Regulations (Overview) The FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms that manufacture, repackage, re-label, and/or import medical devices sold in the United States.
General steps to marketing clearance
1. Make absolutely sure that the product that you wish to market is a medical device, or meets the definition of a medical device according to the FD&C Act. For example, your product may be a medical device and is also an electronic radiation-emitting product with additional requirements.
2. Determine how the FDA may classify your device: Class I, Class II. or Class III. Classification identifies the level of regulatory control that is necessary to assure the safety and effectiveness of a medical device. Most importantly, the classification of the device will identify, unless exempt, the marketing process (either Premarket notification [510(k)] or Premarket approval (PMA)) the manufacturer must complete in order to obtain the FDA clearance/approval for marketing.
3. Develop/compile data and/or information necessary to submit a marketing application, and to obtain the FDA clearance to market. For some [510(k)] submissions and most PMA applications, clinical performance data is required to obtain clearance to market. In these cases, conduct of the trial must be done in accord with FDA's Investigational Device Exemption (IDE) regulation, in addition to marketing clearance.
Medical Specialty Categories
The FDA has classified and described over 1,700 different medical device types, which they have organized and categorized into 16 different medical specialties. These specialties are:
- Clinical Chemistry and Clinical Toxicology
- Ear, Nose, and Throat
- Gastroenterology and Urology
- General and Plastic Surgery
- General Hospital and Personal Use
- Hematology and Pathology
- Immunology and Microbiology
- Obstetrical and Gynecological
- Physical Medicine
Regulations (Approval Process)
Medical devices are classified into Class I, II, or III. Regulatory control increases from Class Ito Class III, and each classification has different regulatory requirements.
Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k), and most Class III devices require Premarket Approval. All other general control regulations apply to all medical devices in classes I, II, and III.
Marketing Clearance requirements for medical devices
- Premarket Notification, 510(k)
- Premarket Approval (PMA)
- Establishment Registration
- Medical Device Listing
- Quality System Regulations (QSR)
- Medical Device Reporting (MDR)
Premarket Notification, 510(k) -21 CFR Part 807 Subpart E
If your device requires the submission of a Premarket Notification 510(k) you can not commercially distribute the device until you receive a letter of substantial equivalence from the FDA authorizing you to do so.
A 510(k) must demonstrate that the device is substantially equivalent to one legally in commercial distribution in the United States: (1) before May 28, 1976; or (2) to a device that has been determined by the FDA to be substantially equivalent.
Premarket Approval (PMA) -21 CFR Part 814
Product requiring PMA are Class III devices, which are high-risk devices that pose a significant risk of illness or injury, or devices found not substantially equivalent to Class l and II predicates through the 510(k) process.
The PMA process is more involved and includes the submission of clinical data to support claims made for the device. The PMA is an actual approval of the device by the FDA
Establishment Registration - 21 CFR Pad 807
Manufacturers (both domestic and foreign) and initial distributors (Importers) of medical devices must register their establishments with the FDA.
Once a year, the FDA sends the registration form FDA-2891(a) to all registered firms to be verified, corrected, and
returned by the firm as a yearly registration. In addition, foreign manufacturers must also designate a U.S. Agent.
Medical Device Listing - 21CFR Part 807
A separate device listing form must be submitted for each type of device.
All medical devices that are manufactured and imported into the U.S. are required to be listed with the FDA on Medical Device Listing.
- Repackage and re-label
- Develop specifications
- Reprocess single-use devices
- Manufacture accessories and components sold directly to the end-user
Quality System Regulations (QSR)/Good Manufacturing Practices (GMP) -21 CFR Part 820
The quality system regulations and good manufacturing practices include requirements related to the methods used in and the facilities and controls used for designing, purchasing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices. Manufacturing facilities undergo FDA inspections to assure compliance with the QSR and GMP requirements.
Labeling - 21 CFR Part 801
Labeling requires that you include labels on the device as well as descriptive and informational literature that accompany the device.
Medical Device Reporting - 21 CFR Part 803
Incidents in which a device may have caused or contributed to a death or serious injury most to be reported to the FDA under the Medical Device Reporting program. Besides, certain malfunctions must also be reported.
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- Regulatory Compliance
- Due Diligence Evaluation for cGMP / Quality Systems
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- 510(k) submissions
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- Perform critical reviews of prepared submissions
- Preparation for FDA pre-approval inspections
- Performance of mock-FDA inspections
- Company Registration
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- Audits of suppliers, manufacturers, toxicology houses, etc.
- Development of manuals: Site Master File (EU requirement), Quality Manual, Quality Policy Manual (ISO 9001:1994, ISO 9001:2000, ISO 13485:1998, ISO 13485:2003)
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