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The Starting Line: Turning the Corner with a Device Concept

Regulatory Reality
Many Class I devices are exempt from premarket clearance or approval requirements because they are low risk. Class II devices generally require 510(k) clearance, while Class III devices will require PMA. Premarket clearance is by far the most common pathway to market, with more than 93 percent of devices being cleared through the 510(k) process.

As you can imagine, it is a joyful day when the inventor learns that his concept device is Class I. The trail is straight and lacks many of the encumbrances realized when filing a submission to the Federal government. Of course, there is still labeling, instructions for use, packaging, manufacturing, etc., but definitely not the maze that has to be negotiated with a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as (that is, substantially equivalent to) a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. Until the submitter receives an order declaring a device Safe and Effective (SE), the submitter may not proceed to market the device. Once the device is determined to be SE, it can then be marketed in the U.S. The SE determination is usually made within 90 days and is made based on the information submitted by the submitter. FDA is required to rule on a 510(k) submission within 90 days of receipt, but the process often takes considerably longer due to questions raised by FDA while it evaluates the submission, which can reset the 90-day clock depending upon the extent of questioning.

A claim of substantial equivalence does not mean that the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards and other characteristics, as applicable.

Note: FDA does not perform 510(k) pre-clearance facility inspections. The submitter may market the device immediately after 510(k) clearance is granted. The manufacturer should be prepared for an FDA quality system (21 CFR 820) inspection at any time after 510(k) clearance. There is always that possibility. In this case, the contract manufacturer may draw the short straw.

It is Never Too Early to Start Thinking about Design Controls
Probably one of the hardest parts of this early development process is convincing a research-oriented surgeon that design and development planning is needed to ensure that the design process is appropriately controlled, and that device quality objectives are met. The plans must be consistent with the remainder of the design control requirements, and lay a foundation for further development in a methodical and documented fashion. Typically, the following elements would be addressed in the design and development plan:
• Description of the goals and objectives of the design and development program; i.e., what is to be developed;
• Delineation of organizational responsibilities with respect to assuring quality during the design and development phase, to
  include interface with any contractors;
• Identification of the major tasks to be undertaken, deliverables for each task and individual or organizational responsibilities for
  completing each task;
• Scheduling of major tasks to meet overall program time constraints;
• Identification of major reviews and decision points;
• Selection of reviewers, the composition of review teams (contract manufacturer in many cases) and procedures to be followed
  by reviewers;
• Controls for design documentation;
• Notification activities—suppliers, contract manufacturers, clinicians, etc.

Planning enables greater control over the design and development process by clearly communicating the facets of design control and documenting the simple stages that we must have in place at the end of this early-on process. The plan keeps everyone on track and conscious of all basic deliverables necessary when bringing a Class II or III medical device to market.

Design activities should be specified at the level of detail necessary for carrying out the design process. The extent of design and development planning is dependent upon the size of the developing organization and the size and complexity of the product to be developed. As you can imagine, the design process should be kept at a minimum because commonly, it’s only the inventor, maybe a lawyer friend who wants to own part of the device (and future royalties) and me, the consultant. I usually develop a comprehensive (but very simple) design and development plan specifically tailored to each device type.

No amount of planning can eliminate all development risk. There is inherent conflict between the desire to maximize performance and the need to meet business objectives, including development deadlines. Impending deadlines create colossal pressures to cut regulatory corners. Effective and enforceable plans help to combat this dilemma by ensuring that everyone is totally aware of the commercialization pressure points. When allowances to the clock are proposed, they must be justified and supported with reliable science, documented engineering and regulatory/quality compliance.