In the area of medical technology, it is of uppermost importance to be keen in FDA regulation of medical devices.
When you introduce technological advancements and developments to the medical device market, first your device must undergo all the required regulations and legislations in order that the requested safety and efficacy standards required by the law are met.
Medical device regulations
The Food & Drug Administration (FDA) oversees medical devices in the USA with the goal of ensuring the safety & efficacy of the devices. This service is covered by the Centre for Instruments and Radiological Protection (CDRH).
FDA categorizes medical devices three risk-based grades, i.e. class I, II, and III. medical instruments. The least associated risk will be in Class I devices and the highest will be in Class III devices. As a result, from Class I to Class III devices regulatory authority increases.
Different types of FDA regulations
The following specific regulations must be complied with by US-based manufacturers & distributors and understood one by one
- Premarket Notice 510(k)-21 CFR Part 807
- Subpart EPremarket Approval (PMA)-21 CFR Part 814
- Investigational Product Exemption (IDE) for clinical trials-21CFR Part 812
- Quality System (QS) regulation 21 CFR Part 820
- Labeling requirements-21 CFR Part 801
- Medical Device Reporting (MDR)-21 CFR Part 8032
- Quality System (QS) regulation 21 CFR Part 820
In this respect, most Class I devices are exempted from the submission of 510(k) premarket notification, while the majority of Class II devices are submitted for premarket notification. On the other hand, the Premarket Approval Application (PMA) is required for Class III devices and other Class III devices exempted from the PMA are required to apply a 510(k) notification to the FDA.
Conclusion
For more details regarding medical devices FDA regulations,
you can link to the FDA website .
In any case, you must certainly get a profound overview of the FDA regulations for medical devices before you start your medical product development.
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