cleared device is "cleared", not "approved".

Substantial equivalence (807.100(b))

FDA finds a device substantially equivalent when:

it has the same intended use as the predicate, and
it has the same technological characteristics, or different characteristics where the data show it is as safe and as effective as a legally marketed device and it does not raise different questions of safety and effectiveness.

The predicate is a device marketed before 28 May 1976 (preamendments), a device reclassified into class I or II, or a device already found substantially equivalent, including a device granted through De Novo.

What 807.87 requires in the file

Paragraph	Content
(a)	Device name: trade name and common or classification name
(b)	Establishment registration number, if applicable
(c)	Class under section 513 and panel, or a reasoned statement that it is unclassified
(d)	Action taken to comply with section 514 performance standards
(e)	Proposed labels, labelling and advertisements describing the device, intended use and directions
(f)	Statement of similarities and differences with comparable marketed devices, with supporting data
(g)	For a significantly changed device or a new indication: data showing the consequences on safety and effectiveness were considered
(h)	510(k) summary (807.92) or 510(k) statement (807.93)
(i)	Financial certification or disclosure (Part 54)
(j)	For clinical data: compliance statement (Parts 50, 56, 812), and 812.28 for data from outside the United States
(k)	For preamendments class III types without a PMA call: summary of safety and effectiveness problems
(l)	Statement that the data are truthful and accurate and no material fact was omitted
(m)	Any additional information FDA requests

Bench, biocompatibility, sterilisation, software, EMC and electrical safety testing all sit under (f) and (g) as the data that support the comparison.

Traditional, Special and Abbreviated

These three formats come from FDA guidance, not from Part 807. The Special 510(k) Program guidance (notice of 13 September 2019) covers a change to the manufacturer's own cleared device where the method to evaluate the change is well established. The Abbreviated 510(k) relies on FDA guidance documents, special controls or recognised consensus standards. The Traditional 510(k) is the default.

eSTAR and the review clock

eSTAR has been mandatory for 510(k) submissions since 1 October 2023 and for De Novo requests since 1 October 2025, unless an exemption in the relevant guidance applies. On the FDA eSTAR page, PMA, PMA supplement and Q-Submission use of eSTAR remains voluntary; a draft guidance for a PMA eSTAR template was announced on 18 September 2026.

The MDUFA V commitment letter sets the 510(k) review goals: an acceptance decision within 15 calendar days (an eSTAR that passes technical screening counts as accepted on receipt), a Substantive Interaction within 60 calendar days for 95 % of submissions, and a MDUFA decision within 90 FDA Days for 95 % of submissions. FDA Days exclude the time a submission is on hold waiting for the applicant, so calendar time is longer.

The De Novo pathway (513(f)(2) and 21 CFR 860 subpart D)

The De Novo process was created by section 207 of FDAMA (1997) and amended by section 607 of FDASIA (2012) and section 3101 of the 21st Century Cures Act (2016). The procedural rule, 21 CFR 860 subpart D (sections 860.200 to 860.260), took effect on 3 January 2022.

A requester may file directly, without a prior 510(k), or after a not substantially equivalent decision. FDA may decline a direct request when it identifies a legally marketed device that could serve as a predicate. When FDA grants the request, the order classifies the device type into class I or II with any special controls, the classification is effective on the date of the order, and the device can serve as a predicate for later 510(k)s.

Points from the text that are easy to miss:

Section 513(f)(2)(A)(iii) gives FDA 120 days to classify; the MDUFA V goal is a decision within 150 FDA Days for 70 % of requests, with conditional increases for FY2026 and FY2027 if earlier goals and fee revenue are met.
860.240(c): before granting or declining, FDA may inspect relevant facilities, both for data integrity and for implementation of the QMSR.
860.250: a request is considered withdrawn if the requester does not answer a deficiency within 180 days.
The FY2027 De Novo fee is 30 % of the PMA fee (see the fee table).

The PMA pathway (section 515 and 21 CFR 814)

Timeline in the regulation

814.42: within 45 days of receipt, FDA tells the applicant whether the PMA is filed. The 180-day review period starts at the filing date.
814.44(a): FDA may refer a PMA to an advisory panel on its own initiative and will do so on request of the applicant, unless the application substantially duplicates information a panel has already reviewed.
814.44(c): within 180 days of filing (or a longer agreed period), FDA issues an approval order, an approvable letter, a not approvable letter or an order denying approval.
MDUFA V goal: decision within 180 FDA Days for 90 % of original PMA applications without advisory committee input, 320 FDA Days with it.

When approved, FDA publishes a notice and a summary of the safety and effectiveness data on which approval was based (814.44(d)).

Changes after approval: which submission

The FD&C Act (section 737(4) and (5)) and 21 CFR 814.39 define the change vehicles. FDA charges each one as a percentage of the PMA fee.

Vehicle	Scope in the text	FY2027 fee share
Panel-track supplement	Significant change in design or performance, or a new indication, needing substantial clinical data (737(4)(B))	80 %
180-day supplement	Not panel-track; significant change in components, materials, design, specification, software, colour additives or labelling (737(4)(C))	15 %
Real-time supplement	Minor change (design, software, sterilisation, labelling) reviewed in a meeting granted by FDA (737(4)(D))	7 %
30-day notice	Change to manufacturing procedures or methods affecting safety or effectiveness (737(5), 814.39(f)); distribution may start 30 days after receipt unless FDA objects, otherwise it becomes a 135-day supplement	1.6 %
Special PMA supplement, changes being effected	Changes that enhance safety, placed into effect before approval: labelling that adds or strengthens a warning or safe-use instruction or deletes unsupported indications, and quality control or manufacturing changes that add a specification or test (814.39(d))	No fee in Table 5
Periodic (annual) report	Changes that do not affect safety or effectiveness, or that are consistent with a PCCP approved under section 515C (814.39(b))	Annual fee 3.5 %

21 CFR 814.39(a)(6) lists "changes in the performance or design specifications, circuits, components, ingredients, principle of operation, or physical layout" as changes that need a supplement when they affect safety or effectiveness. That is a PMA rule; it is not the 510(k) trigger.

User fees, FY2026 and FY2027

FDA publishes the fee rates in the Federal Register each summer. FY2027 rates apply to payments received from 1 October 2026 to 30 September 2027.

Submission	Share of PMA fee	FY2026 standard	FY2026 small business	FY2027 standard	FY2027 small business
PMA, PDP, premarket report, BLA	100 %	579,272 USD	144,818 USD	636,732 USD	159,183 USD
Panel-track supplement	80 %	463,418 USD	115,855 USD	509,386 USD	127,347 USD
De Novo request	30 %	173,782 USD	43,446 USD	191,020 USD	47,755 USD
180-day supplement	15 %	86,891 USD	21,723 USD	95,510 USD	23,878 USD
Real-time supplement	7 %	40,549 USD	10,137 USD	44,571 USD	11,143 USD
510(k)	4.5 %	26,067 USD	6,517 USD	28,653 USD	7,163 USD
30-day notice	1.6 %	9,268 USD	4,634 USD	10,188 USD	5,094 USD
513(g) request	1.35 %	7,820 USD	3,910 USD	8,596 USD	4,298 USD
Annual fee, class III periodic report	3.5 %	20,275 USD	5,069 USD	22,286 USD	5,572 USD
Annual establishment registration	Set in statute	11,423 USD	11,423 USD	13,785 USD	13,785 USD

Sources: 90 FR 35895 (FY2026) and 91 FR 48134 (FY2027), Table 5. A business with gross receipts or sales of no more than 100 million USD (affiliates included) may pay the small business rate; at no more than 30 million USD it may also get a waiver of the fee for its first PMA or premarket report. Small business status must be requested at least 60 days before the fee is due. The registration fee has no small business rate.

Review clocks in the texts

Step	Clock	Source
510(k) before marketing	Submit at least 90 days before distribution	21 CFR 807.81(a)
510(k) decision goal	90 FDA Days for 95 %	MDUFA V letter
De Novo classification	120 days in statute; goal 150 FDA Days for 70 %	513(f)(2)(A)(iii), MDUFA V letter
De Novo deficiency response	180 days, otherwise withdrawn	21 CFR 860.250
PMA filing decision	45 days from receipt	21 CFR 814.42
PMA review	180 days from filing; goal 180 FDA Days (320 with panel)	21 CFR 814.44(c), MDUFA V letter
30-day notice	Distribution 30 days after receipt unless FDA objects	21 CFR 814.39(f)
513(g) response	60 days	Section 513(g)
Request for Designation (combination products)	Letter within 60 days of filing, otherwise the sponsor recommendation applies	21 CFR 3.8(b)
Pre-Submission written feedback	70 days, or 5 days before the meeting if sooner	Q-Sub guidance, 29 May 2025

The 513(g) request

Section 513(g) obliges FDA, within 60 days of a written request, to provide a written statement of the classification of the device (if any) and the requirements that apply to it. It is useful for borderline products, for example software at the limit of the device definition. The answer is not a clearance, and the fee applies (8,596 USD standard for FY2027).

The IDE (21 CFR Part 812)

The IDE allows an unapproved device to be shipped and used in a clinical investigation. Part 812 distinguishes:

Significant risk devices (812.3(m)): an implant, a device supporting or sustaining life, a device of substantial importance in diagnosing, curing, mitigating or treating disease, or any device that otherwise presents a potential for serious risk to the health, safety or welfare of a subject. The study needs an FDA-approved IDE and IRB approval.
Non-significant risk devices follow the abbreviated requirements of 812.2(b): IRB approval, informed consent, labelling, monitoring, records and reports, without an IDE application to FDA.

FDA can decide whether a study is significant risk through a Study Risk Determination in the Q-Submission program.

The HDE (21 CFR 814 subpart H)

A Humanitarian Use Device (HUD) is intended for a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year (814.3(n)). The applicant first obtains a HUD designation from the FDA Office of Orphan Products Development (814.102). The HDE application (814.104) must explain why the device would not be available without an HDE, state that no comparable device is available, and explain why the probable benefit outweighs the risk. Effectiveness does not have to be demonstrated as in a PMA.

The Q-Submission program

The guidance reissued on 29 May 2025 (superseding the 2 June 2023 version and the 1998 guidance on PMA Day-100 meetings) lists five main Q-Sub types: Pre-Submission, Submission Issue Request, Study Risk Determination, Informational Meeting and PMA Day 100 Meeting. The program also tracks Agreement and Determination Meetings, Breakthrough Devices Program and Safer Technologies Program interactions, and Accessory Classification Requests. A Pre-Sub with a meeting gets written feedback within 70 days or 5 days before the meeting, whichever is sooner. FDA feedback is not a decision on a future submission.

The QMSR (21 CFR 820, from 2 February 2026)

The final rule of 2 February 2024 (89 FR 7496) rewrote Part 820. It is short:

Section	Content
820.1	Scope; the FD&C Act and specific FDA rules prevail over conflicting ISO 13485 clauses
820.3	Definitions
820.7	Incorporation by reference of ISO 13485:2016 and of clause 3 (terms and definitions) of ISO 9000:2015
820.10	QMS documented to ISO 13485 plus links to UDI (Part 830), tracking (Part 821), MDR reporting (Part 803) and corrections and removals (Part 806)
820.35	Additional content for complaint and servicing records, UDI recorded for each device or batch, marking of confidential records
820.45	Labelling and packaging controls (UDI, expiry, storage and handling checked before release)

In the preamble FDA states that it does not intend to require ISO 13485 certification and will not rely on ISO 13485 certificates for its oversight; MDSAP audit reports, not certificates, remain usable. The former exception in 820.180(c) that kept management review, quality audit and supplier audit reports away from investigators is not carried over.

Cybersecurity: section 524B

Section 524B applies to a premarket submission for a cyber device: a device that includes software validated, installed or authorised by the sponsor, can connect to the internet, and has characteristics that could be vulnerable to cybersecurity threats. The sponsor must:

submit a plan to monitor, identify and address post-market vulnerabilities and exploits, including coordinated vulnerability disclosure,
design, develop and maintain processes giving reasonable assurance that the device and related systems are cybersecure, and provide updates and patches (on a regular cycle for known unacceptable vulnerabilities, as soon as possible for critical ones),
provide a software bill of materials covering commercial, open-source and off-the-shelf components,
meet any further requirements set by regulation.

The current FDA guidance is "Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions", issued on 3 February 2026 to align with the QMSR. Its threat modelling, SBOM and testing expectations are what reviewers apply to 510(k), De Novo and PMA files for cyber devices.

Software, AI and PCCP

Section 515C, added by section 3308 of Pub. L. 117-328 on 29 December 2022, allows FDA to clear or approve a predetermined change control plan with a 510(k), De Novo or PMA. The regulations now reflect it: no new 510(k) is needed for a change consistent with a PCCP cleared under 515C (807.81(b)(1)(ii)), and a PMA change consistent with an approved PCCP goes in the periodic report (814.39(b)). The final guidance for AI-enabled device software functions (December 2024) describes a PCCP as a Description of Modifications, a Modification Protocol and an Impact Assessment.

Combination products

21 CFR Part 3 assigns the lead center by primary mode of action. When it is unclear, the sponsor files a Request for Designation; under 3.8(b) the product jurisdiction officer issues a letter within 60 days of filing, and if not, the sponsor recommendation becomes the designation. A device-led product follows 510(k), De Novo or PMA; a drug-led one follows the drug route at CDER; a biologic-led one follows the BLA route.

Relationship with the EU MDR

Aspect	FDA (US)	MDR (EU)
Legal basis	FD&C Act, 21 CFR	Regulation (EU) 2017/745
Who decides	FDA (CDRH, CBER)	Notified body, except class I devices that are not sterile, have no measuring function and are not reusable surgical instruments
Classes	I, II, III (section 513)	I, IIa, IIb, III (Annex VIII rules)
Route without predicate	De Novo	No equivalent: classification rules apply directly
UDI database	GUDID	EUDAMED (UDI/device registration is one of the four modules mandatory from 28 May 2026)
Quality system	QMSR (ISO 13485:2016 by reference plus FDA additions)	Article 10(9) MDR, usually shown with EN ISO 13485

Test data (biocompatibility, electrical safety, EMC, software, usability) can serve both files when the methods meet both sets of requirements. See our MDR guide, our EU-US dual certification guide and the certification timeline. The CE page covers CE marking in general and the FCC page covers the US radio and EMC rules for the radio part of a connected device.

Claims the texts contradict

Common claim (including on earlier versions of this page)	What the text says
Class III means "devices that support or sustain life"	513(a)(1)(C) has two conditions: general and special controls are insufficient, and the device supports or sustains life, is of substantial importance in preventing impairment of health, or presents a potential unreasonable risk
A new 510(k) is needed whenever a change touches the principles of operation	807.81(a)(3): a change that could significantly affect safety or effectiveness, or a major change in intended use. "Principle of operation" is in the PMA supplement list (814.39(a)(6)). A change within a cleared PCCP needs no 510(k)
A significant risk device is an invasive device	812.3(m) turns on a potential for serious risk (implant, life-supporting, substantial importance in diagnosis or treatment, or otherwise). Invasiveness is not a criterion
510(k) exemptions "never cover devices in contact with a critical site"	No such rule. The ".9" limitation section of each classification part restricts exemptions to devices with existing or reasonably foreseeable characteristics of the type (and, for IVDs, low-consequence misdiagnosis)
21 CFR 814 defines Original, Modular, Panel-Track, 180-Day and Real-Time PMA	Modular PMA is not in Part 814. Panel-track, 180-day and real-time supplements are defined in section 737(4) of the FD&C Act; 814.39 adds the special PMA supplement and the 30-day notice
A 513(g) answer takes a few months	Section 513(g): within 60 days of the request
De Novo files are generally not inspected	860.240(c): FDA may inspect relevant facilities before granting or declining a De Novo, including for QMSR implementation
The Advisory Committee is "frequent" for PMA files	814.44(a): FDA may refer a PMA to a panel and must do so if the applicant asks, unless a panel already reviewed substantially the same information
eSTAR is mandatory for every premarket submission	Mandatory for 510(k) (1 October 2023) and De Novo (1 October 2025); voluntary for PMA, PMA supplements and Q-Subs. The PMA template is at draft guidance stage (18 September 2026)
For an ISO 13485 certified manufacturer, the QMSR transition is "mostly documentary"	FDA will not rely on ISO 13485 certificates, adds 820.10, 820.35 and 820.45, and investigators can now see management review and audit reports that 820.180(c) used to exempt
User fees are "low" for a 510(k)	FY2027 standard fee is 28,653 USD (7,163 USD for a small business), and every establishment pays 13,785 USD a year for registration

Pitfalls that come from the texts

Intended use drift. 807.100(b) starts with "same intended use". Labelling or marketing that widens the indication can turn a 510(k) into a De Novo or PMA question.
Wrong change vehicle. 510(k) devices follow 807.81(a)(3); PMA devices follow 814.39 and section 737. Using one logic for the other produces missed submissions.
Small business status too late. The SBD request must reach FDA at least 60 days before the fee is due.
Cyber device file incomplete. Section 524B makes the vulnerability plan, the update process and the SBOM part of the submission, not optional annexes.
QMS built around a certificate. Under the QMSR, FDA inspects against Part 820 and its added requirements, whatever the certificate says.
Clearance called approval. A 510(k) device is cleared; only PMA (and HDE) devices are approved.

What this page does not cover

Product code research in the FDA Product Classification database, step-by-step eSTAR completion, the content of a software documentation package, and post-market obligations (Part 803 reporting, Part 806 corrections and removals, Part 822 post-market surveillance) are outside the scope of this page.

The glossary lists key terms (510(k), De Novo, PMA, IDE, HDE, PCCP, QMSR) with their definitions and cross-references.

Frequently asked questions

What is the difference between 510(k), De Novo and PMA?: The 510(k) (section 510(k) of the FD&C Act, 21 CFR 807 subpart E) is a premarket notification: FDA issues an order declaring the device substantially equivalent to a legally marketed predicate (21 CFR 807.100). The De Novo request (section 513(f)(2), 21 CFR 860 subpart D) classifies a device of a new type into class I or II when no predicate exists; the granted device can then serve as a predicate. The PMA (section 515, 21 CFR 814) is an application for approval of a class III device, which needs valid scientific evidence of reasonable assurance of safety and effectiveness.
How is a medical device classified in the United States?: Section 513(a) of the FD&C Act defines three classes. Class I: general controls are sufficient. Class II: general controls plus special controls. Class III: general and special controls cannot provide reasonable assurance of safety and effectiveness, and the device either supports or sustains life, is of substantial importance in preventing impairment of health, or presents a potential unreasonable risk. Each generic device type is described in 21 CFR Parts 862 to 892 with its class and any 510(k) exemption.
Does my class I device need a 510(k)?: Most class I device types are exempt, but the exemption has limits written into each classification part (for example 21 CFR 862.9): it only covers devices that keep the existing or reasonably foreseeable characteristics of the generic type. A device with a new intended use or a different fundamental technology still needs a 510(k). Exempt devices remain subject to general controls such as registration, listing, labelling and Medical Device Reporting.
What is a 513(g) request and how much does it cost?: A 513(g) request asks FDA for a written statement of the class of a device and the requirements that apply to it. It is not a marketing authorisation. Section 513(g) gives FDA 60 days to answer. The FY2027 fee (1 October 2026 to 30 September 2027) is 8,596 USD, or 4,298 USD for a qualifying small business (91 FR 48134).
When does a change to a cleared device require a new 510(k)?: 21 CFR 807.81(a)(3) requires a new 510(k) for a change that could significantly affect safety or effectiveness (design, material, chemical composition, energy source, manufacturing process) or a major change in intended use. FDA guidance Deciding When to Submit a 510(k) for a Change to an Existing Device (2017) applies this test. Since the PCCP amendments, no 510(k) is needed for a change consistent with a predetermined change control plan cleared under section 515C (807.81(b)(1)(ii)).
Is a PMA-approved device automatically CE marked under the MDR?: No. The two regimes are independent. A PMA approval gives no CE marking, and a notified body certificate under Regulation (EU) 2017/745 is not an FDA authorisation. Test reports and clinical data can be reused where they meet both sets of requirements, but the regulatory file, UDI registration, post-market surveillance and quality system obligations follow separate texts. See our EU-US dual certification guide.
What is an IDE and when is it required?: The IDE (21 CFR Part 812) allows an unapproved device to be used in a clinical investigation. A significant risk device (812.3(m)) needs an IDE approved by FDA plus IRB approval. Significant risk means a potential for serious risk to subjects: an implant, a life-supporting device, a device of substantial importance in diagnosis or treatment, or any other device with that potential. Being invasive is not the test. Non-significant risk studies follow the abbreviated requirements of 812.2(b) under IRB oversight.
What changed with the QMSR on 2 February 2026?: The final rule published on 2 February 2024 (89 FR 7496) replaced most of 21 CFR Part 820 by an incorporation of ISO 13485:2016, with added FDA requirements (820.10 links to UDI, traceability, MDR reporting and corrections; 820.35 records; 820.45 labelling and packaging). It applies from 2 February 2026. FDA states it will not rely on ISO 13485 certificates for its oversight, and management review, internal audit and supplier audit records are no longer exempt from inspection.