Risk cannot always be eliminated by design solutions. This is why medical devices use protective measures (i.e., – alarms) and inform users of residual risks (i.e., – warnings and contraindications in an Instructions For Use (IFU). The “ALARP” concept has a legal interpretation which implies financial considerations. Instead of claiming that the residual risks are ALARP, the company needs to show the risks are reduced AFAP with demonstrating objective evidence that the risk control options were considered and implemented. But only after applying the risk management policy to determine if additional risk controls need to be evaluated, can any residual risks be ALARP. But in general, risk control options should never be ruled out due to cost.
http://medicaldeviceacademy.com/en-iso-149712012-deviation-3-risk-reduction/

AFAP is deemed acceptable when death or serious deterioration of health is unlikely. ALARP is not acceptable with regard to economic consideration. ALARP has more to do with acceptability of the risk. Also ISO 14971 allows risks to be reduced ALARP and the European Directives require all risks to be reduced AFAP without economic consideration.

Another term I found - BAR (Broadly Acceptable Region) which is shown in the image above.

Medical device manufacturers cannot depend on procedures to decrease the risk as they used to do in the past. Additionally labeling must be still shown on the medical devices, but it cannot be longer used to mitigate risk. The idea of decreasing risk as low as reasonably practicable (ALARP), which contains economic concerns, was swapped with an obligation to decrease risk as far as possible (AFAP). This way the complexity of the reduction and risk assessment is more complex than it was in the past. Additionally, the evaluation of the risks in the phase design and in the clinical stage is much different.

Thanks

I found that the ALARP concept contains legal interpretation of the regulatory process that promotes financial consideration in higher regard than of the requirements of safety and performance of medical devices. Contradicting this approach, AFAP requires that all ventures of safety must be addressed in the intent of the consumer and effectiveness of the product rather than capital gain of the corporation. Under AFAP standards there are two defined justifications for the lack of implementation of risk-preventative measures. The first indicates that the additional risk control will not provide additional support for the system, such as an additional alarm when a previous alarm is functioning. The second states that a risk control system does not have to be implemented if there is a more effective risk control that can not be simultaneously executed due to various scenarios such as spatial boundaries. By implementing this new standard of risk mitigation, companies must demonstrate that they have considered and implemented all necessary means of addressing risk of a product or developed system.

ALAPRP is 'as low as reasonably practicable'. It requires weighing the risk against the time,cost needed to control it. Deciding whether the risk is ALARP is quite challenging because it requires the duty holder to exercise judgement. In a complex situation build on good practice are used to make formal decision that includes cost -benefit analysis. Everyone in the organization should know about it because it is a fundamental to the work of whole organization. AFAP is reducing risk as far as possible. As the complexity of risk increases the reduction becomes more complicated. It means little risk reduction requires before risk at hand becomes negligible.

I think the term is meant to signify the balance between reducing risks as much as cost effectively possible for that medical device. The transition from ALARP to AFAP suggests that there is more emphasis on reducing risk as much as possible despite their cost or practicality concerns, which is driven by the need for higher safety standards and the need for more effective medical devices and less risks of failure.

Although this transition may seem like a no-brainer, there are some inherent roadblocks to achieving this maximum efficiency, like increased costs, potential technology barriers, and the need for more comprehensive risk management strategies that would require revision of current risk management strategies. This is why it is essential for the middle ground to be reached in terms of providing as much safety as possible in the most efficient and cost effective way possible.