.. ed for one or more features included in the product, the Product Team Leader should incorporate the submission strategy into the design plan for the product. The strategy should include both the number of submissions required for the product (individual features may be submitted separately) and the type of submission to be filed for each feature. Based on the type of feature/product and the needs of the business, the Regulatory group may recommend one of the four types of 510(k) submissions. ? Special 510(k): This type of a submission can be used in cases where there is no change in the intended use of the device or in the fundamental scientific technology of the device.
Instead of submitting data to support the submission, the manufacturer submits a “Declaration of Conformity” with the design control requirements in the Quality System Regulations and a brief summary of their design control process. All design control activities and verification/validation tests specified in the Risk Analysis must be completed at the time of the submission. The advantage of this type of submission is that FDA will make a clearance decision in 30 days. ? Abbreviated 510(k): This type of a submission can be used in cases where there is a device-specific guidance document or FDA has recognized a relevant consensus standard. Instead of submitting data to support the submission, the manufacturer submits a “Declaration of Conformity” to the recognized standard and a brief summary of the activities taken to meet that standard.
All activities required by the recognized standard must be completed at the time of the submission FDA does not guarantee a shorter review time with this type of submission, but they believe review times should be shorter. ? Traditional 510(k): This type of a submission can be used in all cases These submissions can contain promissory notes on activities that will be done prior to commercial distribution, but have not necessarily been completed at the time of the submission. FDA is supposed to give a clearance decision for the submission in 90 days. Note: if they formally request (i.e. in writing) additional information, the review time clock starts over at zero once that information is submitted.
? Third-Party Reviewed 510(k) These submissions are similar to traditional 510(k) submissions. However, the initial review is conducted by a qualified third party at a predetermined expense. Once the third party completes the review, the submission is forwarded to FDA for final review and clearance. Although there is a cost involved with this submission, the review time is typically shorter (30-45 days) since they bypass the queue of submissions at FDA. The Regulatory Affairs Group prepares and submits all documentation required for FDA approval/clearance of new products and modifications/ upgrades to existing products. The team is responsible for all interactions with government regulatory agencies and Industry Relations (Corporate) Department. It also monitors and follows-up Medical Device Reporting (MDR) requirements and monitors compliance with the Safe Medical Devices Act and other medical device legislation.
When a manufacturer decides to modify an existing device, they must decide whether the proposed device modification requires submission of a 510(k). It is not FDA’s intent that a 510(k) must be submitted for every modification. However, all changes in indications for use require the submission of a 510(k). Examples of modifications that may require a 510(k) submission include the following: ? Sterilization method ? Structural material ? Manufacturing method ? Operating parameters or conditions for use ? Patient or user safety features ? Sterile barrier packaging material ? Stability or expiration claims ? Design FDA believes that the manufacturer is best qualified to determine when modifications to their device could significantly affect safety or effectiveness. Therefore, every modification to the device should be reviewed by appropriate personnel to determine if it affects safety or efficacy.
If it is determined that the modification is not significant, the basis for this decision should be documented with supporting data in the manufacturer’s device master file. If it is determined that the modification is significant, then a complete 510(k) must be submitted to FDA. If FDA finds the device to be substantially equivalent, FDA will send the manufacturer a marketing clearance letter, referred to as an “SE letter”, and the device may be marketed as described in the 510(k). If FDA finds the device not to be substantially equivalent, FDA will send a not-substantially equivalent letter. In the latter instance, the manufacturer may chose to resubmit another 510(k) with new information, may petition FDA requesting the device be reclassified or may submit a PMA. Manufacturers may not place their device into U.S. commerce until they receive a marketing clearance letter from FDA.
Once they receive the approval letter, they can then sell the product to the U.S. market. In addition, before clearance is obtained the manufacturer must assure that the device is properly labeled in accordance with FDA’s labeling regulations. Once clearance for marketing is obtained, the manufacturer must register their establishment and list the type of device they plan to market with the FDA. Finally, once on the market, there are postmarket surveillance controls that a manufacturer must comply with; these include the Quality Systems and Medical Device Reporting (MDR) regulations. The QS regulation is a quality assurance requirement that covers the design, packaging, labeling and manufacturing of a medical device.
The MDR regulation provides a mechanism for FDA and manufacturers to identify and monitor significant adverse events involving medical devices. The goals of the regulation are to detect and correct problems in a timely manner. Although the requirements of the regulation can be enforced through legal sanctions authorized by the Federal Food Drug and Cosmetic Act, FDA relies on the goodwill and cooperation of all affected groups to accomplish the objectives of the regulation. Analysis The medical device industry tends to comply with all government regulations to get the product to market. The more time it takes to get the product to market, the less money the business makes. Many laws tend to be vague and are subject to interpretation.
The problem for medical device manufacturers is that many of the laws are broad and written for drugs and not for medical devices. As a consumer, the FDA is an excellent regulatory body to have around. For an industry however, it can be very difficult to get through all the red tape. Entire regulatory departments are needed just so the necessary paperwork can be generated for market approval. The FDA does recognize that through constant modification to the existing laws, and assisting the medical device industry in obtaining market approvals, together industry and government can work together to improve healthcare for the general public. Bibliography 1.
Marconi Medical Systems, Inc. MR GBC Work Instruction MR 313. 2. Duane Praschan, former Regulatory Affairs manager, Marconi Medical Systems. 3.