US FDA Clearance

20 April 2020

Quality First International provides:

  • Designation and classification of your device
  • Register your establishment
  • Preparation of Premarket Notification 510(k) submissions
  • Complete Product Development Protocols
  • Secure Investigational Device Exemption (IDE)

When entering the US marketplace, a medical device manufacturer must subject his medical device to the general controls of the Federal Food Drug & Cosmetic (FFD&C) Act which are contained in the final procedural regulations in Title 21 of the Code of Federal Regulations Part 800–1200 (21 CFR Parts 800–1299). Essentially, the manufacturer must first designate the product as a medical device or in vitro diagnostic for example and ensure that it must be regulated by the Center for Devices and Radiological Health (CDRH). Next the device must be classified into one of three classes, identifying the level of regulatory control. The classification of the device will identify, unless exempt, the process (either premarket notification [510(k)] or premarket approval (PMA)) the manufacturer must follow in order to obtain FDA approval.

QFI has directed many companies through the US FDA process. Our Technical Specialists are well versed in FDA requirements and adept at developing the data and information necessary to obtain FDA clearance as follows:

  • Designate and classify your device
  • Register your establishment
  • List your device
  • Obtain Premarket Approval where necessary
  • Prepare Premarket Notification 510(k) submissions where a predicate device exists on the US market
  • Verify that the predicate device meets the appropriate criteria, where necessary
  • Complete a Product Development Protocol
  • In the case of Investigational Device Exemption (IDE) regulation, manage clinical trials to eventually obtain marketing clearance
  • Secure Investigational Device Exemption approval as required
  • Conduct a Hazard Evaluation
  • Prepare the Safety and Efficacy summary
  • Assist in adhering to appropriate labeling regulations
  • Communicate with the FDA Office of Device Evaluation to determine any special requirements
  • Concerning the device in question
  • Satisfy the postmarket surveillance controls, including the Quality System (QS) or Good Manufacturing Practices (GMP)
  • Prepare, if necessary, responses to the FDA’s request for additional information
  • Report adverse events following Medical Device Reporting (MDR) regulations
  • Provide on-site regulatory support during Establishment or compliance inspection by US FDA

Furthermore, Quality First International can help you respond to a FDA Form-483 or Warning Letter from the US FDA. Usually received after an on-site audit by the FDA with a list of deficiencies determined by the inspection, you must respond in writing with a detailed action plan in response to each point made in the letter, providing a timeline to correct the issue. Quality First International can support corrective actions to address any issues identified by the audit and help clients prepare an effective response to the Form-483 or FDA Warning Letter.