In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions - Appendix B - 510(K) Response Letter

 IVD Manual Appendixes Index

APPENDIX B - 510(k) RESPONSE LETTER

Sample 1 - Substantially Equivalent

CLIA-SE
CLASSIFIED AND NOT CLASSIFIED 
TO BE USED FOR 510(k)s K960001 AND AFTER
[CONTACT PERSON]
[COMPANY]
[ADDRESS]
[CITY, STATE, ZIP CODE]

Re: [510(k) NUMBER]
Trade Name: [               ]
Regulatory Class:
Product Code: [               ]
Dated:
Received:

Dear [ADDRESSEE]:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice on FDA's labeling regulations (21 CFR Part 801 and §809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained by contacting the Division of Small Manufacturers Assistance by phone at 800-638­2041, 301-443­6597, or by fax at 301-443-8818.

Enclosure

Sample 2 - Not Substantially Equivalent

[510(k) HOLDER, COMPANY NAME]
[C/O COMPANY REPRESENTATIVE, THIRD PARTY, OR CONSULTANT (IF ANY)]
[COMPANY REPRESENTATIVE, THIRD PARTY, OR CONSULTANT ADDRESS]
[CITY, STATE, ZIP CODE]


Re: [510(k) NUMBER]
Trade Name: [               ]
Regulatory Class: III
Dated:
Received:

Dear [ADDRESSEE]:

We have reviewed your Section 510(k) notification of intent to market the device referenced above. We have determined the device is not substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to any device which has been reclassified into class I (General Controls) or class II (Special Controls). This decision is based on the fact that [SEE END OF LETTER FOR SUGGESTED WORDING].

Therefore, this device is classified by statute into class III (Premarket Approval), under Section 513(f) of the Federal Food, Drug, and Cosmetic Act (Act).

Section 515(a)(2) of the Act requires a class III device to have an approved premarket approval application (PMA) before it can be legally marketed, unless the device is reclassified.

Any commercial distribution of this device prior to approval of a PMA, or the effective date of any order by the Food and Drug Administration re-classifying this device into class I or II, would be a violation of the Act. Clinical investigations of this device must be conducted in accordance with the investigational device exemptions (IDE) regulations.

If you wish to pursue the marketing of this device and need information or assistance for preparing PMA, IDE, or reclassification submissions, please contact the Division of Small Manufacturers Assistance by phone at 800-638-2041, 301-443-6597, or by fax at 301-443-8818.

Reasons for Not Substantially Equivalent Decisions

1. This decision is based on the fact that we are not aware of a legally marketed preamendments device labeled or promoted for [specify indication]. (This relates to the indication of any type device for the use -- not the technology.)
2. This decision is based on the fact that your device has a new indication [specify] that alters the therapeutic/diagnostic effect [choose one or the other], impacting safety and effectiveness, and is therefore a new intended use.
3. This decision is based on the fact that your device has new technological characteristics, that could affect safety and effectiveness, and raises a new type[s] safety and effectiveness question [specify new question].
4. This decision is based on the fact that the performance data you have provided did not demonstrate your device to be as safe and effective as legally marketed devices [specifically a device marketed prior to May 28, 1976 or a device which has been reclassified from class III to class II or I (the predicate), or a device found to be substantially equivalent through the 510(k) process].