Classification

Medical Devices are classified by Regulation, that is detail descriptions are contained within the Code of Federal Regulations (21 CFR 862 - 892), and various classifications and requirements listed for each device. There are three classes: class 1 are the lowest risk devices and class 3 are the highest risk devices.

The classification regulation will also state whether the device is subject to Good Manufacturing Practice (GMP) requirements: most class 1 devices are exempt and most class 2 or 3 devices are subject to them.

All Medical Devices have to be listed with FDA, in addition: most class 2 devices are subject to a Pre-Market Notification 510(k) procedure and most class 3 devices are subject to a Pre-Market Approval (PMA) Process.

Establishment Registration and Product Listing

The owner or operator of an establishment for the manufacture, preparation, propagation, compounding, assembly or processing of a Medical Device is required to register it with FDA. Each Medical Device must be listed with FDA.

U.S. Agent

The Foreign Establishment means any of the follows:
1. Medical device manufacturers
   
2. Human drug manufacturers
   
3. Animal drug manufacturers
   
4. Biological manufacturers
   

• Assist the FDA in communications with the foreign establishment.
• Respond to questions concerning the foreign establishment's products that are imported or offered for import into the United States.
• Assist FDA in scheduling inspections of the foreign establishment.
• If the FDA is unable to contact the foreign establishment directly or expeditiously, the agent will facilitate information or document exchange between the FDA and the foreign establishment.
• The agent will file either the Initial Registration Device Establishment Form 2891 (if you have previously never registered with FDA) or file the Annual Registration of Device Establishment Form 2891(a).

As one establishment can only appoint one U.S. Agent it is not always desirable to appoint a distributor, for example, where the manufacturer uses more than one distributor.

Pre-Market Notification, frequently called 510(k)

This is a notification made under section 510(k) of the Federal Food , Drug and Cosmetic Act, FD+C Act, of the intention to manufacture a Medical Device. The notification is to demonstrate to FDA that the device is substantially equivalent to another that was on the market prior to May 28, 1976, or a device the has already been cleared through the 510(k) process. If FDA agrees, they will issue a determination of substantial equivalence.

There are many variations to this procedure that may be applicable to a particular situation, for example: third party review, special 510(k)'s (for changes to existing devices), abbreviated 510(k)'s (for products conforming to agreed standards). In certain circumstances some additional certifications are also required.

Pre-Market Approval (PMA)

This is a formal approval of the safety and effectiveness of a device by FDA based on valid scientific data and rational. A PMA is an order of magnitude more stringent than a 510(k) because it is an absolute, not merely a comparison, process

A PMA can be a traditional large submission at the end of the design process, or a Modular submission, where modules are submitted and reviewed at agreed project-milestones. A Product Development Protocol, PDP, is an extension of this concept, where a protocol for development is agreed in advance and data reviewed in realtime. Both these options can reduce the time spent waiting for an approval at the end of the project but require confidence that the development will proceed according to plan.

GMP- Good Manufacturing Practice (Quality System Regulation, QSR)

The Good Manufacturing Practice (GMP) regulations in 21 CFR 820 are based on ISO 9001 (pior to the inclusion of continuous improvement et al in ISO9000:2000) and usually refered to as the Quality System Regulation (QSR). There are however significant differences between the requirements and for a manufacturer selling into both US and EU markets it is essential to design a quality system that meets both.

FDA conduct inspections of manufacturers to assess compliance. FDA have a program of recognizing third parties to conduct these inspections on their behalf. Non-Compliances are legal infractions and consequently far more significant than any found during a Notified Body's or Registrar's Audit.

Medical Device Reports

There are specific legal requirements and time-frames for reporting to FDA instances of malfunction, harm or death involving devices, as well as "near-misses". It is important to assess all customer communications against the reporting criteria.

Changes and Re-Designs

Depending on the circumstances these can require: no formal submission to FDA (merely in-house documentation), a full or partial prospective resubmission or a retrospective submission. Compliance with the Design Control elements of the QSR is essential.