On September 20, 2019, the FDA issued a draft guidance entitled The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program : Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff. The comment period is open under docket FDA-2019-D-3805 for 90 days.
Program je enostaven za uporabo, omogo. Program strokovnega usposabljanja in preizkusa znanja za upravljanje. I jeste u pitanju 4ro polni fid. Dvopolni je bio samo od 16A, pa sam se bojao da ce iskakati, ako u isto vreme budu radili. Servisne sheme Makita alata Servis Alati Mili. Sam svoj majstor, popravite svoj alat uz na. Shema elektro instalacije za imt 539. Dakle, treba mi raspored osiguraca za IMT 539, 549, te za ZMAJ 133.
On October 28, 2019, the FDA hosted a webinar for manufacturers, accreditation bodies, testing labs, standards organizations and others interested in learning more about this draft guidance and the ASCA Pilot.
CDRH's Standards and Conformity Assessment Program is committed to the advancement of regulatory science in support of medical device review. An integral part of a least-burdensome approach to device review is a reliance upon international consensus standards.
In accordance with amendments made to Section 514 of the Federal Food, Drug & Cosmetic Act by the FDA Reauthorization Act of 2017, and as part of the enactment of the Medical Device User Fee Amendments of 2017, the FDA intends to implement a pilot conformity assessment initiative, entitled the Accreditation Scheme for Conformity Assessment, or ASCA. This voluntary, pilot program, is designed to increase consistency and predictability in the FDA's approach to assessing conformance with ASCA-eligible standards in medical device premarket reviews.
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The ASCA Pilot is intended to reduce regulatory burden by enhancing product reviewers' confidence in medical device testing, which should decrease the need for internal FDA consultations, complete test report reviews, and additional information requests for standards which are part of the Pilot Program. Ultimately, the ASCA Pilot is intended to help the FDA ensure safe, effective, and high-quality medical devices are available to patients without avoidable delay.
On this page:
How does FDA envision the ASCA Pilot would work?
The FDA is proposing that accreditation bodies may request recognition from the FDA for their qualifications and agreements to the terms of participation in the ASCA Pilot. Once an accreditation body is recognized by the FDA to a particular scope of standards and testing, the accreditation body may in turn accredit testing laboratories (including in-house and third party) to ISO/IEC 17025 and the ASCA program specifications, which are proposed in the ASCA draft guidance.
After a testing laboratory is accredited by an accreditation body, it can apply to the FDA in a two-step process to gain ASCA accreditation. In the first step, the FDA recognizes the testing laboratory for the purposes of the ASCA Pilot, identifying the scope of ASCA-eligible standards and test methods for that laboratory. In the second step, the FDA grants it ASCA Accreditation.
Once a testing laboratory has ASCA Accreditation, it may conduct testing for manufacturers to determine conformance of a device with an ASCA-eligible standard. When a testing laboratory with ASCA Accreditation conducts testing within its recognized scope, a complete test report containing the information specified in the ASCA Pilot would be provided to the device manufacturer, who could then include a Declaration of Conformity (DOC) (along with supplemental documentation such as summary test report(s)) as part of a premarket submission to the FDA. The 2018 guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices provides additional helpful information about Declarations of Conformity and their important role in regulatory review.
How is the ASCA Pilot being developed?
The ASCA Pilot emerged from discussions with device manufacturers and other stakeholders prior to the negotiations for the Medical Device User Fee Amendments of 2017 (MDUFA IV), and it was further refined during the negotiations and was included in section 514(d) of the FD&C Act. The FDA established an internal team to develop the tenets of the ASCA Pilot Program. Using a least-burdensome approach, the team incorporated existing international conformity assessment standards and practices where practical.
The ASCA team relied heavily upon input from external stakeholders as well. The first opportunity for public input was a request for comments published in the Federal Register in May of 2017. A second key element of outreach was the public workshop held May 22-23, 2018. Several hundred individuals from across the medical device manufacturing and standards conformity assessment communities participated, in person or online. This collaboration proved invaluable as the ASCA Pilot program took shape.
The Draft Guidance includes more specifics about the operational aspects of the ASCA Pilot Program and allows for another opportunity for public comments regarding the proposed ASCA Pilot.
Who may participate in the ASCA Pilot?
The ASCA Pilot will include participation from accreditation bodies, testing laboratories, device manufacturers, and FDA staff. Information on how FDA proposes that accreditation bodies and testing laboratories may participate in the ASCA Pilot is discussed in the draft guidance (Section VIII.B.).
Which standards are proposed for inclusion in the ASCA Pilot?
The FDA is proposing that specific identified standards be included in the ASCA Pilot based on comments received in response to the 2017 Federal Register notice (82 FR 22548) and input from stakeholders at the 2018 ASCA public workshop. In accordance with the MDUFA IV commitment letter, the Pilot Program will include both cross-cutting (horizontal) and device-specific (vertical) standards, which are of public health significance, and have or are able to provide the means for establishing acceptance criteria. The table below is a simplified version from Section VII of the draft guidance.
Table: Proposed List of Standards and Test Methods to Be Used During the ASCA Pilot
Biological evaluation of medical devices
|Standard||Standard Title||Test method(s)|
|ISO 10993-4||ISO 10993-4: Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood||Complement Activation|
|ISO 10993-4 and ASTM F756||ISO 10993-4: Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood|
ASTM F756: Standard Practice for Assessment of Hemolytic Properties of Materials
|Direct and Indirect Hemolysis|
|ISO 10993-5||ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity||MEM Elution Cytotoxicity|
|ISO 10993-10||ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization||Dermal Irritation, Intracutaneous Reactivity Irritation, Guinea Pig Maximization Sensitization, and Closed Patch Sensitization|
|ISO 10993-11||ISO 10993-11: Biological evaluation of medical devices – Part 11: Tests for systemic toxicity||Acute Systemic Toxicity|
|ISO 10993-11 and USP 151||ISO 10993-11: Biological evaluation of medical devices – Part 11: Tests for systemic toxicity|
USP <151>: Pyrogen Test
|ISO 10993-12||ISO 10993-12: Biological evaluation of medical devices – Part 12: Sample preparation and reference materials||Sample preparation for all test types|
Basic safety and essential performance
|Standard||Standard Title||Test method(s)|
|ANSI/AAMI 60601-1||Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (along with the FDA-recognized collateral and particular standards in the IEC/ISO 60601/80601 family)|
|IEC 61010-1||Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements (along with the FDA-recognized particular standards in the IEC 61010 family)|
When FDA finalizes the guidance, the standards included in the ASCA Pilot may be different.
Manufacturers may continue to rely on other standards and provide declarations of conformity in premarket submissions; however, other standards will not be eligible for the benefits of the ASCA Pilot. Refer to Section VII. of the draft guidance for further information.
Will participation in the ASCA Pilot be voluntary?
How would an accreditation body participate?
As proposed, an accreditation body or testing laboratory would apply to participate in the ASCA Pilot by submitting, via email to [email protected], documentation demonstrating how the applicant organization addresses the ASCA Pilot qualifications. Please refer to the draft guidance for details on what information is proposed to be included in applications (Appendix C).
The FDA is proposing to review applications from accreditation bodies and testing laboratories within 60 calendar days. After reviewing application contents, the FDA intends to notify the applicant organization via email of the issues, if any, that may preclude ASCA Pilot participation so that any issues may be addressed (if possible). When review is complete, the FDA intends to inform the applicant organization via email of our decision, including, for recognition, a scope and expiration date. Note that the scope would include only standards in the ASCA Pilot for which competence has been demonstrated. To renew a recognition, an accreditation body or testing laboratory would apply to continue ASCA Pilot participation 6 months prior to the expiration of its recognition following the same process. For further information, refer to the draft guidance (Section VIII.B.).
How would a testing laboratory participate?
The FDA is proposing that once an accreditation body is recognized by FDA to a particular scope, it may in turn accredit testing laboratories to ISO/IEC 17025 and the ASCA program specifications.
As proposed, after a testing laboratory is accredited by an accreditation body, it would apply to FDA in a two-step process to gain ASCA Accreditation. In the first step, FDA recognizes it for the purposes of the ASCA Pilot, identifying the scope of ASCA-eligible standards and test methods, and then grants ASCA Accreditation. Note that ASCA Accreditation is provided by FDA whereas an accreditation body may accredit a testing laboratory independent of participation in the ASCA Pilot. Once a testing laboratory has ASCA Accreditation, it could conduct testing for manufacturers to determine conformance of a device with a standard included in the ASCA Pilot. When a testing laboratory with ASCA Accreditation conducts such testing, a complete test report containing the information specified by the ASCA Pilot would be provided to the device manufacturer, which could then include a Declaration of Conformity (DOC) (along with supplemental documentation such as summary test reports, examples of which appear in the draft guidance), as part of a premarket submission to FDA. We encourage readers to become familiar with the 2018 guidance, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices for more information about DOCs and their important role in regulatory review.
How would a manufacturer participate in the ASCA Pilot?
The FDA is proposing that device manufacturers could voluntarily engage with testing laboratories with ASCA Accreditation to conduct testing to ASCA-eligible standards and include the results in a premarket submission. When an ASCA-accredited testing laboratory conducts such testing, a complete test report containing the information specified by the ASCA Pilot would be provided to the device manufacturer, which could then include a Declaration of Conformity (DOC) (along with supplemental documentation such as summary test report(s), examples of which appear in the draft guidance), as part of a premarket submission to FDA.
The ASCA Pilot will not alter the device manufacturer's responsibility to address relevant information in a premarket submission. This includes the responsibility to document how testing supports marketing authorization, even when such testing is performed by a testing laboratory with ASCA Accreditation. For further information, refer to the draft guidance, which proposes information on participation (Section VIII.) and example ASCA summary test reports (Appendices E and F) recommended for premarket submissions. Please see the 2018 guidance, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices for further recommendations on the use of standards in device submissions.
Will there be a fee for participation in the ASCA Pilot?
FDA will not charge a fee for accreditation bodies or testing laboratories to participate in the ASCA Pilot. Manufacturers have funded the program through the MDUFA IV User Fee program; however, there is no additional fee for manufacturers to participate in the ASCA Pilot.
When does the ASCA Pilot launch?
As indicated in Section 514(d) of the FD&C Act, ASCA Pilot program initiation should occur no later than September 30, 2020.
- FDA Fact Sheet: The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Draft Guidance (September 2019) (PDF - 194KB)
- ASCA Public Workshop (2018)
If you have additional questions, you may email [email protected]
Recently I received this small digital storage oscilloscope called DSO Shell (DSO150) made by Chinese company called JYETech. Device is purchased as a KIT which means that some assembly at home is required before device can be used.
I must say that I am pleasantly surprised on how the device performs. It is a very handy 200kHz DSO that can be used to debug various signals up to 200kHz and 100Vpp.
Entire DIY assembly process can be seen in the video after the break. Video is not in english, but English subtitles are available!
This is a modification of my simple IR light dimmer v1 that you should also check out. Modification is mostly in hardware so that dimmer does not require both phase and neutral wires to operate. I am releasing source code for this v2 version for you to modify and have fun!
How this device works is pretty cool, it powers itself from the mains through the load (usually a light bulb but it can also be a resistive heating element). The way it turns the load ON is by short-circuiting its own power supply! You can control it with your own TV remote controller - all you need is 4 spare buttons (usually those used for Teletext so that they don't interfere with normal TV usage).
If you ever need a robust button for your next project you should really consider using a piezoelectric crystal as a main component. Piezo crystal has a property to generate voltage when mechanical force is applied by bending it, striking or even touching. This crystal is also used in car alarms as a vibration sensor.
In order to turn on a relay or have a transistor output to control some other electronic device, you need to build a debouncer circuit and also to prolong short bursts of impulse coming from piezo. The crystal is simply connected to a base of NPN transistor that will open when piezo generates enough voltage. This impulse if then fed into the NE555 which is in monostable configuration and it will issue a 1 second pulse after being triggered. How cool is that!
If you have some RGB LED strip leftover from your previous project, do not let it go to waste. Why not building a simple three channel PWM driver with IR remote control support to power it with? It is a great weekend project that anyone can build.
This project is based on an old PIC16F84 we had lying around, three 1A transistors and an IR remote receiver. The firmware is written in PICBasic and is commented out so beginners could learn a thing or two about the way that device works. There are few firmwares available that decode: Nokia remote protocol, Sony and Philips.
Source: Edo Lelic
Big old wall clocks that were used in facilities such as schools, factories and hospitals are very appealing and will probably never go out of style. They are very durable and almost never break down due to very simple mechanism they have.
This mechanism is actually pretty simple, it is just an impulse motor (two coils) and a couple of gears - no further complications. This is a blessing and also a curse for these antique clocks because for their operation they now require something called a master clock. Master clock is an electronic device that sends pulses to these slave clocks so that they can work.
Source: Edo Lelic
Are days of lost packages behind us? Not really, but we might be one step closer to the solution, at least for the local-mail.
[David] managed to create a concept called SafeDrop that could be used by the postal services or local courier delivery agencies for packet delivery. This SafeDrop is actually a locked box filled with electronics that can be unlocked only by the intended packet recipient by scanning the secret barcode. Electric lock is made with servo motor and all electronics are built using the Intel Edison IoT platform.
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Maybe it is a hardware overkill at this point, but it sure proves the concept.
Source: David Xie
If you have an analog intercom in your apartment and feel bored every time you need to unlock the doors, this might be your next project!
It is an addition to your analog intercom which is installed in the apartment and is used to unlock the front door by entering a secret passcode. Of course, the passcode is not a traditional numerical one, it actually consists of short and long rings! To make project even more interesting and fun, the author added an audio playback option to play funny lines when wrong passcode is entered.
This time we would like to present you with a new Arduino board named Croduino, made in Croatia by e-radionica crew. This is actually a collection of Croduino boards that are fully compatible with Arduino.
One of these boards is a Croduino Basic2 which incorporates ATmega328 and CP2102 USB<->Serial converter. There is also a wearable-duino board called Damba that has Attiny85 onboard. Their latest project is ESP8266 WiFi Croduino module for your next IoT project!