Abbreviated 510(k) – When the abbreviation is allowed
Abbreviated 510(k) is one of three 510(k) clearance procedures offered by the FDA. This article tells you,
DetailsThe Food and Drug Administration (FDA) is a US authority responsible for the approval and market surveillance of food, drugs, cosmetics, and medical devices. It is authorized to issue its laws, which can be found in 21 CFR. The authority thus acts as both a legislative and executive body.
Content
This page provides manufacturers of medical devices with an overview of the FDA’s requirements and links to relevant articles.
- Approval and communication with the authority
- Requirements for the QM system
- Guidance documents
- Support for the approval of devices in the USA
1. Articles on approval and communication
a) Articles on approval procedures
The article “FDA approval of medical devices” provides you with an introduction. It shows you how to
- determine the correct “Medical Device Panel” and the type of your medical device,
- classify the device, and
- select the appropriate approval procedure.
| Approval procedure | Suitable for devices, … |
| Premarket Notification PMN, also known as 510(k) | for which there is already an approved substantially equivalent device, the so-called predicate device. There are also special forms here. |
| Abbreviated 510(k) | for which the FDA has published guidelines with “special controls”, which the manufacturer applies |
| Special 510(k) | which the manufacturer had already approved and which the manufacturer intends to re-approve following a modification |
| Premarket Approval (PMA) | that are critical and for which there are no benchmark devices |
| De novo procedure | that are not highly critical and for which there are no benchmark devices |
| Investigational Device Exempt (IDE) | used in the context of clinical investigations |
| Humanitarian Device Exemption | which are still experimental and are generally intended for use in terminally ill patients |
| Breakthrough Medical Devices | which are for patients with critical or even life-threatening illnesses and injuries |
| Safer Technologies Program | that increase safety compared to alternative devices and are intended for patients who are less critically ill or injured. |
| Precertification (Pre-Cert) Pilot Program | which are software and represent innovation. |
b) Articles on communication with the FDA
The US Department of Health and Human Services has regulated and formalized communication with manufacturers.
| Law and official communication channel | Area of application |
| Request for Information | Suitable for alignment, e.g., on the classification of a device |
| Pre-Submission Program (Pre-Sub) | Suitable for alignment on the approval strategy |
| Warning Letter Form 483 | Formal letter from the authority in the event of severe deviations found during an FDA inspection, for example. This requires a remediation. |
| Refuse to Accept Policy | Minimum requirements for the submission of approval documents for 510k approval |
| eCopy-Programm | Specifies how approval documents must be structured and submitted electronically |
| eStar-Programm | Successor to the eCopy program |
Tip
The Johner Institute supports medical device manufacturers in official communications with the FDA. We help you select the right channel and prepare the meetings so that the authority provides binding information.
c) Further articles
The FDA requires a US Agent & Official Correspondent for the registration of medical devices.
2. Articles on the requirements for the QMS
The Quality System Regulation (QSR) in 21 CFR part 820, which the FDA broadly aligns with the requirements of ISO 13485, is essential. The FDA refers to this new regulation as QMSR, Quality Management System Regulation.
Further information
Please refer to the extensive collection of articles on quality management and ISO 13485.
When inspecting QM systems, the FDA follows the FDA QSIT: Quality System Inspection Technique.
During these audits, the FDA examines the objective evidence. If manufacturers provide this evidence electronically, they must comply with the electronic signature requirements of 21 CFR Part 11.
Development
With the changeover to ISO 13485, the requirements for the following documents or files become partially obsolete: Design history file, device master record, and device history record. However, ISO 13485 requires similar records.
Manufacturers are still obliged to describe:
- Design input: What you should not forget
- Design output: What is it and what must it contain?
- Design verification of medical devices and standalone software
- Design validation: What you have to prove
3. Articles on the guidance documents
The legal requirements in the USA are often generally applicable. The FDA has, therefore, published countless guidelines.
a) Software
| Guidance Document | Area of application |
| Software Validation | Software that is a medical device or part of a medical device, as well as software that is used as part of QM processes, e.g., for production control
Please also refer to the articles on process validation and Computerized Systems Validation (CSV). |
| Interoperable Medical Devices | Software with external interfaces, in particular to other medical devices and clinical information systems |
| Medical Device Data Systems (MDDS) | Devices (hardware and/or software) that are primarily intended to transmit data |
| Leven of Concern | Any software: The guidance regulates the scope of the documentation to be submitted. |
| Off-the-shelf (OTS) Software | Software that contains generally available software, in particular libraries |
| Software-Change | This Guidance Document is always relevant if a manufacturer wants to change the software and has to decide whether a new approval is necessary. |
| Cybersecurity (several guidance documents) | Interoperable medical devices that are or that contain software |
Further information
Please also note the extensive information on software development, including information on detailed design and mobile medical apps.
The article on the qualification of standalone software is also relevant.
b) Security
Almost all medical device manufacturers whose devices contain or are software must also comply with the IT security and cybersecurity guidelines. The article “Cybersecurity in Medical Devices: The FDA’s Guidance Documents”.
The FDA is generous when it comes to pure security patches.
The FDA recognizes some standards on IT security as “consensus standards,” including UL 2900.
c) Usability
The FDA Human Factors Guidances article is the best place to start, as it presents the two guidance documents and how they interact.
One of these documents is the FDA Human Factors Engineering Guidance.
d) Clinical evaluation
The FDA handles clinical evaluation differently from the EU. For example, devices with a “predicate device” are considered to have provided this evidence. Nevertheless, the FDA has drawn up a guideline on the clinical evaluation of software.
e) Risk management
FDA Benefit-Risk Guidance
FDA MAUDE database: Input for risk management
f) Articles on post-market surveillance and vigilance
The US authorities also have several requirements for the phase after placing on the market, e.g.
- in 21 CFR part 822 for post-market surveillance,
- for recalls, and
- for dealing with safety gaps in the Health Breach Notification Rule.
Caution!
The Federal Trade Commission (FTC) requirements must also be observed in the case of security gaps!
4. Support with the approval of medical devices in the USA
Do you still have questions about approving your medical device in the USA? Then, benefit from free micro-consulting.
The Johner Institute supports medical device manufacturers in all activities:
- Determining the regulatory & approval strategy (FDA and worldwide)
- Classification of devices
- Communication with the authority, e.g. at Q-meetings
- Registration & listing
- Remediation (rapid elimination of deviations identified by the FDA)
- Post-market surveillance
- Taking on the role of the US agent
Software change: What the FDA expects from you
In a guidance document, the FDA explains how to implement a software change in a regulatory-compliant manner. It describes when you need a new 510(k) submission (Premarket Notification) and when you “only” need to document the changes.
DetailsRecognized consensus standards of the FDA
The FDA offers manufacturers the opportunity to use so-called recognized consensus standards for the approval of their devices. The US authority has published a “guidance” document on these consensus standards, presented in this article. It also describes the requirements for using the standards and the advantages for manufacturers, but also points out typical mistakes.
DetailsHealth Breach Notification Rule
The Health Breach Notification Rule defines when health records providers have to report which security issues to whom, within what time frame and in what form. This article provides a brief overview of the requirements of the US Federal Trace Commission (FTC).
Federal Trade Commission FTC: for medical device manufacturers?
The Federal Trade Commission (FTC) is an US agency that aims to ensure compliance with competition law and consumer protection. This article explains the circumstances that require you (e.g., as a medical device manufacturer) to comply with the FTC requirements and the specifics of these requirements. The case of Lumosity shows how radically the FTC…
DetailsFDA MAUDE database: Input for risk management
The FDA MAUDE database provides information on the “Manufacturer and User Facility Device Experience.” It thus corresponds roughly to the database used by the BfArM to publish manufacturer reports on risks.
Design History File: Device Master Record, Device History Record
The FDA requires a Design History File DHF in 21 CFR Part 820 (these are the “Quality System Regulations”). DHF should not be confused with the Device History Record DHR or the Device Master Record DMR. This article explains what the Design History File must contain and how it differs from the other two “files.”
