Medical Device Resources
Useful Links for Medical Device Organizations
FDA Databases
Medical Device Databases
The Universal List of FDA databases for medical device.
Product Classification Database
The database shows the identification of device based on common medical device names and associated information. It helps to search and identify device classification (I, II, or III), 3-letter Product Code, whether it’s subject to GMP, Submission Type (exempt, 510(k), or PMA), Premarket Review party, and so on.
510(k) Premarket Notification Database
The database of submitted FDA 510(k)s devices. It can be searched by 510(k) number, applicant, device name or FDA product code.
Premarket Approval (PMA) Database
The database to search FDA Medical Device Premarket Approval information for submitted Class III devices.
Establishment Registration & Device Listing Database
This database shows the establishments (manufacture, assembly, processing, preparation, compounding, propagation of medical devices intended for human use and commercial distribution) and their list of registered devices.
Global Unique Device Identification Database (GUDID)
The database to search Unique Device Identifiers (UDI) for registered medical devices based on manufacturer, device name, model number, and associated information.
FDA Regulatory Guidance
Design Control Guidance For Medical Device Manufacturers
The guidance for FDA 21 CFR 820.30. This is guideline defines the phases of DHF and major deliverable.
Established Registration & Device Listing
The instruction to register FDA as an establishment and the annual registration user fee for given fiscal year.
Who (Establishment) Must Register, List and Pay the Fee
A matrix of parties that are required to register with FDA. It explains who must and who doesn’t have to register.
How to Determine if Your Product is a Medical Device
It explains methods to find out what qualifies as a FDA regulated medical devices. Start with FDA Product Classification Database to see whether the generic name of your device is classified as a medical device. Then search 510(k) and PMA databases to see whether the equivalent or similar product is found in the database.
Types of 510(k) Submission Programs
It explains difference between 3 types of 510(k)s: Traditional, Special, and Abbreviated
Is a new 510(k) required for a modification to the device?
This guidance tells whether the change of medical device requires new premarket notification 510(k) review by the FDA. The major changes requires new 510(k) while minor changes won’t.
Premarket Approval (PMA)
It outlines when PMA is required for FDA regulated Medical Devices, Devices Used in Blood Establishments, Data Requirements, and other references.
Medical Device Standards
ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes
The standard specifies the Quality Management Systems for manufacturing and distribution of Medical Devices. The basis of SOP and Best Practice.
ISO 10993-1 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
This document outlines the biocompatibility requirements for medical devices. Currently part 1 to part 22 (part 21 doesn’t exist). The medical device manufactures test their device based on applicable specification and features of the device. Only those clauses applicable to the device should be tested.
IEC 62366-1 Medical devices — Part 1: Application of usability engineering to medical devices
The risk assessment of medical device for intended use. It specifies what risks are associated with the device use, what needs to be tested to ensure the safety of device operations, what labeling, caution, and warning statement needs to be on the DFU, Operators Manual, or device itself.
ISO 14971 Medical devices — Application of risk management to medical devices
This document becomes the basis of medical device risk management report.
IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
The list of specification and testing requirements for medical devices. It outlines the risk and potential hazard of features and specification. Even if the device is not electronically actuated, some clauses may be applicable.
IEC 62304 Medical device software — Software life cycle processes
It outlines how the medical device software specification should be written.