Types of regulatory approvals:

The following types of regulatory pathways are used for to avail USFDA approval for commercialization of a medical device into market.

1. Premarket notification (510(k)): This regulatory pathway is a fast track system used for devices which do not require any clinical data and are substantially equivalent to a predicate device (similar in use and technological characteristics).
2. Premarket approval: This regulatory pathway is used for devices which are not substantially equivalent to any medical device established in the market and requires clinical data evidence for proving safety and effectiveness.
3. Humanitarian device exemption: This pathway is applicable for devices which are used for patients with rare diseases or conditions

Medical Device reporting (21 CFR Part 803):

Mandatory reporting (Form FDA 3500A): The following stakeholders are responsible for mandatory reporting of medical device associated deaths, injuries and malfunctions to the FDA.

Manufacturer & Importers: The following scenarios of medical device associated safety concerns requires reporting.

1. Device related deaths or serious injuries
2. Device contributed deaths or serious injuries
3. Device malfunctions which could likely cause or contribute to a death or serious injury.

Manufacturers are obliged to report the above safety concerns to USFDA. Whereas, the Importers are obliged to report the above safety concerns to both manufacturers and USFDA.

Device user facilities: A “device user facility” is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician’s office. The following safety concerns associated with medical device are required to report both FDA and manufacturer.

1. Device related deaths or serious injuries
2. Device contributed deaths or serious injuries

The reporting pertaining to device malfunctions is a voluntary advice and not mandatory for device user facilities.

Voluntary reporting (Form FDA 3500B):

Healthcare professionals, patients, caregivers and consumers are encouraged to submit voluntary reports of significant adverse incidents/events or problems with medical devices to FDA by submitting 3500B form electronically.