The manufacture of new medical devices is regulated by The Food and Drug Administration (FDA). Compliance is essential to ensure the safety and effectiveness of these products for consumers. Here’s what manufacturers of these devices need to know.
The Center for Devices and Radiological Health (CDRH) is a branch of the FDA that deals specifically with standards and procedures relating to medical devices in the USA. This includes the monitoring of radiation-emitting electronic items, whether for medical or non-medical use. Examples of these products are color televisions, microwave ovens, ultrasound systems, x-ray equipment, and lasers.
The FDA categorizes medical devices into Class I, Class II, and Class III. Each classification comes with its own regulatory requirements. Those items that fall into Class I do not require a Premarket Notification 510(k), whereas Class II does need it. With Class III, a full Premarket Approval has to take place.
There are several steps involved in the process of complying with the FDA regulations for medical devices. It is up to the identified parties to make sure that they have a good grasp of what this entails and that they complete the necessary stages of the process that are applicable to them.
The steps are as follows. Firstly, the company must undertake establishment registration before they can produce medical devices. Secondly, they need to obtain a listing for their medical device. The third step is either premarket approval or premarket notification 510 (k), dependent on which one applies to the business concerned. In step four, where clinical studies are implicated, an IDE (investigational device exemption) is needed. The fifth step covers labeling, and the final step is the MDR (Medical Device Reporting).
The FDA has numerous responsibilities, one of which is to ensure that medical devices are regulated, and proof obtained of their efficacy and safety from the manufacturers. However, the authority of the FDA is not unlimited. IT does not determine how doctors or nurses carry out their practices. Nor does it provide them or any health care facilities with specific recommendations. Additionally, it does not assess medical devices by assigning a rating over and above the determination of what falls into Classes I, II, and III.
MedWatch is the FDA’s Safety Information and Adverse Event Reporting Program. Anyone can report a problem with a medical device or pharmaceutical product. This includes consumers, health care professionals, manufacturers, or any other interested party.
The FDA recommends Compliance Certification from businesses manufacturing medical devices. It is essential that these devices remain safe and continue to operate as specified throughout their product lifecycle. Thus, the FDA makes provisions for the repairs and maintenance of medical devices.
Good Manufacturing Practices (GMP) are supported by the FDA. To this end, it has instituted Quality System Regulations (QSR) and will enforce compliance if necessary. Nevertheless, it is not good practice to rely on enforcement to ensure the quality of goods. That is why compliance certification is required.
Manufacturers should align themselves with the FDA’s regulatory requirements and obtain compliance certification as proof of the quality of their medical devices.