GOOD MANUFACTURING PRACTICES EXEMPTIONS
- Component Manufacturers: A "component" is defined by 21 CFR 820.3 (c) as "any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished,packaged,and labeled device."
- Remanufacturer: A remanufacturer as defined in 21 CFR 820.3 (w) is “any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that changes the finished device's performance or safety specifications or intended use."
- Custom Device Manufacturers: (21 CFR 812.3 (b)) defines a custom device. Compliance with premarket approval is not required and are exempt from certain statuary requirements .But, they are not exempt from GMP requirements.
- Contract Testing Laboratories: These are laboratories that are hired by the manufacturer on certain specifications for testing components or devices and hence are considered as an extension of the manufacturer's quality system and are therefore are not subjected to GMP inspections.
- Repackagers, Relabelers, and Specification Developers: In 21 CFR 820.3(o) and 21 CFR Part 807, Repackaging and relabeling of a device and specification development are defined as manufacturing devices. As per 21 CFR 820.3, repackager or relabeler is a manufacturer and subject to QS regulation. Individuals are re packagers or relabelers if they, pack or label an already packed or labeled product again,if they pack and label separately the products received in bulk,or prepare kits by combining the different products received in bulk.
Apart from the exempted establishments, there are certain categories that seem to be simple,but actually they are necessary for the use of the complicated devices for health purposes. These categories include:
Accessories Manufacturers: Accessory devices are considered as finished devices by FDA as,they are suitable for use for health related purposes. The QS regulation applies to their manufacturing. The devices such as hemo-dialysis tubing or x ray components are used along with medical devices and are responsible for general public health standards. The manufacturing of these require compliance with the GMP requirements.
Initial Distributors of Imported Devices: The initial distributer is the one who distributes the product for the first time and is responsible for setting up standard of device .Initial distributer maintains records and receive and process complaints. Complaints include even oral complaints. All the complaints are evaluated and decision is made that whether it needs to be informed to FDA or not. Evaluation is made under the FDA Medical Device Reporting 21CFR part 804 or 803.
