- The Food and Drug Administration is an agency within the US Dept. of Health and Human Services. They are responsible for protecting and promoting public health by regulating and supervising: food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, and veterinary products. They also enforce other laws, which include sanitation requirements and control of disease on various products. Overall, the FDA regulates over $1 trillion worth of consumer goods, or 25% of consumer expenditures in the US. Around 50% of the FDA’s budget is generated by user fees, mostly from pharmaceutical firms to expedite drug reviews. The proposed 2014 budget is $4.7 billion.
- Establishment Registration by manufacturers, distributors, repackages and re-labelers,
- Medical Device Listing with FDA of devices to be marketed,
- Manufacturing the devices in accordance with Good Manufacturing Practices,
- Labeling medical devices in accordance with the labeling regulations, 21 CFR 801 or 21 CFR 809,
- Medical Device Reporting of adverse events as identified by the user, manufacturer and/or distributor of the medial device.
- 'display of written, printed, or graphic matter upon the immediate container of any article...'
- The term 'immediate container' does not include package liners. Any word, statement, or other information appearing on the immediate container must also appear 'on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container of a wrapper.'
- 'all labels and other written, printed, or graphic matter(1) upon any article or any of its containers or wrappers, or
- (2) accompanying such article' at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.
- Device trade or proprietary name, common or usual name or classification, Class of the device (Class I, II, III)
- Submitter's name and address, Contact person, telephone number and fax number, Representative/Consultant if applicable
- Name and address of manufacturing/packaging/sterilization facilities, Registration number of each manufacturing facility
- Action taken to comply with the requirements of the Special Controls.
- Proposed labels, labeling, and advertisements to describe the device, its intended use, and the directions for its use.
- 510(k) summary or a 510(k) statement.
- For Class III medical device, a Class III certification and a Class III summary.
- Photographs of the device, Engineering drawings of the device.
- Identification of the marketed device(s) to which equivalence is claimed including labeling and description of the medical device.
- Statement of similarities and/or differences with marketed device(s)
- Data to show consequences and effects of a modified device, performance Data (bench, animal, clinical)
- Sterilization information (as applicable)
- Software development, verification and validation information
- Hardware design and development information
- Information requested in specific guidance documents (as applicable)
- Kit Certification Statement (for a 510(k) submission with kit components only)
- Truthful and Accurate Statement
- A written MDR procedure,
- MDR event files,
- Individual adverse event reports,
- 5 day MDR reports of remedial action taken to prevent unreasonable risk of substantial harm to public health,
- 30-day MDR reports of deaths, serious injuries and malfunction attributed to the medical device,
- Baseline reports for the medical device.
Since the task is so vast, the FDA is divided into many offices and centers. An important one is the Office of Regulatory Affairs, run by Consumer Safety Officers, or Investigators, who inspect production facilities, investigate complaints/illnesses/outbreaks, and review documentation. The Office of Criminal Investigation consists of OCI Special Agents, who pursue and develop cases where criminal actions have occurred. They work closely with the FBI, Assistant Attorney General, and Interpol, making them the enforcers to make sure the FDA regulations are followed. However the group concerned with medical devices is the Center for Devices and Radiological Health (CDRH), which regulates firms who manufacture, repackage, relabel, and/or import medical devices in the US.
Safety regulatory programs vary based on the type of product, its potential risks, and the powers granted to the agency. Since for this summer, we are most likely going to be working with FES class 2 devices, I decided to focus on the approval process for that category. However first it was important to understand the classification of medical devices. According to myraqa, classification is based on 2 factors: (1) the level of risk to the consumer, and (2) whether or not other products like it have been previously approved/level of regulatory control the FDA determines is needed to legally market the device.
Class I devices are products that present a very low risk to the consumer and are substantially equivalent to other market products. When a company produces a Class I medical device, they must register their company and the product with the FDA, but most of the time further scientific review is not necessary. These devices could also be further exempt from the Quality System Regulations (QSRs).
Class II devices are products substantially equivalent to previously approved products, but need additional study and control. They are subject to scientific review by marketing applications (510ks) or premarket notifications, and must be manufactured in a QSR compliant market. A clinical trial may be needed as well. There is a special category for products that have Class II risk but no previously cleared product (predicate device), which is review via a de novo 510(k) route.
Finally, Class III devices are products where there is no predicate device or the FDA considers it too high of a risk to down-classify. Insufficient information exists to know whether general or special controls are adequate for safety and effectiveness. They require submission of a Premarket Approval application (PMA).
Medical devices in general are subject to General Controls, premarketing, and postmarketing regulatory controls. General Controls include:
Pre-marketing controls are device and device classification specific. The majority of Class II medical devices are cleared for market by submission and FDA review of a 510(k) Premarket Notification submission. The information required is defined 21 CFR 807.87, and includes:
Post marketing controls include: Device Listing, Medical Device Reporting (MDR), Establishment Registration and Quality System Compliance Inspection. For Device Listing, most medical device establishments registered with the FDA must list the devices they have in commercial distribution, which is completed by the classification name assigned to the medical dive. This step should be completed within 30 days of entering into commercial distribution and is updated when newly entered, marketing is discontinued, or marketing of discontinued device is started again. MDR regulation requires firms who have received complaints of device malfunctions/serious injuries/deaths associated with the medial devices to notify FDA of the issue. This requires:
-Vivien Zhang