MDSAP(Medical device single audit program)

International Medical Device Regulators Forum (IMDRF) developed a MDSAP program to conduct regulatory audits of quality management systems (QMS) of manufacturers of medical devices.

MDSAP program covers the below quality management systems requiremenrts.

• Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
• Quality Management System requirements of the Conformity Assessment Procedures of the Australian Therapeutic Goods (Medical  Devices) Regulations (TG(MD)R Sch3)
• Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013)
• Japan Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169)
• Quality System Regulation (21 CFR Part 820)

MD SAP members are listed below,

• Therapeutic Goods Administration of Australia
• Brazil’s Agência Nacional de Vigilância Sanitária
• Health Canada
• Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
• U.S. Food and Drug Administration

MDSAP audit uses a process approach and built based on a foundation of risk management.MDSAP audit approach is available here.

– Management

– Measurement, Analysis and Improvement

– Design and Development

– Production and Service Controls.

– Purchasing

– Medical Device Adverse Events and Advisory Notices Reporting

– Device Marketing Authorization and Facility Registration.

Audit approach also have links to the applicable regulatory requirements for participating jurisdictions 

Kindly refer the US FDA CDRH Learn- Inspections - Global Harmonization to know more about MDSAP

US FDA Expanded Access for Medical Devices

Expanded access pathway allows the manufactures or physician to use an investigational medical product to use the patients with a serious or life-threatening disease or condition when there are no available alternative options.

There are three below options are available,

• Emergency Use
• Compassionate Use (or Individual Patient/Small Group Access)
• Treatment Investigational Device Exemption (IDE)

Emergency use

During emergency, investigational device can be used immediately, to treat an individual patient life-threatening situation (there are no alternative options and no time to use existing procedures to get FDA approval for the use).

Physician shall follow the patient protection procedures as possible. Some of the protection procedures are getting concern from patient (Informed consent process), Concurrence from Institutional Review Board (IRB) chairperson and Authorization from the device manufacturer.

Reporting of Emergency use

• Criteria: Devices with IDE    
• Who report: IDE sponsor
• Timelines: within 5 days
• Information to be submitted: IDE Report

• Criteria: Devices without IDE
• Who report: physician 
• Timelines: within 5 days
• Information to be submitted: a description of device used, details of the case, and the patient protection measures that were followed

Compassionate Use (or Individual Patient/Small Group Access)

If there is investigational device is the only option to treat a patient faced with a serious or life-threatening disease or condition.

First device manufacturer shall agree to provide the device under compassionate use.

Approval process for devices with IDE

IDE sponsor should submit an IDE supplement requesting approval for a compassionate use.

IDE supplement contents,

• Patient conditions and circumstances necessitating treatment
• why alternative therapies are unsatisfactory
• deviations from approved clinical protocol to treat the patient
• Patient protection measures

Approval process for devices without IDE

Physician or manufacturer shall submit the compassionate use request to FDA with above information and along with a description of the device provided by the manufacturer

Timelines for review

 IDE supplements have the same statutory 30-day review cycle. Average timelines are within 15 days of receipt.

FDA Actions: Approve, Approve with conditions, or Disapprove the request.

Follow-up Report: Within 45 days, the person who submitted the request shall provide the below details to FDA,

• Patient outcome
• If any problems occurred because of device use

Treatment Investigational Device Exemption (IDE)

If an approved IDE is extended under new IDE to include additional patients with life-threatening or serious diseases. This is called a treatment IDE.

Treatment IDE Application contents are listed below,

1. Name, address, and telephone number of the sponsor
2. Intended use of the device, the criteria for patient selection, and a written protocol describing the treatment use
3. Rationale for use of the device
4. Description of clinical procedures, laboratory tests, or other measures that will be used to evaluate the effects of the device and to minimize risk
5. Procedures for monitoring the treatment use
6. Name and address of the monitor
7. Instructions for use for the device and all other Labeling 
8. Information that is relevant to the safety and effectiveness of the device for the intended treatment use
9. A statement of the sponsor's commitment to meet all applicable responsibilities under the IDE regulations
10. Example of the agreement to be signed by all investigators participating in the treatment IDE and certification that no investigator will be added to the treatment IDE before the agreement is signed
11. Device price (if sold) and a statement indicating that the price is based on manufacturing and handling costs only

FDA actions:Approve, Disapprove or withdrawal of approval of treatment IDEs

Follow-up Report:

• To whom reported: IRB and FDA    
• Who report: Sponsor
• Timelines: Semi-annual basis
• Information to be submitted: Progress reports      

References:

Expanded Access

Expanded Access for Medical Devices

 

 

 

 

US FDA Custom device

 Regulatory Authority: Section 520(b) of the Food, Drug, and Cosmetic Act (FD&C Act) provides the basis for the Custom Device Exemption Program.

Types of Custom devices,

Patient-centric: Device is made to treat a patient’s sufficiently rare condition

Physician-centric: Device is made to satisfy a physician’s unique special need remains with that physician for use in his/her practice

Also note that a single device cannot be patient- and physician-centric.

To qualify as a custom device. The following requirements needs to be followed. The following figure shows the FDA requirements.

Custom devices are exempt from 510(k) and Premarket Approval (PMA) submissions.

Custom Devices are not exempt from any other requirements, including, but not limited to,

• Quality System Regulation, including Design Controls (21 CFR Part 820)
• Medical Device Reporting (21 CFR Part 803)
• Labeling (21 CFR Part 801)
• Corrections and Removals (21 CFR Part 806)
• Registration and Listing (21 CFR Part 807)

Clinical investigations of custom  devices cannot be practically conducted because they are used to treat sufficiently rare conditions or rare physician needs.

In addition to 21 CFR 801 labeling requirements, Custom device shall have below information,

• a statement that the device is a custom device
• the name of the ordering physician
• identifying information for the patient (if applicable) whom the device is intended to treat
• indications for use
• sterilization status
• relevant composition information (materials, components, etc.)
• storage conditions.

Click here to know European MDR Custom made device.

 References:

CDRH Learn Custom device

CustomDevice Exemption-Guidance 

 

Software

European Union: 

Software is defined as a set of instructions that processes input data and creates output data.

Software definitions per MDCG 2019-11 given,

 How to qualify the software as a medical device/in vitro diagnostic medical device software

Shall meet the definition of software according to the MDCG 2019-11 and the definition of a MD/IVD  according to Article 2(1) of MDR/IVDR

 MDR classification rules: Rules 9, 10, 11, 12, 13, 15 and 22 Annex VIII

IVDR Classification rules:To classify in vitro diagnostic medical device software all rules shall be considered.

EU Regulations References:

Is your software a Medical Device? Info graphic

MDCG 2019-11 Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746

US FDA Software as Medical Device (SaMD)

“software intended to be used for more than one or more medical purposes that perform these purposes without being part of a hardware medical device.”

 How to qualify the software as a medical device/in vitro diagnostic medical device software

Meet the definition of software according Federal Food Drug & Cosmetic (FD&C) Act section 201(h) device definition.Some of the software functions are excluded from device definition.

 IMDRF Guidance documents.

Softwareas a Medical Device (SaMD): Key Definitions (IMDRF/SaMD WG/N10FINAL:2013)

Softwareas a Medical Device (SaMD): Possible Framework for Risk Categorization andCorresponding Considerations (IMDRF/SaMD WG/N12FINAL:2014)

Softwareas a Medical Device (SaMD): Application of Quality Management System (IMDRF/SaMD WG/N23 FINAL:2015)

Software as a Medical Device (SaMD): Clinical Evaluation(IMDRF/SaMD WG/N41FINAL:2017)